New in 25R2 Limited Release

Limited Release Dates: April 25, 2025 (25R1.2); May 30, 2025 (25R1.3); June 20, 2025 (25R1.4) | General Release Date: August 1, 2025

Beginning with 25R1.3 and for all subsequent releases, Safety, RegulatoryOne, and Veeva Claims release on the same date as the Veeva Vault Platform.

We are pleased to bring you new functionality with each limited release. These release notes are updated with upcoming new features one week before the limited release date. See the following explanations for enablement options:

• Auto-on: Automatically activated and no configuration is required before using the feature; in some cases, a new feature is dependent on another feature that must be enabled or configured.
• Admin Checkbox: Admins must turn on the feature with an Admin checkbox. Some “Auto-On” features have a checkbox setting that hides the feature; these will show “Auto-On.”
• Configuration: Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, an Admin must add document templates before users can create documents from templates.
• Support: On/off option controlled by Support.
• Available for Use: Used only by the eConsent, eCOA, and SiteVault applications. Sponsors must make a study-specific configuration change to implement new capabilities.

Platform

Highlights

Action TriggerConfiguration25R1.3

Action Triggers allow Administrators to write simple conditional logic that executes when a CREATE, UPDATE, or DELETE operation occurs on a record. This enables Vault to perform actions previously only possible using the Vault Java SDK Record Triggers. Here are some examples:

• Send a notification if a field is updated
• Update a field when another field is updated
• Update a field on related records when a field is updated (parent or child)
• Start a workflow when a record is created
• Prevent saving a record under defined conditions and provide a custom error message

Action Triggers are simple and intuitive logic written as blocks of IF-THEN-ELSE statements, which can be created as BEFORE and AFTER events for the CREATE, UPDATE, and DELETE operations. This feature comes with a context-sensitive editor to assist in writing the Action Trigger. The complete list of possible actions include:

• Create, Update, or Delete records
• Send a Notification
• Change State
• Start or Cancel a Workflow
• Cancel the operation with a custom message, such as “prevent creation of record”

Learn more about Action Triggers.

Document Readiness PanelAuto-on25R1.2

Vault users and Admins now have improved visibility into the processes contributing to a document’s readiness for use in Vault. The Document Readiness panel in the document viewer displays statuses related to rendition generation, searchability, and annotation readiness. This panel also displays warnings related to these operations and information on how to address them.

The panel is accessible via a new icon in the Doc Info pane:

The panel displays the Content Processing and Warnings sections.

The Content Processing section displays high-level status information of standard Vault rendition processes:

• Viewable: Indicates the status of the viewable rendition creation.
• Searchable: Indicates the searchability status of the document content in the document viewer or when searching document content using Advanced Search.
• Ready to Annotate: Indicates whether the document is ready to be annotated.

The Warnings section is not displayed in the majority of cases, but if issues are encountered during processing, such as if Vault is unable to resolve merge fields tokens, this section categorizes these issues and allows users to navigate warnings and see recommended solutions.

Additionally, users can ignore warnings.

Ignored warnings remain displayed with lighter text and are moved to the bottom of the list. Warnings ignored on a prior version remain ignored on the latest version (if the warning still exists).

If the Document Readiness panel is not displayed when processing is complete and Vault identifies warnings, a message is displayed to users directing them to review the warnings:

The Document Readiness panel is displayed only to users with Edit Document permission, as those are the users who would have the ability to address any issues if identified. The Document Readiness panel is not displayed on prior versions nor on document versions in a Steady state.

Additionally, a new object for reporting purposes, Document Readiness Metrics (document_readiness_metrics__sys), allows for additional reporting on outstanding issues. To report on document readiness metrics, Admins must create the necessary report type in Admin > Configuration > Report Types.

Learn more about the Document Readiness panel.

Tree SecurityConfiguration25R1.2

Admins now have an additional security configuration option that allows them to grant access to object records based on a defined hierarchical structure. With this structure, users can be granted roles that cascade down through a hierarchy, and have access to object records rolled up through a hierarchy.

Defining the Security Tree

A new object class is available when creating new objects called Security Tree, which facilitates the creation of a Security Tree hierarchy, made of up nodes, for example:

Assigning Objects to Tree Nodes

Objects can be assigned to specific Security Trees in configuration, and records can be assigned to specific nodes:

Once an object record is assigned to a security tree node, it will be visible to any users assigned at the same node, or at any node above it in the hierarchy. For example, Record C would be visible to users assigned into the Vendor Management, EVP, or CEO security tree nodes.

Assigning Users to Tree Nodes

Users can be granted application role access using a system-managed user tree assignment object. A user assigned to a node receives direct access to objects assigned to that same node. For instance, this assignment grants User A Viewer access to all records assigned to the EVP node as well as to any records associated to child nodes:

The above would grant Viewer access for User A to Vendor records associated to the Vendor Management node since Vendor Management is a child node of EVP. More specific assignments could be added to increase access. For instance, if the user also has an Editor application role assignment to the Vendor Management node:

The assignment record for Editor to the Vendor Management node increases the user’s access from Viewer to Editor for records associated with the Vendor Management node, while Viewer access is maintained on records associated with other nodes at or underneath EVP.

Static Assignments or Automatic Assignments (Based on User Reference Field)

Assigning a security tree node to specific object records can be done individually (called “static assignment”), or Vault can automatically assign records once they are created if the Restrict Users to a Single Node Assignment option is checked on the Security Tree-class object and the object being secured contains a User reference field. When enabled, Vault will evaluate what node the designated User within the configured User reference field has been assigned to, and create a system-managed record assignment to the same security tree node.

This option can only be selected if there are no existing static assignments for users. Once selected, the controlled object can be set to reference a User field for granting access:

With this configuration, individual object tree assignments per record are not needed; however, users can only be assigned to a single security tree node.

Learn more about Security Tree Administration.

Child Object SecurityConfiguration25R1.2

Admins now have a simple option for enabling user access to child object records based on their access to the parent record. When a parent-child relationship exists, Admins will now have a checkbox called Replicate sharing settings from parent object available on the child object’s field that references the parent:

Prior to 25R2, basing a child object’s access on a parent required replicating security configuration (such as custom sharing rules, matching sharing rules and/or a security tree) on the parent object and all of the child objects. This option provides a faster and simpler configuration approach for Admins in these scenarios by automatically inheriting roles assigned on the parent object records.

When enabling this setting on a relationship, Vault deletes any existing matching sharing rules or custom sharing rules on the child object:

This setting is only available if the parent object has custom sharing rules, matching sharing rules, or a security tree enabled. This option may not be available for certain standard objects.

Learn more about Child Object Security.

User Usage LevelAuto-on25R1.2

Vault now automatically calculates a user’s sage level, allowing customers to easily identify users based on their level of system usage.

This calculation is based on the frequency of Vault use as well as the number of active minutes that users are in Vault, averaged up to 100 days. There are five (5) levels:

Usage Level	Description
Occasional	Uses Vault less than once a week.
Light	Uses Vault weekly for less than 30 minutes.
Medium	Uses Vault multiple days per week for 30 minutes.
Heavy	Uses Vault daily for less than two (2) hours.
Very Heavy	Uses Vault daily for more than two (2) hours.

This information is recalculated daily.

Customers can view the Usage Level field on the User object, though the field is not added to the User object layout by default.

Since this is an available field on the User object, it can also be used in reports and dashboards:

Learn more about User Usage Level.

CountIf & CountA for Multi-Item Workflow ConditionsConfiguration25R1.2

The existing CountA() and the new CountIf() functions now enable Admins to configure Decision step and Action step conditions that use the number of tasks and items (documents or objects):

• CountA() will return the total number of tasks or items
• CountIf() will return the total number of tasks or items matching a criteria

If you want to make sure no tasks were canceled, you can use CountIf() to ensure the number of tasks where the status is TaskStatus.CANCELED is zero (0):

CountIf(Tasks.review__c.status, x, x = TaskStatus.CANCELED) = 0

As a more complex example, you may want to ensure that all tasks assigned to all participants have been approved and that there were no canceled tasks from a critical participant group, like Legal or Regulatory. Before this feature, if tasks were canceled then the “all verdicts equals Approved” would still be true. However, the below formula-based evaluation can ensure all participants completed their tasks, without cancellation:

AND( CountIf(Tasks.review__c.verdict, x, x = "Approved") = CountA(Tasks.review__c.verdict), CountIf(Tasks.review__c.status, x, x = TaskStatus.CANCELED) = 0 )

Learn more about the Vault Formula Reference Guide.

Managing Documents

Collaborative Authoring: Automatic Mentioning for Task ReassignmentAuto-on25R1.2

When using collaborative authoring workflow actions, Vault now ensures that new task owners can be automatically @ mentioned in a collaboration session when a task is reassigned.

An enhancement was introduced in 25R1 that allows Vault to automatically allow workflow participants to be @ mentioned in collaborative authoring; this enhancement extends that capability to ensure that the same behavior is applied when tasks are reassigned.

Learn more about Configuring Collaborative Authoring Workflows.

Synchronous Lifecycle & Workflow Actions for Collaborative AuthoringAuto-on25R1.3

When using lifecycle and workflow actions for collaborative authoring, Vault now executes the Check Out, Check In, and Cancel Editing actions synchronously if the workflow contains only one (1) document or the state change is performed on a single document only.

Prior to 25R2, these actions would always execute asynchronously, regardless of how many documents were affected. This could lead to user confusion; for instance, the page would refresh but the document would still appear as checked out because the asynchronous action had not finished. The user would then need to refresh the page again, and would remain on the version that was checked out rather than being taken to the latest version.

Executing these actions synchronously for single-document scenarios improves the user experience and reduces confusion for end users. Once the page has refreshed, users can see that the action has been completed (the document is no longer checked out) and they are on the latest version.

Learn more about Configuring Collaborative Authoring Workflows..

Metadata Clearing on PDF Viewable RenditionsAuto-on25R1.2

Admins can now define whether select metadata values from a source file should be maintained or removed on the PDF Viewable Rendition.

A new Rendition Profile setting is available, Remove document properties from Viewable Rendition, which ensures that all source file metadata (with the exception of the file name) is removed in the Viewable Rendition’s properties. This setting applies to all source files and to automatically generated viewable renditions only. When selected, this setting overrides the Include source document properties in the Viewable Rendition setting.

Learn more about Auto-Generated Viewable Renditions.

Bring Forward Annotations: Use Coordinates for Text PlacementAuto-on25R1.3

When bringing forward text-select annotations including notes, links, and anchors, in cases where the selected text appears more than once in the target version, Vault uses the coordinates of the source annotation to confirm correct placement in the target version, when possible. This includes annotations brought forward manually or automatically, and significantly increases the success rate for automatic placement of brought-forward text annotations.

For example, in this source version, the phrase History of the Modem is annotated twice.

Previously, when the selected text appeared more than once on the same page, those brought-forward annotations would be created as page-level annotations:

With this enhancement, the brought-forward annotations are placed correctly:

Learn more about Bringing Forward Annotations.

Auto Bring Forward Annotations from Latest VersionAuto-on25R1.3

When automatic Bring Forward Annotations is performed on a document, annotations are now brought forward from the latest version only. If there are no eligible annotations in the prior version, no annotations are brought forward. This provides more predictable results and avoids certain unwanted outcomes, such as note annotations resolved in the prior version being brought forward from an earlier version.

Previously, automatic Bring Forward Annotations would bring forward annotations from the latest eligible version, which could include non-latest prior versions.

Allow Document Owner to Delete AnnotationsAuto-on25R1.3

Admins can now allow Document Owners to delete other users’ annotations. This provides the Document Owner role the ability to individually delete any eligible annotation, regardless of who created it.

Prior to 25R2, only the person who created an annotation could delete it. This enhancement removes the additional effort and communication required to remove annotations.

The Document Owner must have the required permissions to delete the annotation, and the document cannot be under Legal Hold. Also, no user can delete an anchor annotation with an inbound reference.

Learn more about Annotating Documents and Managing Annotation Settings.

Filter Annotations by Created DateAuto-on25R1.3

When filtering annotations, users now have an option to filter by the Created Date of the annotation.

This feature supports a common need to focus on annotations created before or after a significant event.

This feature also helps users who previously relied on sorting by date in Notes View, which was deprecated in the 24R3 release.The filter is applied based on the Created Date of the annotation itself, as well as its most recent reply.

When filtering on Created Date, users can use:

• In the range to choose a specific date range, including a single date by specifying the same date in both fields.
• After to choose annotations created after a specific date.
• Before to choose annotations created before a specific date.

All dates is the default setting, which does not filter annotations by created date. Applying this filter is not saved as a user preference.

Learn more about Annotating Documents.

Managing Data

Word Formatted Outputs: Support for Traversing Multiple Outbound Object LevelsAuto-on25R1.2

Word Formatted Outputs now support referencing fields up to three (3) levels of outbound relationships in dot notation (without needing to nest tables) for a single field value. As an example, the following syntax is now supported:

audit__vr.facility__cr.country__cr.abbreviation__v

In that example, Vault is traversing three (3) objects (Audit to Facility to Country) to retrieve the Abbreviation field’s information. Prior to 25R2, only one (1) relationship could be used with dot notation for outbound relationships, which would result in additional nesting of tables to access additional relationships.

This same syntax can also be leveraged within expressions used in ${HideRowIf(...)} and ${HideTableIf(...)} syntax.

Learn more about Managing Word Formatted Output Templates.

Word Formatted Outputs: Print Attachment Field ImagesAuto-on25R1.2

Word Formatted Outputs now support the ability to display an image file from an Attachment field. This functionality was previously supported for image files included as record attachments. This extends the same capability to Attachment fields.

Displaying images from Attachment fields requires appending an imageSize parameter to the field token, where you can define the preferred size:

With the imageSize parameter, Vault scales the image down so its largest dimension (height or width) meets the specified pixel size.

Learn more about Managing Word Formatted Output Templates.

Word Formatted Outputs: Increase Template Page LimitAuto-on25R1.3

Word Formatted Outputs were introduced in the 25R1 release with a ten (10) page limit on a given template file. Based on initial feedback, this limit is being increased from ten (10) pages to 20 pages to support more complex outputs.

Learn more about Managing Word Formatted Output Templates.

Prevent Creation of New Adobe Formatted OutputsAuto-on25R1.2

New Adobe formatted output templates can no longer be created in a Vault. With the introduction of Word Formatted Outputs in 25R1, all new formatted output templates must use Word. Existing Adobe templates can continue to be edited and used.

Related Object Section: Record LimitsAuto-on25R1.3

To ensure good consistent performance when viewing a record detail page, we are limiting the number of related records retrieved in a related object section representing simple join relationships to a max of 10,000 records. For simple join relationships, the related object section displays the “other parent” instead of the simple join object itself, which requires more time to retrieve.

This means that when searching in the related object section, the search will only retrieve results from the first 10,000 simple join records. If Criteria VQL is used, they will be applied on the first 10,000 records rather than on the entire dataset. This can cause the user to see less than 10,000 records at runtime.

Label Limit Increases for LayoutsAuto-on25R1.3

Label limits for object page layouts have been increased to the following:

• Section Help Content: 255 → 500
• Section Label: 40 → 150
• Page Label: 40 → 60
• Layout Label: 100 → 150

Select All for Complex RelationshipsConfiguration25R1.3

Administrators can select a new configuration option, Enable Select All, for complex relationship objects that enables users to select all records when relating multiple records at the same time in a related object section. Previously, this option was only available for simple relationship objects.

Checklists: Long Text & Rich Text Support for CommentsAuto-on25R1.3

Checklists can now be configured to accept Text (1,500), Long Text (32,000), or Rich Text (32,000) comments from respondents related to questions.

Administrators must add the Comment Type field to the Visual Checklist Designer Fields > Question Design section for each relevant checklist type under Admin > Configuration > Checklist Types to see the new option.

Checklists: Available Answer Enhancements & Randomization of Question & Answer OrderAuto-on25R1.3

Previously, the Available Answer records created from Checklists Designs were duplicated whenever an actual Checklist was created from a Checklist Design (instantiated). With this change, copies of Available Answer records are not created for instantiated Checklists anymore. Instead, the set of Available Answers is shared across the Checklists created from the Checklist Design.

As a part of this update, Admins can also randomize Questions and multiple-choice Available Answers in Checklists.

User Experience

Flexible Multilingual SearchAuto-on25R1.3

For Vaults with multi-lingual document handling enabled, users will now have the flexibility to search all languages, all the time, without the need to specify language preferences and without the performance downsides associated with multilingual search.

Query Language Detection

When a user types a search term, Vault will detect the language of the term to ensure that the correct text is searched without any loss of language-specific nuance like verb tense, or singular vs plural nouns. Text in the Vault language and user’s language is always searched.

Language Agnostic Indexing

When the language detection can’t confidently determine the language the user is searching in, the user’s search term can match a new multilingual field in the index that will analyze and split up words for flexible matching no matter what language the text is written in.

This new approach allows users to search all documents they have access to without the need to consider or specify which languages they are searching in. The new multilingual fields combined with fast language detection ensures that Vault can perform these multilingual searches performantly.

With this enhancement, the Search Preferences section on user profiles will be deprecated and removed from the UI. This section was available to allow users to specify what languages to search; since Vault now searches all languages, all the time, these settings are no longer needed.

Summary Email Enhancements & User-Driven NotificationsAuto-on25R1.3

In 25R1, we introduced enhancements to help reduce notification overload for users. Customers had the option to defer these changes to 25R2. Any Vaults that enabled the deferral will now receive these updates:

• Reduce overall email notifications without configuration, specifically by:
  • Setting the Email Preference field to Summary if it was previously set to Every Occurrence on many notification templates (for both Platform and Application-specific templates).
  • Setting the Notification Category field to Tasks for Task Reminder notifications (object_task_reminder_notification__v and task_reminder_notification__v) if they were set to None.
  • Updating the Delivery Interval default value to one (1) hour.
  • Exposing some notification-related fields on the User Profile page by default, including Annotation Replies, Send As Link, Shared Views and Favorite Document notification fields, and a Summary Email Interval picklist, allowing users to adjust their own notification preferences.
    • Tasks and User Mentions are not added by default, though if they were already added previously, they will not be removed.

This change helps all users receive less emails from Vault, while still receiving the information they need in summary emails, and reduces effort for Admins. Admins can still perform additional customization, such as creating custom Notification Categories, adjusting preferences by template, adjusting the Email Summary settings, and adjusting the fields to show on the User Profile page.

Learn more about Summary Emails.

Additional Notification EnhancementsAuto-on25R1.3

Two (2) additional notification enhancements are being introduced to all Vaults to help further reduce notification overload and make summary emails clearer. This would apply both to Vaults that received the Summary Email Enhancements & User-Driven Notifications feature in 25R1, as well as Vaults that opted to defer that feature to 25R2.

Admins can now clear a new flag (enabled by default) that ensures Vault notifications for Favorite Documents changes are not sent if the Favorite Documents category for a user is set to Never. Users without Favorite Documents email preferences will also not receive Vault notifications if the Favorite Documents notification template’s Email Preferences is set to Never. The flag is available in Admin > Settings > General Settings:

With the introduction of the Summary Email Enhancements & User-Driven Notifications feature, users could control whether or not they received email notifications for Favorite Documents, but notifications in Vault itself would always be sent. This change gives users full control, both in Vault as well as via email, to determine whether or not they want to receive notifications for Favorite Documents.

Additionally, the subject line of Vault summary emails will now include the name of the Vault that generated the email. With users receiving more summary emails, this will help users with access to multiple Vaults differentiate which Vault each email applies to.

Learn more about Email and Messages Administration.

Vault Delegation: Usability EnhancementsAuto-on25R1.2

When using Delegate Access functionality, users will now have a more streamlined experience.

When selecting a delegate from the Home tab, Vault will now only display delegated accounts for the Vault the user is currently in:

Prior to 25R2, all delegated accounts across the domain would display to a user, making it unclear what Vault the user would be redirected to when selecting a delegate.

Additionally, when returning to their main account, users will now stay in the Vault that they were accessing as a delegate.

Prior to 25R2, if My Vaults was enabled, the user would be redirected to the My Vaults page, requiring extra clicks for the user to return to the Vault they were working in.

Learn more about Using Delegate Access.

Email to Vault: Bounce NotificationsAdmin Checkbox25R1.2

When using the Email to Vault functionality, Vault will now notify User and Person senders if the Email record is created in a Bounced state.

Vault creates an Email record in the Bounced state when the email is marked as spam, comes from unapproved senders, or fails email authentication (including SPF, DKIM, or DMARC). Prior to 25R2, customers would often need to leverage dynamic flash reports to be notified of Bounced Email records.

This enhancement ensures that the sender is directly notified at the time that the Email record is created.

To enable this functionality, a new checkbox is available in the Inbound Email Address configuration that allows an Admin to decide whether or not they want notifications sent for bounced emails:

This setting is disabled by default on all existing Inbound Email Address configurations.

Learn more about Configuring Email to Vault.

Analytics

Merge Cells in Multi-Pass ReportsAuto-on25R1.3

Multi-Pass reports now support merging cells that contain duplicate values. This enhancement allows Multi-Pass reports to be more easily interpreted within the Vault user interface.

A new option in Advanced Options allows report editors to choose whether the report should merge cells:

With this option selected, report editors can then specify which columns to merge:

This is supported across all data types except Long Text and Rich Text. For object and document references, fields are merged based on ID, not Name. For reports that contain grouping, Vault does not recalculate aggregate values based on cell merging.

Learn more about Multi-Pass Reporting.

Enhanced Contains & Search Operators in Report FiltersAuto-on25R1.3

Users can now filter object text fields in reports using a case-insensitive operator in addition to the existing case-sensitive operator.

Additionally, Long Text and Rich Text fields can now be filtered in reports using a new search operator:

These enhancements provide more flexibility to report users in obtaining the results needed.

Learn more about Using Report Filters.

Enhanced Blank Handling in Report Formula FieldsAuto-on25R1.3

When creating formula fields in reports, users are now given the choice to continue treating blanks as blanks, or to handle them as zeroes (0) or empty strings. This provides flexibility in how report formulas handle blank fields, as well as provides consistency with other Vault formula fields on how blank values are handled.

In the above screenshot, if Blank Field Handling is set to Treat blank fields as blanks, then this returns a blank value overall if the Document Title field is blank. By setting Blank Field Handling to Treat blank fields as zeros and empty strings, Vault returns Hello for any documents where the Document Title field is blank.

Prior to 25R2, users would need to write functions using multiple IsBlank() and If() functions to accomplish this.

Learn more about Report Formula Fields.

Multi-Pass Matrix ReportAuto-on25R1.3

Report creators can now create matrix reports using Multi-Pass report types. A matrix report is structured similarly to a pivot table and has previously only been supported in standard report types. When a Multi-Pass report is selected on the Create Report page, users can now choose Matrix as a Report Format:

In the report editor, any fields across report views can be selected to group rows or group columns.

Similar to standard matrix reports, customers can view grouped data in detailed tabular reports for each group. Customers can customize the column layout in these views by adding columns to the underlying report views. Vault supports up to 100 columns in the detailed display.

In addition to standard reporting capabilities, matrix Multi-Pass reports also support Vault formula fields and advanced filter logic, enabling customers to build more powerful and flexible reports.

This feature is not supported in ladder Multi-Pass reports.

Learn more about Matrix Reports and Multi-Pass Reports.

Document Formula Fields: Deprecation of Non-State FieldsAuto-on25R1.2

With the availability of Cycle Time Functions to support process reporting functionality in document report formula fields, any existing configured document formula fields that do not use Document Status or State Type will begin returning blanks. Existing formula fields that use Document Status or State Type will continue to function as expected.

Support Last Modified By & Created By in FormulasAuto-on25R1.2

Last Modified By and Created By fields can now be leveraged in formula expressions, like any other User reference field. Prior to 25R2, these two fields were not available for selection in any Vault formula editor. They can now be used in the following areas for Objects:

• Validation Rules
• Formula Fields
• Field Defaults

You can use these fields in combination with existing functions. For example, Id(created_by__v) would return the ID of the user in the Created By field.

Learn more about Creating Formulas in Vault.

Enhanced Document Picklists in FormulasAuto-on25R1.2

Document picklist fields now return the name of picklist values instead of the labels in lifecycle and workflow formulas. This behavior is now consistent with object picklist fields and document picklist fields in reports. Existing uses of document picklists in lifecycle and workflow formulas will be wrapped in the Text() function, which returns the labels and preserves current behavior.

Prior to this feature, the inconsistent behavior of document picklists across Vault formulas and the inconsistency between object and document picklists within lifecycle and workflow formulas caused confusion for users.

Learn more about Creating Formulas in Vault.

Admin Experience

Direct Data API: Admin EnablementAdmin Checkbox25R1.3

Admins can now enable Direct Data API in Admin > Settings > General Settings without opening a support ticket. This enablement is one-way, hence you cannot revert it once it is enabled.

Object Reference Field DefaultConfiguration25R1.3

We have expanded the way Admins can default object field values by replacing the related record field selector with an expression editor on Object > Field > Default Value.

Defaulting via Related Record Field (Outbound)

By clicking the auto-complete token button next to the expression editor, you can browse between outbound object relationships and select any field that is configured for the same object, similar to previous functionality. Fields from outbound relationships are supported up to three (3) levels away.

Defaulting via RecordByUniqueField() Function

If the object record you are trying to set as default is not based on a relationship, you can use the RecordByUniqueField() function to identify any object record by its unique field value.

Here is an example to set the Region object field to default based on the country selected.

IF( country__cr.name__v = "USA", RecordByUniqueField($region__c, {$name__v:"North America"}), RecordByUniqueField($region__c, {$name__v:"Other"}) )

We also provided a user-friendly formula helper for the RecordByUniqueField() function to make writing the formula easier. Click on the Records tab above the expression editor to open a dialog where you can select the appropriate parameters from a dropdown list. Your selections will insert the formula into the expression editor with the correct parameters.

Learn more about Setting Object Field Defaults.

Support for Flash Report Configuration MigrationAuto-on25R1.3

Admins can now migrate flash reports across environments using configuration migration packages, reducing effort in having to reschedule reports post-migration. Prior to 25R2, it was not possible to migrate flash reports while maintaining the associated schedule as the associated job was not available to be migrated.

When including flash reports in a configuration migration package going forward, Admins can include the associated job:

The job is also shown as a dependency when using the View/Add Dependencies option.

If the Runs As user is unavailable in the target Vault, the migrating user is set as the Runs As user of the flash report. If a flash report is migrated and the related job is not, the report is migrated as a regular report.

Learn more about Flash Reports.

Include Collaborative Authoring Settings in Sandbox RefreshesAuto-on25R1.3

When a Vault is refreshed from another Vault with a verified connection using the modern collaborative authoring configuration (without the Collaboration User), then the collaborative authoring configuration is maintained as part of the refresh. This reduces effort for Admins because prior to 25R2, or when using the legacy collaborative authoring configuration, the collaborative authoring connection would need to be set up and reverified with each refresh.

All customers must update the collaborative authoring configuration to the modern method by the 26R1 release; however, updating the configuration sooner means that Admins will have a smoother sandbox refresh experience.

Vault Loader Enhancements for Object Record Create, Update, Delete OperationsAuto-on25R1.2

The response returned in Loader logs for Upsert, Update, and Delete object operations is enhanced to provide additional information with the response:

• If a Key Value (idParam) was provided, the corresponding value for the field specified will be included within the response in the id_param_value column.
• If an Upsert was requested using a Key Value (idParam), the record level outcome (Create or Update) will be included on the response.

Enable Inbound & Outbound Package Settings for All VaultsAuto-on25R1.2

Prior to this release, customers had to manually enable Inbound and Outbound packages with an Admin setting. With this release, Inbound and Outbound packages are enabled by default, and the previous Admin setting to manage this functionality has been removed.

Vault Tokens in ExpressionsConfiguration25R1.3

Vault now supports using Vault tokens in formulas. Prior to 25R2, only Domain, Timezone, and Vault ID could be accessed using the @Vault system variable. Admins can now return additional standard tokens and can include custom tokens in Vault formulas.

By default, Admins can leverage the following standard Vault tokens in formulas:

• Domain
• Timezone
• Vault DNS
• Vault ID
• Vault Name

These tokens can be leveraged in the following areas:

• Objects:
  • Validation rules
  • Formula fields
  • Field defaults
  • Layout rules
• Workflows and lifecycle conditions for both documents and objects
• Report formula fields

Additionally, Admins can configure custom Vault tokens in Admin > Configuration > Vault Tokens:

These custom tokens are also available in formulas:

Learn more about Creating Formulas in Vault and Vault Tokens.

Jobs: Timeout StatusesAuto-on25R1.3

To accurately represent the status of jobs, the following new job statuses are now available:

• Timeout indicates if the queuing job has timed out.
• Completed due to Inactivity indicates if a running job timed out.

Cancel a Job in Queued or Queueing StateAuto-on25R1.3

Admins can now cancel individual queued or queueing job instances that are eligible for cancellation:

• Custom date-based document and object operation jobs

• Custom SDK jobs that have been specified to be cancellable

• Standard and application-specific jobs that the application team have specified to be cancellable

Previously, Admins could not cancel queued jobs without creating a support ticket. Eligible jobs can be cancelled individually on the Operations > Job Status page. Jobs in the Running state cannot be cancelled.

Vault Loader: Capture Use of No TriggersAuto-on25R1.3

We will be capturing whether the No Triggers flag was used with Record Migration Mode in the Job Details and the Notifications.

Minor Enhancements

Object Reference Field Item LimitAuto-on25R1.2

When selecting object records in a field on a document, there is an existing limit of 250 records that can be selected. Prior to 25R2, this limit was not enforced when using Select All from the record select dialog box. Going forward, this limit will be enforced in all cases, when selecting records individually or when using Select All.

Document Viewer: Updated Keyboard Shortcuts for ZoomAuto-on25R1.3

When working in the document viewer, the keyboard shortcuts to zoom in and zoom out have been updated as follows:

Windows:

• Zoom In: Shift + Ctrl + + (Shift + Ctrl + plus)
• Zoom Out: Shift + Ctrl + - (Shift + Ctrl + minus)

Mac:

• Zoom In: Shift + Cmd + + (Shift + Cmd + plus)
• Zoom Out: Shift + Cmd + - (Shift + Cmd + minus)

Prior to 25R2, the shortcuts did not include Shift, which could cause conflicts with browser shortcuts.

Learn more about Vault Keyboard Shortcuts.

Disable Manual Bring Forward Annotations Until Document Processing is CompleteAuto-on25R1.3

When manually bringing forward annotations from a prior version, the Bring Forward Annotations button is now disabled until Optical Character Recognition (OCR) is complete.

If OCR is not complete when annotations are brought forward, then text would not be recognized for Vault to appropriately place the brought-forward annotations. This enhancement helps reduce the potential for page-level annotations.

Users do not need to refresh the page; the Bring Forward Annotations button is automatically enabled once OCR is complete.

Additionally, the button remains disabled if OCR is complete but annotations are in the process of being automatically brought forward.

Increase Copy Text Selection Limit to 500 WordsAuto-on25R1.3

When copying text from a document in the document viewer, users can now select and copy up to 500 words. Prior to 25R2, this was limited to 200 words. This enhancement provides greater flexibility to users and supports application-specific functionality such as Health Authority Question extraction in Veeva RIM.

Learn more about Copy Text.

Vault File Manager: Improved Clear Button on Uploads & Downloads TabsAuto-on25R1.2

When using the Clear button on Vault File Manager’s Uploads and Downloads tabs, all documents in the following statuses are now removed:

• Complete
• Failed
• Corrupted
• File Not Found
• Cancelled

Prior to 25R2, only Complete or Cancelled documents were removed, and any other documents would need to be individually removed.

This enhancement makes it easier for Admins to clean up and remove errors within Vault File Manager, and is particularly helpful in cases where hundreds or thousands of files are being uploaded or downloaded.

Learn more about Accessing Your File Staging Server in Vault File Manager.

Enhanced Duplicate Attachment DetectionAuto-on25R1.3

This update prevents the upload of new attachments that share the exact filename of an existing attachment with an MD5 checksum that has not yet been calculated. This safeguard ensures file uniqueness and data consistency.

Automatic Mentioning in Collaborative Authoring: Updated Messages in CSVAuto-on25R1.3

When using automatic mentioning in collaborative authoring, users now see updated wording in the optional CSV notification. To more accurately reflect the interaction between Vault and Office 365 in the Check Out to Collaborative Authoring workflow action, the messages in the optional CSV notification are updated to reflect that Vault specifically grants Edit permission to the document on SharePoint.

Prior to 25R2, the CSV message stated that a user was granted the ability to be @ mentioned; this is not always the case, depending upon the Microsoft tenant settings, or if the user is an external user.

This feature does not change behavior for users, but makes the messaging of the success and failure messages more clear.

Learn more About Notifications for Collaborative Authoring Workflow Actions.

Collaborative Authoring Error Log: Expanded LoggingAuto-on25R1.3

The Collaborative Authoring Error Log now displays all errors returned by Microsoft Graph API relating to checking out and checking in collaborative authoring documents. Previously, only errors relating to uploading files during check out and deleting files during check in were displayed in the log.

System Audit Logs: Display Record Labels in Field Dependency ChangesAuto-on25R1.2

When creating or editing a document field dependency set to Controlled by Document Field and the condition references object records, the System Audit History now identifies the records by label instead of ID. This enhancement makes it easier to identify specific changes in the audit log without needing to look up records by ID.

As an example, this field dependency is set to Controlled by Document Field for the Project object reference field:

Project 1 is selected for the field dependency itself:

The System Audit History now displays the specific record label Project 1 instead of the record ID:

Learn more about Managing Dependent Fields.

Prior Person: Lock Format Mask for First Name, Last Name & User Name fieldsimages25R1.2

Admins can no longer configure format masks for First Name, Last Name and User Name fields on the Prior Person object.

Vault Connections

CTMS - EDC

Clinical Operations-EDC: Automatic Procedure Definitions AlignmentConfiguration25R1.2

Currently, users are required to manually create and map Procedure Definitions in both Clinical Operations and EDC Vaults to enable the Clinical Operations-EDC Connection’s Procedure integration. This feature automates this process by leveraging the Procedure Definitions in EDC to automatically create or update corresponding Procedure Definitions in Clinical Operations. The connection does not remove Procedure Definitions in CTMS if the corresponding configuration in EDC is removed. Users can continue to create Procedure Definitions in CTMS as needed, for example, to set up automated payments.

The new Procedure Definition integration point will be active by default upon release. This change does not impact customers who do not use the Clinical Operations-EDC Connection for Procedures (i.e., Procedure integration is inactive). For customers with an active Procedure integration, the connection will begin creating Procedure Definitions in CTMS as needed, starting with the next update to a Procedure Definition in EDC. Existing Procedure Definitions will be ignored.

This enhancement aligns the connection’s handling of Procedure Definitions with its management of Visit Definitions, ensuring a consistent approach to metadata management between EDC and CTMS across systems. Additionally, the automation introduced streamlines and simplifies processes by eliminating manual effort and reducing the risk of errors.

CTMS Visit Definition to Visit Group RelationshipConfiguration25R1.3

Currently, the Clinical Operations-EDC Connection automatically brings Visit Group Definitions and Visit Definitions into CTMS from the EDC system without any explicit connection between them within CTMS.

This feature now enhances the Clinical Operations-EDC Connection to create and manage direct relationships between Visit Definitions and Visit Group Definitions within CTMS. This is achieved through a new object and a dedicated integration point that automatically establishes these links based on the corresponding relationships in EDC. For each related pair found in EDC, the system will either update an existing record in CTMS or create a new one. If a matching Visit Definition or Visit Group Definition is missing in CTMS, a user exception message is generated. The new integration point is delivered as Inactive.

This enhancement provides a more detailed and accurate representation of study visit structures in CTMS, leading to better management and alignment with study protocols.

eTMF-EDC

Clinical Operations-EDC: Final CRFsConfiguration25R1.3

This feature enhances the Clinical Operations-EDC Connection by automating the transfer of final Case Report Files (CRFs) from Veeva EDC to Veeva eTMF. This automation streamlines the process, reducing the manual effort previously needed to transfer CRFs. Sponsors benefit from the automatic storage of CRFs as documents (one PDF per subject) in Veeva eTMF. The feature also supports automatic updates of Final CRF TMF Documents when CRF files are regenerated in Veeva EDC. This enhancement allows for more efficient handling of study closeout documents and facilitates the ability to send CRFs from Veeva eTMF to sites via SiteConnect. The connection logic verifies study connection status (Connected to Vault CTMS in EDC), Study pause status, and the new CRF Transfer integration’s active state. Target documents are created, populating fields such as the study (study__v), study country (country__v), site (site__v), and document title. The document title is populated with the subject name as provided in the source document. Document versioning is aligned with the source CRF version. This enhancement, that requires configuration, simplifies the management of study closeout documents.

PromoMats - Medical

PromoMats-Medical: Auto Update Anchor SupportConfiguration25R1.3

Connection created anchors are available on the Crosslinks’ draft state before the Crosslink is moved to steady state. This enhancement supports the Update Claims Reference Anchors steady state entry action to ensure text assets using Reference Crosslinks are up to date.

Quality-RIM

Quality-RIM Connection: Event Auto-Create Per Change Control / Product FamilyConfiguration25R1.3

This release builds upon the Quality-RIM Connection’s Enhanced Change Control feature, automating Event creation with greater precision. You can now automatically create a unique Event for each Change Control and Product Family combination.

Streamlined Event Management

The Quality-RIM: Change Item to Event and Event Change Item integration point has been updated to enable the creation of distinct events based on the specific pairing of a Change Control and Product Family. This provides a more granular and organized approach to event management.

Key Benefits

• Granular Event Tracking: Automatically create separate events for each Change Control/Product Family combination, enabling more precise tracking and management of quality-related activities.
• Improved Efficiency: Reduce manual effort and streamline workflows by automating event creation, saving valuable time and resources.
• Enhanced Data Integrity: Ensure accurate event records by automatically linking events to the relevant Change Control and Product Family.
• Expanded Applicability: This enhancement is available for QMS customers using either the standalone Change Control object or the legacy Quality Event object (Change Control type).

Important Information

• Vault Compatibility: This feature is compatible with any RIM and any Quality Vault. It iis not restricted to Registrations and QMS, as with the Quality-RIM Variation Management feature.
• Configuration Required: Feature enablement requires specific configuration.

This enhancement empowers you to automate event creation with increased accuracy and efficiency, providing a more robust and streamlined approach to Quality Event management.

Quality-RIM Connection: Product Data EnhancementsAuto-on25R1.3

The Veeva RIM application is the source of product data for Vault applications, including Veeva Quality applications. The Quality-RIM Connection includes the Product Transfer feature, which helps an organization keep its Quality Vault’s product data synchronized with its RIM Vault. It copies a RIM Vault’s Product Family, Product, and Product Variant records to the connected Quality Vault. If the Product records do not exist in the Quality Vault, the connection creates them. The connection updates the Quality Vault’s Product records when changes are made to data fields on product records in the RIM Vault.

Some organizations manage master product data outside of Vault in an external system and build custom integrations to push product data from the external system directly into their Vaults. This feature addresses a specific situation when external systems create Product records in RIM and Quality Vaults and use the Quality-RIM Connection to synchronize their Quality Vault’s product data with product data in their RIM Vault.

More specifically, the Product Data Enhancements feature allows the connection to know if Product records coming from RIM already exist in Quality. This is accomplished by using a new External ID field on Product records. When an external system integration creates a Product record in each Vault, it must assign a unique identifier to the record’s External ID field. If the connection determines that a RIM Product record’s External ID value matches the External ID value in a Quality Vault’s Product record, it knows the two Product records are a match and links them. If any of the corresponding Product record fields differ between the matched RIM and Quality Product records, the connection updates the Quality Product record fields to keep them synchronized with RIM. When the external system integration creates Product records in Quality, it must check that a record doesn’t already exist with that External ID so that a duplicate isn’t created.

This feature is automatically enabled in all customer Quality Vaults as a result of the 25R2 release. Learn more about the Product Transfer feature in the Quality-RIM Connection.

Quality-Safety

Quality-Safety Connection: Create Safety Inbox Items from Veeva QualityConfiguration25R1.3

The 25R1 release introduced the validated Vault-to-Vault (V2V) Quality-Safety Connection.

This release builds on the Quality-Safety Connection by introducing the Create Safety Inbox Items from Veeva Quality feature. This feature helps organizations close the loop on the Safety PQC process by enabling Quality to send investigation outcomes for Complaints that originate in Safety back to the Safety Intake Team. Closing the Quality-Safety loop is critical for PQC follow-up and reporting activities.

The Quality organization can also receive PQCs containing potential adverse events. This feature enables Quality to send PQCs originating in Quality to Safety, allowing them to be triaged by the Safety Intake Team for potential adverse events.

Organizations send information about a Quality Vault’s Complaint record using an entry action, a user action, or a system action. The Quality-Safety Connection automatically creates one Inbox Item record in the Safety Vault for each Complaint record received from a Quality Vault. If the Quality Complaint record includes a Safety Case Number, the Inbox Item created is linked to the original Safety Case record because it is considered a follow-up. Otherwise, if the Quality Complaint record does not include a Safety Case Number, the Inbox Item record created is net-new. Upon successful creation of a Safety Inbox Item record, the Quality-Safety Connection also updates the Quality Complaint record with the ID of the Safety Inbox Item for traceability.

This feature supports the standalone Complaint object and the Complaint object type for the Quality Event object. Deploying this feature requires configuration by a system administrator.

Learn more about the Quality-Safety Connection, including the standard field mappings that transfer data from a Quality Complaint record to a Safety Inbox Item record.

RIM-Clinical Operations

RIM-Clinical Operations: Regulatory Tracking for Clinical Trialsimages25R1.3

Regulatory tracking for initial clinical trial approval is managed in RIM, but it is Study Start Up teams that manage clinical trial milestones and need insight into submission dates and verdicts in order to initiate study activities. Today, tracking of the same fields is done in two systems - RIM and Clinical, and customers need a way to avoid double-entry of data and the data integrity issues that can arise as a result. A new integration between RIM Vault and Clinical Operations Vault will send relevant regulatory tracking information for initial clinical trial approvals from various RIM objects, including Regulatory Objective and Country Decision Detail, to Clinical milestones via the RIM-Clinical Operations Connection.

This feature will support the transfer of dates for initial global clinical trial approval procedures, such as US INDs, Canadian CTAs, and EU CTR.

Key Benefits:

• Eliminate Double Data Entry: Reduce manual effort and free up valuable time for Study Start Up teams.
• Improve Data Accuracy and Integrity: Ensure clinical teams are working with the latest and most reliable regulatory approval information.
• Streamline Study Start Up: Accelerate the initiation of clinical trial activities by providing timely access to critical dates.
• Enhance Collaboration: Foster better communication and alignment between regulatory and clinical operations teams.
• Reduce Risk of Delays: Proactively manage study timelines with accurate and readily available approval information.

Enablement: Configuration will be required in both RIM and Clinical to activate integrations, fields, picklists, values, and lifecycles.

RIM-Clinical Operations: Update to CrossLink Behavior to Respect Sitesimages25R1.3

We’ve implemented a significant improvement to how CrossLinks from RIM are handled in Clinical Operations vaults, ensuring greater data accuracy and consistency between systems.

Key Change: CrossLinks originating in RIM will intelligently recognize and respect site information populated on the RIM source document, and if the site does not exist in Clinical, a User Exception Message will be generated and a CrossLink will not be created or updated.

Impact:

• Improved Data Alignment: If a site is specified on the document in RIM, the corresponding CrossLink in Clinical will now be correctly associated with that specific site.
• Prevented Misfiling: Previously, if a site from RIM didn’t exist in Clinical, the CrossLink would be incorrectly filed at the study level, potentially leading to data discrepancies. This issue has been resolved.

This update streamlines data management and significantly enhances the reliability of CrossLinks between RIM and Clinical Operations.

Safety-Clinical Operations

Safety-ClinOps Enhanced Error HandlingAuto-on25R1.3

It is crucial to optimize the handling of failed records to ensure the Safety-Clinical Operations connection efficiently processes data and minimizes unnecessary resource consumption. Previously, a single record failure caused the failure of an entire batch. Also, there was no reprocess action. Combination of both can lead to resource load in extreme cases and pose challenges for customers with high data volumes and delays in getting data in the downstream system.

This new feature introduces a more efficient processing mechanism for the Safety-Clinical Operations connection. First, the connection now maintains records of the Last Successful Run Time (LSRT) and Last Run Time (LRT) for each integration point, providing better visibility into data processing. Also, the connection is also able to automatically reprocess failures.

This enhancement is auto-enabled for all Safety-Clinical Operations Connection customers, enabling faster, more efficient, and resource-conscious data integration.

Safety-EDC

Safety-EDC Connection: Configurable Significance RulesConfiguration25R1.3

With this release, Admins can configure significance rules for Inbox Items imported via the Safety-EDC Connection. This enables the customization and management of how Vault identifies significant and urgent significant Inbox Items. Key enhancements include:

• Introduction of the Significance Criteria object to manage rules tied to specific fields and objects.
• A Significance Criteria Builder to simplify the creation of rule expressions.
• Introduction of the Significance Result object within Inbox Items, helping users understand which rules influenced the Inbox Item’s significance status.
• Support for new expression functions, including:
  • VS_CHANGED: Detects changes between new Inbox Items and existing Cases.
  • VS_NEW: Identifies new records in incoming Inbox Items compared to existing Cases.

Learn more about configuring Significance Criteria for Inbox Items generated by the Safety-EDC Connection.

Safety-EDC Connection: Safety Case Follow-Ups Honor Safety DecisionsAuto-on25R1.3

The Safety-EDC Connection now supports seamless communication and traceability of Safety decisions between Vaults. This ensures that decisions initiated within Safety are not only shared with EDC but are also actively tracked for any relevant updates that occur downstream.

When users select subject-related information by running the Add Relevant Subject Information action, Vault generates a formal Safety decision. This decision is automatically transmitted to the EDC Vault, where it becomes associated with the corresponding subject’s data.

Once Vault sends the Safety decision to EDC, the Vault continuously monitors any subsequent changes or updates to the associated EDC Form Safety Case information. If users modify relevant data in EDC after the Safety decision is received, Vault sends a follow-up back to the Safety Vault. This ensures that Safety teams are promptly notified of any developments, supporting ongoing case evaluation and regulatory compliance.

A Case in a Safety Vault can contain several events split into individual Cases or Cases are merged to a single Case. While EDC clinical data and site linking decisions remain unchanged in this release, decisions taken on the Safety side to add, remove, spit, and or merge are honored when Vault compiles the next update from EDC. This includes the protection of an added concomitant medication on Safety side, and guarantees that the Case receives a follow-up if changes are made to the associated Concomitant Medication form, which is not linked by the site in EDC and would have been ignored by the connection in previous releases.

This enhanced, closed-loop workflow reinforces data consistency between Vaults, improves decision tracking, and ensures that Safety personnel are always working with the most up-to-date information when managing subject Cases.

When testing this feature, allow ten (10) minutes for Safety decisions to reflect in EDC before triggering an ad-hoc follow-up.

Learn more about how the Safety-EDC Connection honors Safety decisions.

Safety-EDC Connection: EnhancementsAuto-on25R1.3

With this release, Veeva Safety introduces several improvements to the Safety-EDC Connection, including:

• Label Update: The CDMS Subject Information field on the Inbox Item and Case Version objects is now labelled EDC Subject Information for better alignment with terminology.
• Decimal Truncation Handling: EDC number fields exceeding the decimal precision of the Safety data model are now truncated, and Vault generates a warning User Exception Item. Previously, this would prevent records from saving.
• Duplicate Global ID Management: Vault ignores duplicate global IDs Case Product Dosages or Event Product Assessments. Vault generates a warning User Exception Item to alert users when failures occur due to duplicate Case Product Dosages or Event Product Assessments for a specific subject.

Learn more about the Safety-EDC Connection.

Clinical Operations

Several features in the Vault Connections section also apply to the Clinical Operations application family.

All Clinical Operations

Specialized Responsibility Support in Veeva ClinicalConfiguration25R1.3

To ensure comprehensive and tailored training for site staff involved in clinical studies, it’s essential that training assignments accurately reflect their specific duties. The Study Person Responsibilities feature, introduced in the 24R2 release, provided a standardized list of responsibilities to facilitate Responsibility-based training in Study Training. This standard list, managed by Veeva, represented the industry best-practice. 

Specialized Responsibilities provide flexibility in managing study-specific training for site staff. Customers can now define and manage a limited number of additional specialized responsibilities alongside the standard responsibilities maintained by Veeva.

By allowing for the inclusion of specialized responsibilities, organizations can ensure that site staff are trained precisely on their required tasks, minimizing unnecessary over-training and ultimately improving the efficiency and effectiveness of clinical study operations.

Enhanced Study Person Responsibility Selection DialogAuto-on25R1.3

The responsibility selection dialog for Study Personnel has been updated to list Study Responsibilities. It lists Study Responsibilities and visually groups Specialized Responsibilities under their Standard Responsibility.

Study Responsibilities are responsibilities assigned to the Study.

Subartifact Support for Create Related Document from Template System ActionConfiguration25R1.3

The Create Related Document from Template system action will now support Clinical Subarifacts. Admins can optionally add the Subartifact to the system action and the Subartifact document field will populate when the system generates the document. Only Subartifacts mapped to the selected Document Type will be available to select.

The Enable Subartifacts application setting must be enabled to leverage this capability.

The Create Related Document from Template system action is used to generate Monitoring Event Confirmation Letters, Follow-up Letters, and Payment Letters to name a few.

Generate Document from Formatted OutputConfiguration25R1.3

Clinical Operations supports a new record action, Generate Document from Formatted Output, that is available as an entry action or user action on all object lifecycles. The action generates a library document based on a specified Formatted Output Template and document Classification. When configured on the Site Survey or Outreach Target Survey object lifecycles, it includes an additional setting, Send Copy to Survey Respondent, which is used to send a copy of the generated document to the survey respondent for the Completed Survey Notification and Electronic CDA features.

This action does not support up-versioning the previously created document when executed multiple times. The execution of the action will create a new document every time.

Protocol Deviation Categories & Subcategory Transfer EnhancementsConfiguration25R1.3

Accurate categorization of protocol deviations is critical in the pharmaceutical and clinical research industries. It ensures consistent data collection, facilitates trend analysis, and enables effective risk management, ultimately contributing to patient safety and data integrity. However, the current approach to managing Categories and Subcategories for protocol deviations presents challenges with CTMS Transfer. Due to the lack of granularity in the standard, these categories/subcategories are often highly customized to meet specific organization needs, which adds significant complexity to the mapping process during data transfer. This complexity arises because the inherent Category > Subcategory relationship established through customization in the source Veeva CTMS is not easily maintained with the transfer. Consequently, mapping these custom entries in the target CTMS can be time-consuming, resource-intensive, and prone to errors, potentially hindering the seamless sharing of crucial study data.

To directly address these challenges and streamline the transfer of protocol deviations, the 25R2 release introduces the following enhancements:

• We add a new standard Other subcategory. This provides a designated option for mapping custom subcategory values originating from the source Veeva CTMS that do not have a direct counterpart in the target system.
• We provision two (2) new text fields on the target Issue record: Source Category and Source Subcategory. Upon transfer, these fields will be automatically populated with the verbatim labels of the Category and Subcategory values from the source Protocol Deviation. This provides valuable context regarding the origin of the deviation, especially when custom values are involved. 

Please note that Issues utilizing custom, unmapped Categories or Subcategories will continue to not transfer and will generate an error, reinforcing the importance of accurate mapping for custom configurations.

These enhancements will significantly simplify the CTMS transfer process for protocol deviations, especially in environments with highly customized category and subcategory structures, ultimately leading to more efficient and accurate data transfer.

Bulk Update Study Migration StatusAuto-on25R1.3

Vault’s Migration Mode has been significantly improved to streamline large-scale data migration processes. Previously, administrators needed to manually adjust Migration Mode settings for each individual Study using Vault UI, a time-consuming task, especially for extensive migration projects.

With this update, administrators can now efficiently manage Migration Mode settings for multiple Studies at once using a single API call. This bulk update capability significantly reduces the time it takes to set studies in or out of migration mode, a step often bound by a time window, allowing for faster and more efficient data migration.

Selective Ad Hoc EventsAdmin Checkbox25R1.3

This feature introduces a new capability for Ad Hoc Events that allows an initiator to select the Study Countries and Study Sites applicable to a given event so that Milestones and Expected Documents are created for only the selected records. Additionally, it provides the option to specify a Version Name for each Ad Hoc Event so the resulting milestones can be identified by their Version Name. 

Upon initiation of an Ad Hoc Event, a user will select a Story Event and can optionally specify a Version Name. Upon continuation, if the Story Event contains Template Milestone Sets at lower levels, a new modal appears to allow for the selection of applicable Study Countries and/or Study Sites. Once the selections are reviewed and confirmed, the system will generate Milestones and Expected Documents based on those selections and name all instantiated Milestones with the appended Version Name.

A new application setting, Enable Selective Ad Hoc Events, must be enabled to leverage the feature.

Alphabetize Story EventsAuto-on25R1.3

The system will now sort the list of Story Events alphabetically when an Ad Hoc Event is initiated. The feature will be automatically applied to all Clinical Operations Vaults on release night.

Content Defaulting RefactorConfiguration25R1.3

This feature introduces new elements to default the Content (blinding__v) field on documents more accurately to reduce the effort on end users managing blinding in the TMF. A new application setting, Enable Enhanced Blinding Defaulting, must be enabled to leverage the new feature capabilities. 

Content defaulting now considers whether the Study is blinded through the Masking (masking__v) Study field. Studies with Open Label populated in the Masking field will default all documents to Blinded. Whereas, Studies that have the Single Blinded or Double Blinded value in the Masking field will not automatically default the document Content field based on Masking.

If the Study does not track masking or the Masking field is set to Single or Double Blinded, the system will look to the new Document Type Group, Unblinded (unblinded__v), that can be defined on the document type level. For documents that can have unblinded content, the Unblinded Document Type Group can be applied to ensure that if the user uploading the document can upload unblinded content that the system defaults the document’s Content field to Unblinded. If the document type does not have the Unblinded document type group applied, then the document will be defaulted to Blinded content, regardless of the uploader’s privileges.

The Content document field will not be overridden by this new defaulting capability when a document is created via API or with a Vault Connection if the source document has a blinding value. If the Content field is blank, the system will default based on the new defaulting behavior.

Additionally, this release is updating how the content field is updated during reclassification. Now, when the document is reclassified or fields, like the Study, Study Country or Study Site, are changed the system will not update the Content field as it previously had. This change to content updates during reclassification is automatically turned on with the release. Customers can request this to be turned off if the previous behavior is desired.

"Available as Study Site" Field on OrganizationConfiguration25R1.3

This feature introduces a new Available as Study Site field on the Organization object in all Clinical Operations Vaults. When activated, only Organizations with this field set to TRUE can be selected as Study Sites, ensuring proper Global Directory record usage.

This field is provisioned as inactive unless OpenData Clinical (ODC) is enabled, in which case it is provisioned as active.

This enhancement allows users to clearly distinguish between parent Organizations and the specific departments or locations that function as actual Study Sites. While the Available as Study Site control is generally available, it is a required component for ODC records.

CTMS

CTMS Licensing: Enrollment Metrics TrackingAuto-on25R1.2

CTMS license tracking in the Study Site License object now includes Enrollment Metrics. A Study Site is now considered to be consuming a CTMS license if it has at least one Monitoring Event, Issue, or Metric record with an Actual value greater than zero.

Admin can view license consumption in the Vault About page. Users will see a warning message if consumption is over the licensed amount.

CTMS Transfer - Oversight Issues from Sponsor to CROConfiguration25R1.3

In fully outsourced studies, sponsors can receive study data directly from their Clinical Research Organizations (CROs) daily via CTMS Transfer, enabling trial management oversight in their own systems. A critical part of this oversight involves sponsors raising Oversight Issues against the transferred CTMS data (e.g., Monitoring Events, Milestones, and Issue records). Timely communication of these issues to the CRO is crucial for prompt corrective action. Currently, this communication typically relies on inefficient methods such as emails, meetings, and separate sharing of information from Veeva CTMS or other trackers, leading to potential delays and miscommunication.

To accelerate and simplify this data exchange, CTMS Transfer is enhanced to be bi-directional, now supporting the transfer of Oversight Issues. Leveraging the existing study transfer agreement, Oversight Issues tracked in the Sponsor Veeva CTMS (the source of truth) will now be transferred directly to the CRO Veeva CTMS. Once the CRO corrects the source data or takes action to address the oversight issue, the sponsor can then close out the Oversight Issue in their Veeva CTMS. 

This enhancement provides a streamlined, automated way to inform CROs of oversight issues and facilitate their resolution, improving the speed and accuracy of issue management.

Last Subject Milestones: Earlier Last Subject Screened PopulationAuto-on25R1.3

This feature enhances Automated Enrollment Milestone behavior for Last Subject Milestones.

When the No New Subjects field on a Study Site is checked, Vault automatically populates the Actual Finish Date on Last Subject-related milestones based on specific criteria. To accommodate protocol designs with a gap between screening and enrollment, we have updated these criteria to allow for more granular tracking of milestone completion. Now, when the Last Subject is screened at a Study Site, users can check the No New Subjects field to update the Last Subject Screened and Last Subject Consented Milestones. The Last Subject In, Last Subject Randomized, and Last Subject Started Treatment Milestones are only populated when the following additional criteria are met: 

Milestone Type	Auto-Populated Value
Last Subject In	The latest Enrolled Date of the Subject if all Subjects for the Study Site have either: A Subject Status of Screen Failure, Enrolled, or Withdrawn A value in the Screen Failed Date, Enrolled Date, or Withdrawn Date
Last Subject Randomized	The latest Randomized Date of the Subject if all Subjects for the Study Site have either: A Subject Status of Screen Failure, Randomized, or Withdrawn A value in the Screen Failed Date, Randomized Date, or Withdrawn Date
Last Subject Started Treatment	The latest Started Treatment Date of the Subject if all Subjects for the Study Site have either: A Subject Status of Screen Failure, Started Treatment, or Withdrawn A value in the Screen Failed Date, Started Treatment Date, or Withdrawn Date

This feature is auto-on for Vaults with Enable Automated Enrollment Milestones enabled.

Last Subject Milestones: Incomplete Subject Status DatesConfiguration25R1.3

This feature adds a new Incomplete Subject Status Dates field to the Subject object. When this field is set to Yes for a Subject, any blank Subject Date fields are excluded from Automated Enrollment Milestones behavior. For example, if a Study Site has three Subjects, two of which have Enrolled Dates populated and one of which has a Subject status of In Screening and no Enrolled Date, Vault does not populate the Last Subject In Milestone since all criteria have not been met. However, if the Subject with the status of In Screening also has the Incomplete Subject Status Dates field marked as Yes, Vault does autopopulate the Last Subject In Milestone. 

The Incomplete Subject Status Dates field is provisioned as inactive. When this field is inactive, it is not evaluated and there is no change to the Automated Enrollment Milestone behavior. 

This new field provides greater flexibility in managing milestone completion when Subject data is incomplete.

Last Subject Milestones: Preferred End of Treatment DateAuto-on25R1.3

This feature updates the Automated Enrollment Milestones completion criteria for the Last Subject Treated Milestone. Previously, Vault populated the Last Subject Treated Milestone Actual Finish Date using the latest End of Treatment Date or Withdrawn Date of the Subjects at the Site. Now, Vault uses the latest Withdrawn Date only if no Subjects have an End of Treatment Date populated. Otherwise, Vault uses the latest End of Treatment Date. 

This feature is auto-on for Vaults with Enable Automated Enrollment Milestones enabled.

Prevent User Updates to Date-Based Metric Actual Removed from Vault SettingsAuto-on25R1.3

In 24R2, we introduced a feature locking the Actual field on Metrics records from being edited by users for Date-Based Studies. A temporary opt-out setting was included to allow customers time to adjust. This setting has now been removed, meaning the Actual field on Metrics records is no longer editable by users in all Vaults where the Study Metric Calculation is set to Date-Based.

Recruitment Planning: Consistency & Error Handling ImprovementsAuto-on25R1.3

Subject Recruitment Planning allows users to plan subject recruitment metrics (screened, enrolled, randomized) over time. The Create Metrics Over Time action generates these records for the Study, Study Country, Study Site, and Subject Group as applicable based on Study design.

This feature includes the following enhancements for Create Metrics Over Time consistency and error handling:

• Success or failure notifications and job log details
• Handling of duplicate Metrics records
• Re-creating subject recruitment plan with planned values when Milestone dates do not overlap with the original range when the Create Metrics Over Time action was initially run
• Respect Metrics Not In Use and Global Subject Metric Enablement status
• Default to use Subject Group milestones if non-Subject Group milestones at the appropriate level and type are not found

Subartifact Support for Create Trip Report System ActionAuto-on25R1.3

The Create Trip Report system action that supports creating Trip Report documents from a Monitoring Event will now support Clinical Subartifacts. Admins can optionally add the Subartifact to the system action and the Subartifact document field will populate when the system generates the Trip Report document. Only Subartifacts mapped to the selected Document Classification will be available to select.

The Enable Subartifacts application setting must be enabled to leverage this capability.

Subject Transfer Support for Seeding Subject Visits on Monitoring EventsAuto-on25R1.3

This feature enhances the Seed Monitored Enrollment and Proactively Seed Monitored Enrollment actions, used in Monitoring Events, to support subject transfer scenarios. With this update, the subject visits seeded into a Monitoring Event are limited to visits at the Subject’s current Study Site.

eTMF

Multilingual ModelsSupport25R1.3

As clinical trials operate on a global scale, and a significant portion of TMF documents are written in languages other than English: it’s not uncommon for Sponsors or CROs to have more than 50% of their TMF documents in non-English languages. To date, the TMF Bot could only train on and auto-classify documents with English text.

To significantly expand the TMF Bot’s coverage, we are introducing the Multilingual Models feature. This enhancement enables the TMF Bot to train on and automatically classify and/or detect key metadata in documents that are in non-English languages. More than 30 languages are supported.

Study Document Audit Trail ExportConfiguration25R1.3

This feature allows users to export a Study’s full audit trail for documents through a user action on the Study’s lifecycle. The new system action, Export Full Study Audit Trail, will first prompt the initiator for an optional date range and then generate a consolidated CSV file. The system will default the Start Date to 30 days before today. If no date range is selected, the full Study document audit trail will be exported. 

Deleted Study documents are included in the document audit trail export. A system notification and an email will be sent when the CSV file has been generated.

eTMF License CalculationAuto-on25R1.3

This feature introduces a new method for calculating eTMF Study Site licenses. The system now determines eTMF license consumption based on the presence of documents mapped to the TMF Reference Model (version 3.0) at each Study Site. A Study Site consumes an eTMF license if it contains at least one document mapped to any TMF Reference Model artifact except those listed below (which are associated with CTMS and SSU licenses):

CTMS Artifacts:

• Pre Trial Monitoring Report
• Trial Initiation Monitoring Report
• Monitoring Visit Report
• Final Trial Close Out Monitoring Report

SSU Artifacts:

• Feasibility Documentation
• Data Privacy Agreement
• Confidentiality Agreement

To track eTMF license consumption, a new eTMF field is added to the Study Site License object, marked Yes when relevant documents are present for the Study Site. An asynchronous job updates the eTMF field based on Study Sites which have had document changes such as documents created, updated, or deleted. Upon release, the system will perform an initial eTMF license calculation on all Study Sites and update the eTMF field accordingly.

Admins can view license consumption in the Vault About page. This change provides consistency with how other Clinical Operation application license consumption is tracked and provides a more transparent and uniform approach to license management.

CTMS, eTMF

Clinical Transfer CDX EnhancementsAuto-on25R1.3

To facilitate smooth and efficient teamwork among different partners involved in clinical trials, it’s essential to move key information accurately and promptly between different Vaults. Understanding the complexities of these transfers, we’re continuously improving our Clinical Transfer features to make information sharing clearer and more unified across all connected Vaults.

The 25R2 release introduces several key improvements to Clinical Transfers:

1. CTMS Transfer triggers recurring milestone schedule of Recurring Milestone Schedules: Previously, milestones transferred via CTMS Transfer did not trigger the start or end of Recurring Milestone Schedules in the target Vault. This limitation has been addressed. Now, when milestones referenced as Action or Inactivation events are transferred via CTMS Transfer, they will automatically initiate or conclude the corresponding Recurring Milestone Schedules in the target Vault. This enhancement streamlines the execution of oversight plans that involve periodic activities, ensuring timely oversight execution and improved operational efficiency.

2. CTMS Transfer populates new Source Milestone Type and Source Monitoring Event Type Fields: To provide enhanced context and traceability for transferred records, we have introduced two (2) new text fields on the target Milestone and Monitoring Event records: Source Milestone Type and Source Monitoring Event Type. Upon transfer, these fields will be automatically populated with the exact labels of the Milestone Type and Source Monitoring Event Type values from the source Vault. This is particularly valuable when dealing with custom types in the Source Vault, offering clear visibility into the origin and nature of these records.

3. Timeout for Long-Running Agreement Transfers: To optimize system performance and prevent indefinite processing, Agreement Transfers that remain in the Extracting state for more than 24 hours will now automatically timeout and transition to the Finished state. This ensures that transfer processes are effectively managed and that system resources are not unnecessarily held up.

These enhancements collectively contribute to a more efficient, transparent, and reliable clinical data transfer process, ultimately leading to improved accuracy and collaboration across all stakeholders involved in clinical trials.

Subartifacts Support for Clinical TransfersAuto-on25R1.3

Maintaining a well-organized and easily navigable Trial Master File (TMF) is crucial for successful clinical trials and regulatory compliance, ultimately contributing to faster approvals and smoother inspections. The TMF Reference Model version 3 introduced the concept of “subartifacts” offering a way to further define a document within an artifact. This allows for similar documents to be filed within the same “location” but still enables differentiation.

Building upon this industry standard, Veeva Clinical Operations introduced support for Subartifacts in the 24R2 release, including a new Subartifact document field powered by a dedicated Subartifact object. Given that several Clinical Research Organizations (CROs) and Sponsors now leverage this functionality and diligently maintain the Subartifact field in their source Veeva system, it’s essential that this valuable information isn’t lost when documents are transferred to the target Veeva System via TMF Transfer or CTMS Transfer. Ensuring this data integrity directly improves TMF inspection readiness and reduces potential compliance risks.

Our upcoming 25R2 release directly addresses this need with an enhancement to our clinical transfer capabilities. Now, if the Subartifact field is present on a source document, the Source Subartifact field will be automatically populated on the corresponding target document for both TMF and CTMS Transfers. This seamless transfer of subartifact information ensures that the granular document context is preserved in the target system, leading to a more complete, accurate, and inspection-ready TMF. Importantly, to maintain flexibility, documents will still transfer successfully even if the Subartifact field is blank or not present in the source Veeva System.

Study Startup

Study Level Expected Docs in Multi-Country & Site SubmissionAuto-on25R1.2

The Multi-Country and Site Submission feature is enhanced to support Study level Expected Document instantiation for Country level Submission Application Milestones with the Select Specific Country and Site field set to True. This enhancement will be automatically available, but does require template configuration to use, i.e. a Study level Template Expected Document must have a Country level milestone type associated with it.

Electronic CDAAuto-on25R1.3

Study Startup now supports an electronic CDA process within Site Feasibility Surveys. Site Surveys can now include the Response Flag, Electronic Confidentiality Confirmed, to trigger a verification for the recipient to agree to the eCDA. The CDA recipient must be tracked as a Study Person record with a valid email and the Respondent Type field set to Confidentiality Recipient. When the CDA recipient attempts to complete the Site Survey, a new dialog box will ask for the respondent to enter their Full Name and a unique verification code that has been sent to the email associated with the Study Person record. The respondent can verify and complete the survey after a successful code input. The system will copy the Full Name from the verification dialog box onto the completed survey record’s Confidentiality Respondent field.

A CDA document can be generated from a Formatted Output Template upon completion of the survey and filed within the TMF. A notification will be sent to the CDA recipient using the new notification template, eCDA Confirmed, which includes a downloadable PDF version of the CDA. The link to the downloadable CDA expires within 60 days.

Update Survey USN BannerAuto-on25R1.3

Veeva Study Startup has enhanced the existing USN Banner for Feasibility Surveys using Veeva Standard Questions. Several components have been updated including color, icons, accessibility, and inclusion of buttons rather than links. Users can now select a USN through the Enter USN button and update a USN through the Update USN button.

Completed Survey NotificationConfiguration25R1.3

Veeva Study Startup now supports the ability to send a survey respondent a copy of their completed survey and file that completed survey in the TMF. When the Generate Document from Formatted Output action is configured on the Site Survey or Outreach Target Survey object lifecycles, the system will generate a survey response document based on the new Site Survey or Outreach Target Survey Response Formatted Output Templates, will file the response document to the designated Document Classification, and will link the generated document to the new Response Document field on the Site Survey and Outreach Target Survey objects.

A new Person Responsible Email field on the Site Survey and Outreach Target Survey objects automatically tracks the survey respondent email that submitted the Survey. To send a copy of the response document to this survey respondent, the Send Copy to Survey Respondent checkbox should be enabled on the Generate Document from Formatted Output action. New Notification Templates, Download Survey Response, are available for the Site Survey and Outreach Target Survey objects for the purpose of sending the survey respondent a download link to the generated response document. The link to the PDF copy of the completed survey expires within 60 days.

eTMF, Study Startup

Risk-Based Document QCConfiguration25R1.3

This feature introduces the capability to map Document Types to a risk level and develop rules for documents that should be QC’d based on that risk level. A new object, Document Type Risk Mapping, tracks the QC Risk Level for a specified Classification and, optionally, Subartifact. Only one Document Type Risk Mapping can be generated for each Classification and Subartifact. 

QC Risk Rule is a new object that defines the rules associated with each QC Risk Level. These records set the QC Type, Pre or Post-Approval, and the percent that should be sampled for the risk level. These rules can also be defined based on Study, Country, or Organization. For each QC Risk Rule a Risk Rule Metric will be generated by the system. This record automatically tracks the Number of Docs Requiring QC and Number of Matched Documents for the QC Risk Rule.

A document owner can assess a document’s risk through an updated QC workflow configuration that includes a new Risk Assessment System Action step. The Primary and Secondary QC Status document fields must be added to Classifications that use the risk assessment action. Through this action, the system will identify the risk level of the document based on the defined Document Type Risk Mappings. Based on the matched mapping, the system will then assign the QC Risk Rule, increment the Number of Matched Documents on the associated Risk Rule Metric, and determine if the document should be sampled based on a random number generation. If the number generated is less than the Percent Sampled, then the document’s Primary or Secondary QC Status will be updated to QC Required and the system will increment the Number of Documents Requiring QC on the Risk Rule Metric record. The system also will update the Risk Assessment Memo document field with details on the assessment.

CTMS, eTMF, Study Startup

Sync PI EnhancementAuto-on25R1.2

The Sync PI Field with Study Person feature now automatically populates the Primary Contact Information field on Study Person records, respecting the Pre-default on non-required field when only one reference record is available setting when applicable. Previously, this automation failed to populate the Primary Contact Information, even when the setting was enabled and a single Contact Information record existed, leading to inconsistent system behavior and requiring manual user input. This enhancement resolves the inconsistency by ensuring the “pre-default” setting applies uniformly, regardless of whether the Study Person record is created manually or through the Sync PI feature, thereby reducing user effort and ensuring consistent data population.

Disclosures

Critical EA Feedback Enhancements for DisclosuresAuto-on25R1.2

This feature addresses critical feedback from our early adopters during their onboarding and configuration of Disclosures. These following enhancements are essential for successful adoption:

• New Subject Screened Milestone Disclosure Rule: The ClinicalTrials.gov definition of “Study Start Date” can be interpreted in various ways, leading to different customer needs. We added a new Disclosure trigger rule to accommodate those who require an earlier trigger. When activated, this rule generates Disclosures due 21 days after the First Study Subject Screened milestone Actual Date, providing an alternative to the First Subject In milestone.
• New Disclosure Compliance Date (System-Calculated): To address concerns about losing track of the original compliance date, we introduced a new read-only Compliance Date field. This field is automatically calculated by Disclosure Rules upon Disclosure generation and is distinct from the user-editable Due Date field.
• New Reason Created field: To help the disclosure team understand the context for the automatic creation of Disclosures, we added a new Reason Created field. This field displays the Label of the trigger rule that initiated the Disclosure creation.
• Additional fields automatically pre-populated in Disclosure forms: To increase data entry efficiency, Disclosure forms will be automatically pre-populated with the following data points:
  • Study Recruitment Status (from Study)
  • Primary Completion Date (derived from the milestone)
  • Actual Enrollment (derived from Study metrics)
  • EU CT Number
  • NIH Grant Number

Ability to "Check for Updates" and update Disclosure DataAuto-on25R1.2

When a Disclosure is created, data is prepopulated into specific fields and saved. However, the data is not updated after the data is initially prepopulated. This allows users to edit, revise, and control the form data. This feature allows users to compare the data in a Disclosure side-by-side against new information in CTMS. Users can then decide which updates to incorporate into the Disclosure and ensure that the most up-to-date information gets disclosed to the public registry.

Additional EA Feedback Enhancements for DisclosuresAuto-on25R1.2

This feature addresses critical feedback from our early adopters during their onboarding and configuration of Veeva Disclosures. The following enhancements are essential for successful adoption:

• New Copy Entire Protocol user action copies the protocol and all its linked objects that constitute the protocol, including any translations
• Added additional validations for US Registrations to the validation error file

CTG API - Retrieve Study Statuses, NCTID, Comments, and UpdatesAuto-on25R1.2

The new Registration object tracks whether a Study and its results need to be registered on ClinicalTrials.gov or other registries. The Disclosure Scope field controls whether a study will have US Registration and/or Results Disclosures auto-generated.

The ClinicalTrials.gov Protocol Registration System (PRS) API has been enhanced to poll nightly for any Study updates and retrieve data, including the Record Status, the Study’s NCTID, and potential comments. These values are saved to the Registration object for reporting and filtering.

Company Website Support - Custom Fields and XMLAuto-on25R1.2

This feature introduces configuration to include Disclosure or Study object custom fields in a new custom XML submission file for US Disclosures. A new user action is available to generate the file, which customers can use to update their Clinical Trial Search website.

Posting Documents to ClinicalTrials.govConfiguration25R1.3

After a Clinical Trial has been registered on ClinicalTrials.gov and completed, a user must submit the required documents with the Clinical Trial Results. This feature allows users in Veeva Disclosures to include those documents with the Disclosure workflow for review and approval and submit them automatically to ClinicalTrials.gov PRS with the new Post/Update Documents action.

Site Connect

Revoke Site Connect AccessAuto-on25R1.2

This update enhances the Revoke Access from Study Persons with End Date job by adding functionality to also revoke Site Connect access for site users. Previously, this job only revoked access for internal users. However, Site Connect customers manage user access for site staff using Study Persons as well. To ensure consistency and eliminate the manual step of revoking Site Connect access, this release enhances the existing job. 

Now, when the daily job runs, it will uncheck the Site Connect User field for Study Persons whose End Date is on or before the date the job ran. This feature is auto-on for Site Connect customers who have activated the Revoke Access from Study Persons with End Date job.

To prepare for this functionality, we recommend customers activate the Revoke Access from Study Persons with End Date job. It is also important to establish a process for accurately setting the End Date for Study Persons, as the effectiveness of this feature relies on the correct use of this date.

Support VeevaID Email ChangeAuto-on25R1.3

Changes to a site user’s primary email address are common, often due to organizational shifts like mergers or rebranding, or personal reasons such as name changes. Prior to this release, VeevaID did not support updating a user’s primary email once set. As a result, a new VeevaID must be created, causing the user to lose all existing study access in Site Connect and requiring sponsors to manually reassign access to each relevant study.

With this release, VeevaID now supports updating a user’s primary email. This Site Connect feature enables Site Connect to seamlessly support these VeevaID email changes. Now, when a site user updates their primary email address in VeevaID, Site Connect automatically reflects this change by updating the corresponding records within Veeva Clinical Operations Platform. This enhancement ensures that site users retain uninterrupted access to their assigned studies, eliminating the need for sponsors to manually reconfigure user access. 

By automating this process, we reduce administrative burden and minimize potential access disruptions, leading to a smoother experience for both site users and sponsors.

Safety Distribution ResponsibilityAuto-on25R1.3

This feature allows for more flexibility in the selection of Safety Distribution Recipients in Site Connect. After the release, a Study Person is determined to be a primary or secondary safety recipient if they have the Assess Safety Notifications (Primary) or Assess Safety Notifications (Secondary) Study Person Responsibility respectively. 

These two Study Person Responsibilities will be automatically created for Study Persons who have a Study Team Role with Safety Distribution Recipient set to Primary or Secondary. This ensures there is not an immediate change in behavior after the release. 

On release night, all Study Persons with a Study Team Role Safety Recipient field set to Primary or Secondary will have the respective Study Person Responsibility created for them if the study Connected Study Type field includes Safety Distribution. This ensures all existing Study Persons will continue to have the appropriate Safety Recipient.  

To prepare for this change, it is recommended that admins configure permissions for the Responsibility and Study Person Responsibility objects and set up the Study Person Responsibility section on the Study Person page layout. This configuration can be done before the 25R2 release as these objects are already available. This will enable users to effectively manage Study Person Responsibilities for Safety Recipients.

Document Exchange ResponsibilityAuto-on25R1.3

This feature allows for more flexibility in the selection of who should receive Document Exchange notifications. After the release, a Study Person will only receive Document Exchange notifications if they have the Maintain Essential Documents type Study Person Responsibility. 

This Study Person Responsibility will be automatically created for Study Person who have a Study Team Role with Document Exchange Recipient checked. This new field on Study Team Role will be automatically checked for our standard Principal Investigator, Sub-Investigator, Clinical Research Coordinator, and Regulatory Coordinator Study Team Roles. This ensures there is not an immediate change in behavior after the release. 

On release night, all Study Persons that are Site Connect Users will have this Study Person Responsibility created for them if the study Connected Study Type field includes Document Exchange. This ensures all existing Study Person will continue to receive Document Exchange notifications.

Auto-Doc EDL Exchange EnhancementsAuto-on25R1.3

This feature enhances the Automated Document Exchange from Expected Documents, improving efficiency through a dynamic process. The system now dynamically manages document requests by comparing the # Expected count to the All Document Count:

• Automatic Requests: Provide Original distribution tasks are created when the # Expected field value increases beyond the All Document Count field value for Expected Documents flagged as Auto-request from site that are required.

• Automatic Cancellation: Open distribution tasks are cancelled when the # Expected field value decreases or when new documents are matched to an Expected Document via manual upload, causing the All Document Count field value to increase. This cancellation applies only to distribution tasks created after this release.

As part of this enhancement, an Expected Document field is added to all distribution tasks. This new field enables the system to automatically apply references (person, organization, or subartifact) from the corresponding expected document to documents returned from the site, provided those references exist.

Subartifact Support for Site PackagesConfiguration25R1.3

This feature introduces Subartifact support within document exchange. A new Subartifact field is available within Site Package Document records allowing Site Connect customers to leverage the new document filing structure introduced in a prior release. 

When the Enable Subartifacts flag is active, the Subartifact field becomes mandatory for Site Package Documents, and any ad hoc document requests initiated through packages will require a Clinical Operations user to specify a Subartifact. To ensure clarity for site users, the system will automatically include the selected Subartifact name in the comments of ad hoc requests. 

Additionally, the Subartifact field will be visible in the document exchange grid, providing insight into each document’s specific Subartifact. Subartifact information will also be stored on Distribution Tasks, ensuring a consistent and seamless document exchange experience.

Site users do not set the Subartifact value on the document. For document requests, the system will set the Subartifact on the document provided by the Site based on the value of the associated Distribution Task. If documents are uploaded ad hoc by the site, the Subartifact will be set to one that matches the classification name.

For customers who have not enabled Subartifacts, the document exchange grids and ad hoc document requests through site packages will remain unchanged, with the Subartifact field not being displayed.

Site Connect HardeningAuto-on25R1.3

Several enhancements are included in this release to better support Site Connect: 

• Documents returned from the site as a response to a Provide Original task will always be filed to the requested Classification and Sub-Artifact
• Site Connect maintains the initial completed by and completed date on Distribution Tasks
• Site Connect continues to allow access to documents moved from In Progress to Approved if the content did not change
• Updates to job orders to now avoid overlap in jobs and ensure efficient runtimes
• Improvements now allow users to enable Site Connect Users in bulk in cases where thousands of Study Persons need to have Site Connect User enabled
• Distribution Tasks fail when the associated Site Connect User is inactive
• Ensure Gap Packs with a large number of safety distributions are supported via email

25R2 Site Connect Vault Clinical Document UpdatesAuto-on25R1.3

Using Site Connect, Sponsors and Sites can seamlessly exchange documents. This feature has expanded the document types that can be exchanged.

The following Document Types are now able to be received from sites:

• Site Training Material
• IP Shipment Documentation

The following Document Types are now able to be sent to sites:

• Regulatory Notification of Trial
• IP Shipment Documentation

New Standard Study Team Roles & Application RolesAuto-on25R1.3

This feature introduces new standard Study Team Roles and Application Roles for the following site-facing roles: 

• Budgets & Contracts (budgets_contracts__v)
• Data Coordinator (data_coordinator__v)
• Other Non-Investigator (other__v)
• Pharmacist (pharmacist__v) 
• Regulatory Coordinator (regulatory_coordinator__v)
• Research Nurse (research_nurse__v)

Vaults with Site Connect enabled will have these records active by default, whereas Vaults without Site Connect enabled will have the records inactive by default.

Roles & Responsibility - Data Model OnlyAuto-on25R1.3

This feature introduces the data model for the Roles & Responsibility Site Connect feature coming in 25R3. The data model is automatically available in all Clinical Operations Vaults with Site Connect enabled, but is not leveraged in any feature. The data model updates include a new Site Staff Change Request object, along with an associated lifecycle and object action.

The 25R2 Clinical operations Data Model documentation will provide additional details on these changes.

End Site User Access on End DateAuto-on25R1.3

This feature ensures that Site Connect access is automatically removed when a site staff’s participation in a study has ended. The recently released Revoke access from Study Person on End Date job has been updated to automatically uncheck the Site Connect User box for site Study Persons once their End Date has passed.  

To prepare for this functionality, it is recommended that customers activate the Revoke Access from Study Persons with End Date job. It is also important to establish a process for accurately setting the End Date for Study Persons, as the effectiveness of this feature relies on the correct use of this date.

Respect Start/End Dates on ResponsibilitiesAuto-on25R1.3

This feature ensures that access and notifications for various Site Connect capabilities are strictly controlled by the Start and End Dates defined on Study Person Responsibilities. This means that users will only be able to access features and receive notifications if the current date falls within the Start and End Dates of their assigned Study Person Responsibility.  

The capabilities affected by this enhancement include Safety Distribution (for both primary and secondary safety distribution access and notifications), Document Exchange (for notifications only), Unblinded Documents (for unblinded content access and notifications), and Payment Information (for access to payment information).  

To prepare for this change, it is recommended that admins configure permissions for the Responsibility and Study Person Responsibility objects and set up the Study Person Responsibility section on the Study Person page layout. This configuration can be done before the 25R2 release as these objects are already available. This will enable users to effectively manage Study Person Responsibility Start and End Dates.

Site Connect, Study Startup

USN Sign Up EnhancementsAuto-on25R1.2

This release adds new required fields to the USN sign-up process. The First Name, Last Name, and Email fields are now required for all USN sign-ups. The Department field is required for Hospitals and Academic Medical Centers. Collecting this information allows the Veeva Site Support team to make more informed decisions, efficiently contact sites with queries, and improve alignment with the SiteVault sign-up process. 

Additionally, it enables sites to receive automated email notifications regarding their USN application status. Applicants will receive email notifications when their USN application is successfully created, when it is approved, and when it is rejected. This feature is auto-on.

Study Training

Facilitated Training: Training Assignment Completion for Superseded DocumentsConfiguration25R1.2

This Facilitated Training enhancement allows Training Admins to complete cancelled Training Assignments for superseded documents. This is useful in larger organizations where Learners complete training outside of Vault, then Training Admins log the history in Vault on their behalf. This process takes time, during which the associated documents could become superseded and thus cancel the related Training Assignments. 

With a new “Cancelled Training Assignment” page layout section on the Facilitated Training Request object types for Curricula and Training Requirements, Training Admins can review and select cancelled Training Assignment records and their associated documents within the related Training Content Set. When the Facilitated Training Request record moves to a lifecycle state where the Update Training Assignments entry action is configured, the Facilitated Training async job moves these cancelled assignments to the Completed state.

Multi-Study Document EnhancementAuto-on25R1.2

This feature enhances how Study Training auto-creates Training Requirements for multi-study documents (a document used in more than one Study). Currently, when Vault transfers a multi-study document from eTMF to Study Training via the connection, Study Training creates one Training Requirement to be shared across multiple Study Training matrices. This results in imperfect security. With this enhancement, when a document is re-used in multiple studies, Study Training creates a unique Training Requirement for each Study.

Training Matrix DraftAuto-on25R1.3

This feature allows a Training Admin to save a draft of their changes to a Training Matrix and return to their work later. Previously, when a user made edits to a Training Matrix, the changes can either be discarded or made immediately live. 

Users can now:

• Edit the Training Matrix and save their work without necessarily publishing
• Leave and return later as needed
• Toggle between the currently live Training Matrix and draft Training Matrix Update
• Discard the draft Training Matrix Update if no longer needed
• Publish the Training Matrix Update, making it the new live matrix

Additionally, while editing a draft Training Matrix, users can manually add Study Country sections to the Training Matrix without relying on matrix automation. A new button directly within the Study Training Matrix Builder provides users with the flexibility to add a new Study Country section for country-level Training Requirements. Previously, new Study Country sections appeared on a Training Matrix only when an eTMF document was approved and indicated as Connected with Veeva Study Training.

This feature automatically updates the following Permission Sets to include Read and Edit permissions for the Training Matrix Update object: Vault Owner Actions, Vault Training: Business - Administrator Actions, Vault Training: Study Training Admin Actions, Vault Training: System Administrator Actions.

This feature is auto-on for studies using the Automated Training Matrix (V2 Matrix). It does not impact studies using the manual matrix (V1).

Support for Specialized ResponsibilitiesAuto-on25R1.3

In 25R2, Veeva Clinical Operations is introducing the ability to add Specialized Responsibilities to the existing standard list of Responsibilities. This enhancement benefits responsibility-based training in Study Training by allowing users to create more granular Responsibilities, thus preventing overtraining of site staff.

Training Admins can expect specialized Responsibilities to behave the same as standard ones: The connection transfers them from Clinical Operations and are treated as Learner Roles in Study Training. 

This feature introduces Active Query Object Rule updates to the applicable Integration Points, as well as new fields on Clinical Responsibilities and Study Person-Responsibilities to help determine whether those records should be sent to Study Training.

Study Training Matrix Builder EnhancementsAuto-on25R1.3

Study Filter

When a user selects a Training Requirement to add to the Study Training Matrix Builder, Vault pre-populates a new Study filter with the Study record the user is currently viewing.

Global Section Re-labeled for Studies

The “Global” section label in the Study Training Matrix is now re-labeled to “Study”. Previously, the “Global” label could be misleading, as it conveys items that are non-Study-specific.

VeevaID Single Sign-On Support for Study TrainingConfiguration25R1.3

In this change, Federated IDs can be added to Persons prior to a Study Person record being transferred to Study Training.

The purpose of this feature is to automatically assign a Federated ID to a Person record when one is not detected. For example, when a Study Person is created in Study Training via the Study Training-Clinical Operations Connection and the related Clinical Person has a Federated ID value, Vault transfers the Federated ID value from the Clinical Person record to the Veeva ID user that is created in Study Training. If a Federated ID already exists, it will be maintained and not overridden. 

For existing users without a Federated ID, customers must manually update the user records. 

For more details and feature enablement, see Veeva ID for Study Training.

Auto-on Training & Study Training EnhancementsConfiguration25R1.3

Instructor-Led Training Search Enhancements

Search functionality is improved for multiple Instructor-Led Training sections, including clearing searches when switching between tabs. Additionally, the total count of Learners displayed on the Roster and Waitlist remains the same, regardless of search values.

Quality Relationships Panel: Support for External and Evaluation Training Requirement Types

On the Quality Relationships panel’s Training Requirements section, there is an Add button that allows the user to select Training Requirements from a dialog. Selected requirements then have the document added to their content set. In the past, this was only applicable to Document and Classroom types, since only those types could contain documents.

Learner Homepage & Task Page: Assignments with Archive Documents

Previously, when viewing a Training Assignment with an archived document, the Learners were presented with an error on the Learner Homepage and on the assignment’s task page. After this enhancement, Learners view an assignment with an Archived document in these locations, Vault informs them that the document is archived.

Learner Home Page: Desktop View Accessible from Mobile

The My Learning Mobile view now contains links for the Open, History, and Explore tabs, which open in a browser tab when selected.

Learner Home Page: Open Training Assignments Count Matches the Filtered Training Assignment Count

In the My Learning > Open tab, the count of Open Training Assignments on the left side bar now updates when a user applies filters. Previously, this number did not automatically update when using a filter.

Automatic Completion Credit for Document ParticipantsAuto-on25R1.3

In certain scenarios, document participants (for example, Owners or Approvers) do not need to complete training for the documents they worked on. This feature allows Training Admins to automatically grant training credit to these select document participants.

Vault Admins can configure the Provide Participant Training Completion Credit system action within a document or a document change control (DCC) workflow. They can select one or more participant groups in that workflow to grant the automated credits. When Vault issues training for that document’s Training Requirement, it automatically completes related assignments for these participants.

An Admin can also configure a section on the Training Requirement Impact Assessment (TRIA) object page layout (“Training Completion Credit Users”) which displays all the Learners for whom Vault will grant automatic credit when issuing related assignments. With this information, Training Admins can modify the list of users. This feature does not support Vault Document Training Requirements with multiple documents. When there are multiple items in the content set associated with a requirement’s latest TRIA, Vault displays a warning message: “This is a multi-item training requirement. Automated participant credit is not currently supported”.

This new feature also allows Training Admins to determine whether automated completion credit is allowed at a Training Requirement level. They can use a new Allow Document Participant Credit? field on the requirement to specify whether that requirement should be processed with automated credit. This new field also exists on the TRIA object, where the Training Admin can modify the field during their assessment. When either field is modified, Vault synchronizes them.

LearnGxP ContentDirect: Learner Homepage Course ImagesSupport25R1.3

The goal of this new feature is to allow displaying images for LearnGxP Training Requirements on Learner Homepage cards. Previously, Training Admins were required to manually upload the image. Displaying images helps Learners easily identify the course and saves Admin maintenance time. 

When enabled in LearnGxP ContentDirect, Vault automatically pulls images along with SCORM content. Consequently, when Vault auto-creates Training Requirements, the related job automatically associates relevant images with the course or display on the Learner Homepage.

Equivalency Substitute Training RulesConfiguration25R1.3

This feature introduces Equivalent Training Rules, where a primary Training Requirement (or one that is part of the Learner’s current Training Matrix) can be indicated as equivalent to another primary requirement: When a Learner completes training for an equivalent, they receive credit for both, as shown in Use Case 1 below. Equivalency can also be bi-directional, where the configured rules allow the Learner to complete either primary requirement and receive credit for both, per Use Case 2.

This feature also improves upon existing Substitute Training Rule functionality, enabling a new use case where a primary Training Requirement can be indicated as a substitute for another primary requirement. Previously, a primary Training Requirement could only be substituted by a requirement outside of the Learner’s matrix. In contrast to equivalent rules, Substitute Training Rules cannot be made bi-directional: In the case of two requirements (primary or non-primary), only one can be substituted for the other. This new capability can be seen in Use Case 3.

With a new Training Rule Substitution Type picklist, Training Admins select the Full option to completely “swap” one primary requirement for another when creating a Substitute Training Rule. Other picklist values support this feature’s accompanying Delta Training and Refresher Training features.

Use Case 1: Simple Equivalent Rule

A Learner’s Training Matrix includes two Training Requirements on the topic of gowning: One for an instructor-led training (ILT) and another for the Learner to independently read and affirm understanding of a training document (R&U). Though the “Gowning ILT” is more in-depth than the R&U training, Learners are currently required to complete assignments for both, as they are based on primary Training Requirements (any requirement in their Training Matrix).

With this feature, a Training Admin can configure a training rule on the “Gowning R&U” requirement such that “Gowning ILT” is considered to be its equivalent. This means the Learner can attend only the ILT session on gowning (in lieu of reading the training document) and automatically satisfy the “Gowning R&U” assignment while remaining in compliance with their Training Matrix.

Use Case 2: Bi-Directional Equivalent Rules

The “Gowning R&U” requirement and related Training Materials are up for biennial review. During the review, a “Gowning ILT” instructor notifies the Training Admin that the “Gowning R&U” requirement’s updated materials now match the depth of content covered in the ILT session, and that these requirements are now equivalent to each other.

To accommodate this within the Training Matrix, the Training Admin configures a second training rule such that the “Gowning R&U” is considered to be the equivalent of “Gowning ILT”. This new rule can be configured on either requirement, as Vault ensures any configured training rules are visible within all impacted requirements.

Together, the rules described above make the equivalency relationship bi-directional: Learners can now complete either the “Gowning R&U” or the “Gowning ILT” assignment and satisfy the one they did not complete.

Use Case 3: Bi-Directional Equivalent Rules with a Full Substitute

As part of the “Gowning R&U” requirement’s biennial review described above, the requirement’s new English-language Training Materials were translated into Spanish, and those materials are now part of a new “Gowning R&U - Spanish” requirement. This new requirement supports a use case of the existing Substitutes feature, where Vault can dynamically assign training based on a Learner’s locale.

The Equivalency Substitute Training Rules feature allows a Training Admin to apply basic substitute behavior to more complex situations such as bi-directional equivalency: With a third training rule for this group of requirements, Learners opting to complete the “Gowning R&U” are automatically assigned “Gowning R&U Spanish” when their Person record’s Language is “Spanish”. This English-Spanish “swap” is considered to be a full substitution; see Delta Training and Refresher Training for other substitution types.

Delta TrainingConfiguration25R1.3

Delta Training enables organizations to develop shorter training materials focused on delta training content (changes between document versions) then assign them to Learners who have previously completed an assignment for that requirement. This reduces training time and improves knowledge retention, as these Learners are only required to understand the latest round of updates.

Prior to Delta Training, any re-training as a result of recurrence required Learners to re-train on all training materials, even for minor process updates. Delta Training allows a Training Admin to, for example, send Learners a brief PowerPoint presentation covering only the latest updates to the Gowning Standard Operating Procedure (SOP). See the use case below for an example of how this appears within a Training Matrix.

Use Case: Single Equivalent Rule with a Delta Substitute

Learners assigned the “Gowning R&U” Training Requirement via their Training Matrix (a primary Training Requirement) are able to complete the “Gowning R&U Delta” requirement in lieu of the full set of materials contained within the primary requirement for which they previously completed training, for example as part of their new-hire training. 

This example of a Delta Substitute Rule is similar to another use case shown for this release’s Equivalency Substitute Training Rules feature: For Use Case 3, Vault provides full English training materials for Spanish ones in certain cases (a Full Substitute Rule). Here, a Delta Substitute Rule enables Vault to instead provide the delta materials when assigning training for the “Gowning R&U” requirement. See the Equivalency Substitute Training Rules feature for more information on how the “Gowning ILT” requirement can satisfy “Gowning R&U”.

Refresher TrainingConfiguration25R1.3

Refresher Training enables organizations to develop shorter training materials focused on refreshing or “renewing” a Learner’s knowledge on the most important aspects of a requirement in their Training Matrix (a primary Training Requirement). Vault issues these specialized materials using a Training Admin-configured Refresher Substitute Rule: When a primary requirement recurs, Vault substitutes the refresher content for the primary requirement’s content for any Learner who has previously trained on that requirement.

For example, a Vault Document Training Requirement for a particular SOP recurs every two years, relative to the last time a Learner completed an assignment for that requirement. When this requirement is configured with a Refresher Substitute Rule, Vault assigns the refresher requirement’s content to Learners, in lieu of the primary requirement’s Training Materials. This reduces training time and improves knowledge retention, as Learners are only required to focus on the refresher-oriented content.

OpenData Clinical

Investigator Affiliation to Multiple SitesAuto-on25R1.3

This feature creates multiple Contact Information records in Vault for OpenData Clinical Investigators who are affiliated with multiple research sites. While one affiliation will be considered Primary within the OpenData Clinical dataset, an action on the Person record will allow customers to select which site affiliation they consider as Primary for a given Investigator. This allows customers to continue to benefit from OpenData Clinical’s curated data while adjusting it to align with their business needs.

Parent Site RecordsAuto-on25R1.3

This feature delivers parent Organization records as part of the OpenData Clinical (ODC) data set, and updates delivered Site records to reference their parent. With this, multiple departments within a large hospital or center, or clinics within a research network will be aligned under a single parent record. This provides valuable organizational context, and supports cross-site reporting, in a clear and simple hierarchy.

As part of this feature, ODC will leverage the new Available as Study Site field. Parent entities that are not proper research sites will have Available as Study Site set to FALSE, while child Sites within them will have a value of TRUE. This will ensure proper usage of records as Study Sites.

eCOA

eCOA Vault

End-of-Study Database Lock for Sites and Studies Available for Use25R1.3

This feature introduces the ability for Sponsor/CRO Staff with the Study Builder or new Lead Data Manager roles to lock and unlock study sites and the overall study database from eCOA Vault to ensure data integrity at the end of a study.

Key capabilities include:

• Site Lock: Restricts site user actions and deactivates participants. Any data received after the lock is initiated is held separately and processed by request..
• Site Unlock: Allows site users with specific permissions to update data. The site must be unlocked before any sequestered data is accepted.
• Study Lock: Restricts all actions in eCOA Vault and Studio and prevents sites from being unlocked.
• Study Unlock: Enables users to make necessary updates to the study and allows sites to be unlocked.

Learn more about locking databases and unlocking databases.

Generate End-of-Study Media Available for Use25R1.3

This feature enables Sponsor/CRO Staff with the necessary permissions to generate and download the following comprehensive study and site data for a locked study:

• Participant data (includes clinical data audit trail)
• System audit trails
• User access information

Data is packaged per site. All restricted data is included and access to the documents in eCOA Vault is aligned with user ability to access restricted data. This media can be used for site data retention, regulatory compliance, and eTMF filing.

Learn more about generating end-of-study media.

Studio

Display Vertical Visual Analog Scale as Simple Line Available for Use25R1.3

This feature allows Sponsor/CRO Staff to configure the vertical visual analog scale to be displayed as a simple line using a new displayType parameter. The simple line can be used as needed to meet copyright and stakeholder expectations for survey display. The bar visual is displayed by default if the parameter is not configured.

Learn more about configuring a Visual Analog Scale (VAS).

Upload Multiple Translation Files at OnceAuto-On25R1.2

Sponsor/CRO staff can save time by uploading multiple .JSON translation files at a time. If any files are not uploaded successfully, an error log is available to describe the specific files and what problem is preventing the upload.

Study Home and Reporting

Criteria Check Results in Study Home Auto-On25R1.3

Sponsor/CRO staff can now access results from site criteria check events in the participant-level Events section in Study Home. Selecting the criteria check link opens a drawer that displays all associated results for that participant, presented in chronological order with the newest logs at the top. This enhancement enables sponsors to view event results for individual participants without needing to generate and search through reports.

Learn more about viewing criteria check results with the participant-level data in Study Home.

New Standard Reports Available for Use25R1.3

This feature introduces two new standard reports:

• Participant Events
• Participant Groups

These reports contain information for either participant events or participant groups all in a single view, and can be run from Study Home or as an Export Job in Studio.

Learn more about the Participant Events report specifications and Participant Groups report specifications.

Custom Exports Available for Use25R1.3

This feature allows sponsor/CRO staff to create custom data exports by selecting columns, renaming column headings, and configuring filtering and sorting preferences. Sponsors can use these custom exports in Export Jobs and can choose to also make them available in Study Home.

Learn more about working with custom exports.

Enhanced Export Options (Domains, Configurable Export Labels, Local Time Zones) Available for Use25R1.3

This feature improves standard reports by allowing sponsors to define survey domains (QS, FT, RS) and customize export values for question names, question headings, answer names, and answer labels for better alignment with Study Data Tabulation Model (SDTM) standards. Users can also export system timestamps in the local time zone where the data was collected.

Learn more about customizing export values.

25R2 Feature Audit EventsAuto-On25R1.3

This feature enables the system to add relevant user actions from 25R2 features as audit events on the MyVeeva audit trail.

Configurable Export Job SchedulesAvailable for Use25R1.2

This feature enables sponsor/CRO staff to customize the schedule of each FTP and CDB export job and when they should start. Sponsor/CRO staff can also choose a recurrence interval for all jobs, such as every hour, every few days, or on a monthly basis.

Learn more about configurable export job scheduling.

CDB Connection ImprovementsAuto-On25R1.2

This feature enables the following Clinical Database (CDB) updates:

• Improved File Security: The system for delivering CDB files has been updated to a more secure file staging server. This change improves the reliability and security of data transfers.
• Compliance Report Availability: Compliance reports are now included with CDB connections. They are included in the same package as survey data.
• Descriptive Naming: CDB .ZIP files now have a more descriptive naming format: _eCOA_.zip, for example, GLR305-E001_eCOA_20241218030251234.zip.

Veeva eCOA (Sites)

Reduced PII Collection for Participant and Caregiver Registration Auto-On25R1.3

This feature updates the participant and caregiver registration process in eCOA to only require the year of birth, removing the need to collect first name, last name, and full date of birth.

Support Chat for Sites Auto-On25R1.3

This feature adds a chat button to all eCOA pages, allowing site staff to directly access Veeva support chat for assistance without leaving their current task.

Downtime Notification Immediately Before eCOA System UpgradeAuto-On25R1.3

This feature updates eCOA to display a notification right before system downtime begins to inform site staff of the planned downtime and prompt them to save any in-progress work to avoid data loss.

New Survey Status: Intentionally Left BlankAuto-On25R1.2

Site staff can now mark a participant survey that has not yet passed the due date as Intentionally Left Blank. This enables sites to clean up participant task lists and avoid capturing duplicate data. Surveys with this status can be transcribed.

The audit log and reports will include this status.

Learn more about managing survey availability and status.

MyVeeva for Patients

General

Password-Authentication Added for In-Person Access Available for Use25R1.3

This feature allows Sponsor/CRO Staff to require participants to use a password to access in-person surveys for added security. When the Password-Authenticated setting is selected for the Enable In Person Flow, participants will either log in with their existing MyVeeva log-in information or create log-in information when site staff start an in-person survey. The setting is controlled at the study level and can be turned off at the country or site level in eCOA Vault.

Learn more about managing in-person survey access.

Commercial

PromoMats

eCTD: Empty Required Fields Warning MessageAuto-on25R1.2

With this release, users receive a warning message while generating an eCTD compliance package if the package contains documents with document fields that are empty but required. 

OCR for Images in Powerpoint & Word FilesAuto-on25R1.2

​​​​Microsoft Office Word and PowerPoint source documents that contain images now undergo Optical Character Recognition (OCR). Text contained within images in these documents is extracted and combined with any existing text on the document for the final OCR output. This brings Word and Powerpoint documents inline with the OCR performed in PDF documents.

Learn more about OCR.

Text Assets: Product Data Model for Auto-LinkingAuto-on25R1.2

For customers using Product Family, Product Form, and Product Variant in PromoMats, the fields are now provisioned for Text Assets, enabling them to be used with Auto-Linking.  If a document is specific to the extended data model, only Text Assets with the same values are Auto-Linked. The fields are also available as filters when manually linking Text Assets.

Claims: Auto-Linking DeduplicationAuto-on25R1.3

With this enhancement, Veeva PromoMats only provides new Claim links each time Auto-Linking runs, and does not recreate any previously rejected links unless the user action to run with rejected links is configured. This feature helps streamline the Claims linking experience by reducing duplicative manual effort by users.

Product Family Generic Name Field Length IncreaseAuto-on25R1.3

This feature increases the Generic Name (generic_name__v) field on the Product Family (product_family__v) object to 500 characters. Previously, the maximum length for this field was 100 characters.

Commercial Content Kernel UpdatesAuto-on25R1.3

We have introduced a new document type to the Commercial Content Kernel for Brand Guidelines. Also, the description for the References > Labeling document subtype is updated to include Medication Guides.

Notification Templates: Phrase Vault Support Updated to Veeva SupportAuto-on25R1.3

This enhancement replaces the phrase “Vault Support” with “Veeva Support” in the email body and notification text of select Notification Templates’ email body and notification text. The following templates are only updated if the text of the notification has not been modified by customers. This means that if a customer modified a template, we will not override their modifications.

This feature updates the following templates: 

• auto_image_rendition_fail__v
• auto_image_rendition_failure__v
• automated_image_rendition_failure__v
• formgenerationfailure__v
• generateclmpreviewerror__v
• make_a_local_copy_job_failure__v
• mergefieldsnotifications__v
• pdfacreationfailure__v
• pdfcreationfailure__v
• sandbox_job_error__v
• sandbox_snapshot_upgrade_failure__sys
• scheduledjobcancellationnotice__v
• scheduledjoberror__v
• veevaid_vault_user_creation_exception__v

Portal: Dynamic WidgetsConfiguration25R1.3

Vault now supports Dynamic Widgets, allowing users to automatically populate Portal widgets with documents using custom views from the Vault Library or Portal Library. Unlike static widgets, which require manual curation, dynamic widgets update automatically as documents enter the Vault that match the defined filter criteria.

This feature benefits Portal Admins, Business Admins, and end users by reducing manual maintenance effort and ensuring content in the Portal stays current. It enables teams to publish automatically refreshed views of document sets without needing to update the widget manually.

Portal Admins can create up to 10 Dynamic Widgets per Portal.

Disable Suggest Links Until Document Processing is CompleteAuto-on25R1.3

When manually performing Suggest Links on a document, the Suggest Links button is now disabled until Optical Character Recognition (OCR) is complete.

If Suggest Links is performed before OCR is complete, some document text may not be recognized, leading to incomplete results. This enhancement helps reduce that possibility. Users do not need to refresh the page; the Suggest Links button is automatically enabled once OCR is complete.

Learn more about OCR for Scanned and Mobile Files.

Medical

MedComms

Scientific Statements: Statement AssetsConfiguration25R1.2

With this release, we have introduced the option to add assets to a Scientific Statement, such as images, charts, tables, and other document-based content. Often, Scientific Statements can be encapsulated within a visual or graphical component, such as a chart that represents the statement graphically. Similarly, visual components may support or help explain the meaning of the Scientific Statement.

Communication Objectives for DocumentsConfiguration25R1.2

Users can now gain insight into strategic outcomes by linking Communication Objectives to content. In addition, when using Scientific Statement Auto-Linking, Vault automatically associates Communication Objectives linked to Scientific Statements with the documents.

Learn more about Communication Objectives.

Scientific Statements: Auto-Linking DeduplicationAuto-on25R1.3

With this enhancement, Vault only provides new Scientific Statement links each time Auto-Linking runs, and does not recreate previously rejected links unless the user action to run with rejected links is configured. This feature helps streamline the Statement linking experience by reducing duplicative manual effort by users.

Scientific Statements: HarvestingConfiguration25R1.3

Scientific Statements can now be harvested from Document Link annotations. Using either an entry action or user action, Veeva MedComms attempts to extract the highlighted text and supporting substantiating references to automatically populate Scientific Statement object records. This feature can be used for both area and text annotations, and is designed to identify and avoid generating duplicate Scientific Statement records.

Learn more about harvesting Scientific Statements.

Scientific Statements: Lifecycle Entry Criteria for SubstantiationAdmin Checkbox25R1.3

This feature enables users to move Scientific Statements to their steady states, and  link them to content, without requiring linked substantiating references. Prior to this release, Veeva MedComms required linked references for the Scientific Statements to enter their steady states, which limited the use of Scientific Statements where no substantiation is needed.   

Portal: Dynamic WidgetsConfiguration25R1.3

Vault now supports Dynamic Widgets, allowing users to automatically populate Portal widgets with documents using custom views from the Vault Library or Portal Library. Unlike static widgets, which require manual curation, dynamic widgets update automatically as documents enter the Vault that match the defined filter criteria.

This feature benefits Portal Admins, Business Admins, and end users by reducing manual maintenance effort and ensuring content in the Portal stays current. It enables teams to publish automatically refreshed views of document sets without needing to update the widget manually.

Portal Admins can create up to 10 Dynamic Widgets per Portal.

MedInquiry

Standardization of Responses & InteractionsAuto-on25R1.2

In an effort to further standardize MedInquiry, we are provisioning new Case Response object types (Chat and Internal Email), new Case Response fields (Response Content and Interaction Type), a new field on Event Product (Case), and a Cancelled lifecycle state on Case, Case Request, Case Response, and Event objects.

Automatically Detect Product During Email IntakeAdmin Checkbox25R1.3

Today, MedInquiry supports automatic Product detection on ingested emails. This feature extends Product detection to include Local Product detection to account for the new product data model.

All Medical Applications

Medical Settings & Field Re-labelingAdmin Checkbox25R1.3

We have relabeled the following settings and fields:

• Admin > Settings > Application Settings
  • Current label: Medical Inquiry
  • New label: MedInquiry Settings
• Admin > Configuration > Objects > language_v
  • Current field label: Vault Medical UUID
  • New field label: Medical UUID
• Admin > Configuration > Objects > controlled_vocabulary_v
  • Current field label: Vault Medical UUID
  • New field label: Medical UUID

Notification Templates: Phrase Vault Support Updated to Veeva SupportAuto-on25R1.3

This enhancement replaces the phrase “Vault Support” with “Veeva Support” in the email body and notification text of select Notification Templates’ email body and notification text. The following templates are only updated if the text of the notification has not been modified by customers. This means that if a customer modified a template, we will not override their modifications.

This feature updates the following templates: 

• auto_image_rendition_fail__v
• auto_image_rendition_failure__v
• automated_image_rendition_failure__v
• formgenerationfailure__v
• generateclmpreviewerror__v
• make_a_local_copy_job_failure__v
• mergefieldsnotifications__v
• pdfacreationfailure__v
• pdfcreationfailure__v
• sandbox_job_error__v
• sandbox_snapshot_upgrade_failure__sys
• scheduledjobcancellationnotice__v
• scheduledjoberror__v
• veevaid_vault_user_creation_exception__v

Quality

Batch Release

Disposition DependencyConfiguration25R1.2

Batch materials with multiple Batch Dispositions Plans can have dependencies that block a disposition decision until other disposition decisions are made. For example, your organization may want to block all market-ship decisions until the batch’s GMP Batch Disposition has been accepted.

25R1.2 EnhancementsConfiguration25R1.2

Manufacturing Site-Specific Plans

You can now associate Batch Disposition Plans with a manufacturing site. By associating plans with manufacturing sites, you designate those plans to be used with dispositioned batches manufactured at those sites. This can be useful if you have manufacturing site-specific requirements to meet.

Subtypes and Classification Support for Document Check

When creating a Batch Disposition Check for documents, in addition to specifying a document type, you can also specify a document subtype and classification, which can allow for more granularity in which documents you want to monitor. 

Batch Roll-up Fields

To improve reporting on Batch Dispositions and Batch Disposition Checks, three (3) new boolean fields have been introduced:

• Item State Check: This field is set to True when all items on a Batch Disposition Check are Closed.
• Check Decision Check: This field is set to True when all check decisions on a Batch Disposition are Compliant.
• Check State Check: This field is set to True when all Batch Decision Checks on a Batch Disposition are Complete.

Change State ConfigurationConfiguration25R1.3

This feature configures the Change Control lifecycle states monitored by Batch Dispositions so that changes in any state can be monitored, not just those tied to the Approved state type. 

Today, we monitor changes in the lifecycle state that are related to the Approved (approved__v) state type. This feature will make this configurable by Check Requirement so that changes in any state can be monitored. 

The Change Control State field on the Batch Disposition Check Requirement will display a list of Change Control lifecycle states. Users can select multiple states at a time. Vault evaluates this field only when the Check Requirements object type is Quality Event Type and the batch Quality Event is Change Control and it has been configured to display.

Disposition Archival DesignSupport25R1.3

This feature archives batch release records to ensure that performance doesn’t degrade in high volume environments.

Batch Dispositions in a terminal state, such as Closed or Cancelled, for over 24 months are archived. Vault will attach a PDF document to the batch with all the Batch Disposition, Batch Disposition Check, and Batch Disposition Item data, and the Batch Disposition, Batch Disposition Check, Batch Disposition Item, and Batch Disposition - Country records are deleted.

Monitor Documents That are Not Batch SpecificSupport25R1.3

This feature includes documents in a Batch Disposition Check that are not batch-specific, like BSE/TSE documents, so that they can be reviewed before you make a disposition decision. These documents are typically finalized or in steady state already.

To use this feature, set the Item Requirement Copy field to No. When the field is set to Yes or is null, Vault will continue the existing behavior of copying the Item Requirement document for each Batch Disposition.

QMS

Generate Document from Word Formatted OutputAuto-on25R1.2

This release introduces an enhancement to the Generate Document from Formatted Output action. Admins can now select a Formatted Output Template designed in the Microsoft Word (*.docx) file format or the PDF file format.

Vault creates a placeholder document when the Generate Document from Formatted Output action executes and detects that the Formatted Output Template is a Microsoft Word file format. The action’s configuration specifies a field on the record that stores a reference to the generated document. When the formatted output is generated, Vault up-versions the placeholder document to add the formatted output content. Users with the Download Source permission can download the document’s source file. Users with the View Content permission can see and download the document’s viewable rendition.

If the action is executed as a user action, the user who performed the action will see a notification banner indicating that document generation is in progress.

When Admins configure this action using a Microsoft Word Formatted Output Template, they can also optionally define which roles on a record should receive a completion notification when the action is executed as an entry action.

If a user is manually assigned to any of the roles identified, those users receive the completion notification. Manually assigned users are added to a record’s roles using Quality Teams or directly through Sharing Settings. Users assigned to roles automatically using a Dynamic Access Control (DAC) configuration will not receive completion notifications.

If the Formatted Output generation is successful, and the action used a Microsoft Word Formatted Output Template:

• When the action is executed as a user action, Vault sends a completion notification to the initiating user.
• When the action is executed as an entry action, the completion notification is sent to the user that triggered the lifecycle state change and the users manually assigned to the roles in the action’s configuration.

If the Formatted Output generation fails, and the action used a Microsoft Word Formatted Output Template:

• The completion notification includes an error message indicating why the generation failed.
• When the action is executed as a user action, the completion notification is sent to the initiating user and Vault Owners.
• When the action is executed as an entry action, the completion is sent to the user that triggered the lifecycle state change, the Vault Owners, and the users manually assigned to the roles in the action’s configuration.

Completion notifications are not sent when the action is configured to use a PDF Formatted Output Template.

The Generate Document from Formatted Output action now executes as a Vault System account. In addition, when you use a Microsoft Word Formatted Output, the action executes asynchronously. As a result, customers should not configure processes that presume the Formatted Output document exists by the time a subsequent step occurs. This may require a change to existing business processes. Contact your Veeva representative if you require assistance assessing whether this impacts your processes and how to make the proper adjustments.

Supporting Records: Inspector RoleAuto-on25R1.2

The Supporting Records functionality of Audit Room has been updated to provide greater control over, and finer granularity of, access to records shared with Inspectors without impact to user communities leveraging the Viewer role for record access. With this release, all Supporting Records functionality will now leverage the Inspector (inspector__v) lifecycle application role in all aspects where it previously leveraged the Viewer (viewer__v) lifecycle application role. Only objects that have the Inspector application role added to their lifecycles can have their records shared with Inspectors. Sharing these records with Inspectors will respect atomic security configurations such that only specific fields and sections authorized in the record’s current lifecycle state are made visible to the Inspector.

Recurrence Check Insights: Associated Related RecordsAuto-on25R1.2

Building on the existing Recurrence Check Insights functionality, which allows users to view and create Investigations, CAPAs, and Effectiveness Checks directly on the source record, in this release we’re introducing the ability to link pre-existing records from the Recurrence Check Insights page.

With the appropriate permissions, users can now select multiple existing Investigations, CAPAs, and Effectiveness Checks and relate them to the source record. Once selections are made, the new Relate to Source button becomes active for usage. After the relationships are successfully created, the newly linked records will appear under the related items section of the source record.

Learn more about Recurrence Check Insights and how to configure it in Vault Help.

Duplicate Check Expansion: Complaint Intake, SCN, QIConfiguration25R1.2

This release expands our investment in the Duplicate Check functionality of QMS, introducing support for the standard Complaint Intake, Supplier Change Notification, and Quality Intake objects. Organizations can now keep teams focused on processing unique inbound records, identifying flagging, and short-circuit filing these inbound records before spending key resources triaging and investigating issues that have already been raised and processed.

See Configuring Duplicate Checks for the full list of standard supported QMS objects.

Reason for Change: Print Record SupportAuto-on25R1.2

With this release, we’re expanding on the Print Record feature, with newly introduced support for the Reason for Change application controls on the Reason for Change Details object and any objects leveraging the Reason for Change feature. Printed records with changes tracked via the Reason for Change feature and the Change History section present on their layouts will now include the Change History section with the tracked value changes and details about the changes in a clear, human-readable format. If a more detailed examination is required for an individual change event for which a reason was captured, the associated Reason for Change Details records can now be individually printed, which provides additional metadata related to those specific change operations with full support for the application controls available to their page layouts.

See Providing a Reason for Change for the full description of functions and supported objects.

Quality Teams API Permission EnhancementsAuto-on25R1.2

In this release, we’ve updated the public Quality Teams API endpoints and the Quality Teams Bulk Management feature to no longer require Quality Team Admin permissions. Designated end-users can now perform bulk update tasks securely and efficiently, without the risk of making unintended configuration changes. 

Learn more about the developer-facing functionality of this feature.

Related Record Configurations: Hide invalid Target Fields in Field MappingsAuto-on25R1.2

This release introduces enhancements to the Admin experience when setting up Related Record Configurations, aimed at reducing errors and making configuration setup more intuitive.

When you define Field Value Mappings in a new configuration, system-managed fields, lookups, and inactive fields are now excluded from the list of selectable source and target fields. Additionally, incompatible text fields are not available for selection, for example, when the source field has a maximum length of 100 characters while the target field allows only ten (10). If any configuration error is encountered, the system displays a clear error message upon saving, which helps prevent misconfigurations.

5 Whys Analysis: User Experience ImprovementsAuto-on25R1.2

The 5 Whys Analysis tool has been upgraded to deliver a more seamless and intuitive experience when you edit and save Why Cards. The fields are unavailable while the card is saving, and a Saved indicator is displayed until a new change is made.

Related Event App Section: User Interface ModificationsAuto-on25R1.2

The Related Event Application section for Quality Events (both standalone and as part of the Quality Event object) has been updated to provide more clarity and better guidance to users. It no longer permits partial records to be created and no longer is displayed if users do not have permissions assigned to view any of the records that could be displayed within the section.

Reason for Change: Expanded Support for Standard ObjectsConfiguration25R1.2

The Reason for Change feature became available with the 24R3 release. Veeva introduced the feature to address requirements from health authorities to capture why organizations update certain data fields on completed records. This release expands the supported QMS standard objects for this feature to include the following objects:

• Assessment Risk (fmea_risk_event__v)
• Assessments (fmea_risk_assessments__v)
• Assessment Risk Mitigation (assessment_risk_mitigation__v)
• Severity (severity__v)
• Occurrence (occurrence__v)
• Detectability (detectability__v)
• Risk Matrix (risk_matrix__v)
• Risk Level (risk_level__v)
• Criticality (criticality_level__v)
• Organization (qms_organization__qdm)
• Auditor Profile (auditory_profile__v)
• Auditor Role (auditor_role__v)
• Context (context__qdm)

See Configuring Reason for Change for the full list of standard supported QMS objects.

QMS Standard Application EnhancementsAuto-on25R1.2

This feature includes the following enhancements to the standard Veeva QMS application.

Standard QMS Objects

Veeva aligns standard objects with the applications they support. This ensures that licensed users can fully access all the objects needed to utilize a Veeva application. It also prevents users from seeing unnecessary objects not included in a Veeva application. 

This release updates several standard objects to ensure they are accessible to users of the Veeva QMS application. Please refer to the 25R2 Quality Data Model Documentation spreadsheet for more details. This document will be published to the Veeva QMS Connect community before the 25R2 release.

Standard Layout for the Related Event Object

The Related Event object displays details about a source record’s related record, including the nature of the relationship. This release introduces a standard best-practice layout for the Related Event object, including layout rules that control how the information is displayed. The standard layout is inactive and cannot be modified, but customers can copy it in their own Vaults.

Standard Document Types, Document Fields, and Lifecycle for Generated QMS Documents

The Veeva QMS application includes features that automatically generate documents from information in QMS records. This release introduces standard document types, fields, and a lifecycle for QMS-generated documents. Adding these standard components benefits Veeva QMS customers who use Veeva QualityDocs by eliminating the need to modify QualityDocs configurations to accommodate QMS-generated documents.

Standard Document Lifecycle

This release introduces the QMS Generated (qms_generated__v) standard lifecycle. The lifecycle is inactive by default but can be made active by an administrator.

Standard Document Type

This release introduces the QMS Generated Document (qms_generated_document__v) standard document type, which includes standard subtypes and classifications for Quality Events, Audits, Issue Escalations, and SCAR processes. Please refer to the 25R2 Quality Data Model Documentation spreadsheet for more details. This document will be published to the Veeva QMS Connect community before the 25R2 release.

The new standard document type, subtypes, and classifications use the QMS Generated standard lifecycle. They are inactive by default, but can be made active by an administrator.

Standard Document Fields

Relating a QMS Generated Document to its source QMS record requires a field on the document. The features that generate a QMS document automatically populate the generated document’s field with a reference that points back to the source QMS record. This release introduces standard, shared document fields used by the QMS Generated Document’s subtypes and classifications to store this relationship. All of the fields are inactive by default but can be made active by an Admin. Please refer to the 25R2 Quality Data Model Documentation spreadsheet for more details. This document will be published to the Veeva QMS Connect community before the 25R2 release.

Standard Object Fields for QMS Generated Documents

Relating a source QMS record to a QMS Generated Document requires a field on the QMS record. The features that generate a QMS document automatically populate the source record’s field with a reference that points to the QMS Generated Document. This release introduces standard fields on standard QMS objects to store this relationship. All of the fields are inactive by default but can be made active by an administrator. Please refer to the 25R2 Quality Data Model Documentation spreadsheet for more details. This document will be published to the Veeva QMS Connect community ahead of the 25R2 release.

Standard Organization Field for QMS Processes

Many standard QMS processes use the Organization object to identify a record’s Owning Facility. This release defines a standard Owning Facility field for several standard QMS objects. Please refer to the 25R2 Quality Data Model Documentation spreadsheet for more details. This document will be published to the Veeva QMS Connect community before the 25R2 release.

Standard Simple Join Objects to Relate QMS Processes to Documents

When customers need to create references from a QMS record to a document, they often make a custom object containing a document reference field. Vault governs the number of custom inbound relationships to a document for performance reasons. Therefore, this release introduces several standard simple join objects to relate standard QMS processes to documents. This helps customer Vaults remain performant by eliminating the need to create custom relationships that are commonly needed. Please refer to the 25R2 Quality Data Model Documentation spreadsheet for more details. This document will be published to the Veeva QMS Connect community before the 25R2 release.

Increase the Length of the Veeva Quality Study Protocol Title Field

This release increases the Veeva Quality Study (study__v) object’s Protocol Title (protocol_title__v) field from 128 characters to 500 characters. This field is populated by the Clinical Operations to Quality Connection using data from the Veeva Clinical Protocol Title field, which allows 500 characters.

APQR ProgramsConfiguration25R1.3

The Annual Product Quality Review (APQR) is a critical annual assessment of a drug product’s quality standards. It evaluates whether changes are needed in product specifications, manufacturing processes, or control procedures.

With this release, customers can now leverage a standardized data model set to initiate, plan, and approve APQR programs for a defined period. Once an APQR program is activated, APQR records are automatically generated from proposed APQRs. As execution progresses, the system updates the proposed APQRs to track alignment with the approved plan. 

These APQR programs can be generated using a previously created and approved APQR Program Template.

Once the action is executed, the user will be notified that the creation is complete, and Vault will generate the APQR Program record. When the proposed APQR reaches its start date, a system action will automatically run in the background to generate the APQR, provided that the proposed APQR is in a lifecycle state assigned to the Approved lifecycle state type.

Qualification & Organization HistoryConfiguration25R1.3

This release introduces the ability to create a point-in-time snapshot of data in Organization and Qualification records. This enables customers to capture the historical context of an Organization record when it is approved, and each time it is reapproved after an update. Likewise, it is now possible to store the history of a Qualification record after an initial qualification, and each time a requalification occurs. 

Users can easily see each historical snapshot of an Organization or Qualification record. This can be useful in situations such as an audit when an auditor requests information about Organization or Qualification records at different points during their lifetime.

Clicking on an entry in this section will display the record’s field data when the snapshot was created.

Each record’s snapshot is stored as a document in the Quality Vault and classified using one of the following new standard document hierarchies:

Object	Document Type	Document Subtype	Document Classification
Organization	QMS Generated	Supplier Quality Management	Organization History
Qualification	QMS Generated	Supplier Quality Management	Qualification History

This feature requires configuration by a system administrator. Customers can enable the creation of Organization and Qualification record snapshots using lifecycle state entry actions and user actions. The data included in record snapshots, and the manner in which the data is formatted, are configurable using the Formatted Output feature. Formatted Output configurations should generate record snapshots in read-only PDF format. System administrators should also configure security for Organization History and Qualification History documents to prevent users from editing their content and metadata.

QMS Email Processors: Email Thread DetectionConfiguration25R1.3

The Veeva QMS application can create Complaint, Complaint Intake, and Supplier Change Notification records from emails sent to a Vault Email Inbox. Vault saves a record of each email it receives, creates an associated QMS record, and relates it to the email. 

This feature enhances how follow-up emails about a QMS record, created from a previous email, are handled when forwarded to a Vault Email Inbox. Individuals send follow-up emails to provide additional information not included in their original email. Before this enhancement, each forwarded follow-up email caused Vault to create a new QMS record. However, customers typically want the forwarded emails related to the QMS record created from the original email. 

Customers typically use corporate email inboxes to forward emails to a Vault Email Inbox. The corporate email system filters out unwanted emails, preventing the creation of unnecessary QMS records. Below is an example of how a QMS customer named Verteo uses corporate email inboxes with Vault Email Inboxes.

Corporate Email System Inbox	Purpose of Corporate Email System Inbox
complaints@verteo.com	Verteo set up this corporate email inbox to receive emails from patients and healthcare providers about potential Product Quality Complaints. Emails received in this corporate email inbox are automatically forwarded to complaint-intake@verteo-vault-prod.com, the email address associated with Verteo’s Vault Email Inbox that creates Complaint Intake records.
supplier-change@verteo.com	Verteo set up this corporate email inbox to receive emails from Verteo’s suppliers describing proposed changes to materials and processes.Emails received in this corporate email inbox are automatically forwarded to scn@verteo-vault-prod.com, the email address associated with Verteo’s Vault Email Inbox that creates Supplier Change Notice records.

Emails received into these corporate email inboxes pass through a junk email filter, and the remaining emails automatically forward to the appropriate Vault Email Inbox through auto-forwarding rules set up on the corporate email inbox. Before this release, the forwarded follow-up emails created new Complaint Intake and Supplier Change Notification records rather than relating the follow-up emails to existing QMS records.

This release introduces a new configuration option called Email Thread Detection. When set to Root Message ID, this option allows a Vault Email Inbox to identify a forwarded follow-up email’s thread. Vault uses the email thread to locate the original email and the associated QMS record. It then relates the forwarded follow-up email to the QMS record. This configuration option prevents Vault from creating a new QMS record for each forwarded follow-up email. The diagram below illustrates how this works using an example of a corporate email inbox that receives complaint emails and sends them on to a Vault Email Inbox for Complaints.

When Email Thread Detection is set to Match on Root Message ID on the Complaint Vault Email Inbox, forwarding the reply to the original complaint email causes Vault to relate the reply email to the Complaint Intake record rather than creating a new Complaint Intake record. The new Email Thread Detection option is shown below on the screen that system administrators use to configure a Vault Email Inbox.

When the Email Thread Detection option is set to Match on Message ID, replies to the original email forwarded to the Vault Email Inbox create a new QMS record. Match on Message ID was the default setting before this release and will be the Email Thread Detection option selected in all existing email processors in QMS Vaults after this release. For customers who exchange email messages once the original email has been forwarded to Vault, and want those emails to be associated with the original record created from the email, we recommend selecting Match on Root Message ID instead.

Learn more about how a Vault Email Inbox creates Complaint, Complaint Intake, and Supplier Change Notification records.

QMS Change Related Object Lifecycle State Enhancements and Expansionimages25R1.3

In 24R2, we introduced the QMS Change Related Object Lifecycle State action for the Audit Program and FMEA Risk Assessment objects. This action executes an asynchronous job without record limits, enabling the transition of related object lifecycle states beyond the 1,000 record cap of the synchronous version. It also allows the primary object to proceed to a defined state if some related records encounter errors during their state transitions.

In this release, we are expanding support for this asynchronous action to the following objects: Quality Event, Change Control, Complaint, Continuous Improvement, Deviation, Finding, Lab Investigation, and Nonconformance. Additionally, administrators can now configure which record roles should be notified upon completion of the action.

QRM: Probability Support for Hazard - Harm AnalysisConfiguration25R1.3

In support of ISO 14971, the Risk Matrix can now support definitions for the Probability of a Hazardous Situation (P1) and the Probability of Harm (P2) resulting from such a situation. These values can now be configured as part of a Risk Matrix, via the Dimensions picklist field’s new entry for Severity, Probability, Occurrence, to be part of the calculation of overall criticality scoring of risks.

The Risk Builder has also received updates to enable assessors to properly denote both P1 and P2 as part of their risks.

Both Risk Matrices and Risk Assessments have also received new updates to standard layouts for organizations to reference when adopting this feature.

QRM Enhancements: Reorder Risks, Heat Map OrderingAuto-on25R1.3

This release introduces several major changes to the user experience of working with risks. Prior to this release, if you wished to leverage risk ordering and needed to change the order of existing risks, you needed to open both risks (or all affected risks) in the Record Details view and change the Risk Order field manually for each. With the new Reorder functionality available in Risk Builder, you can now drag and drop risks into your preferred order.

In the event that the type of risks being managed are part of logical groupings (like FMEA), the intuitive UI allows simple gestures to reorder within those groups. As a consideration, with this change to automatic numbering, changing the Process Step (or logical grouping) of an existing risk with the Risk Order field will result in the risk’s new Risk Order being set to zero (0). This ensures that the risk is easy to find in the new structure for assessors to reorder, since changes to Process Steps may have dramatic impacts on the risk order in both the source and destination Process Steps’ existing risks.

Additionally, for organizations working with Risk Heat Maps, we’ve improved the readability of generated heat maps by reordering the Y-axis of 2D and 3D heat maps, so that the most critical entries are displayed at the top of the map. This reordering is automatically applied to all heat maps generated (or regenerated) after the release.

Field Corrective Action EnhancementsConfiguration25R1.3

The Field Corrective Actions management solution within Veeva QMS has received several major functional improvements this release, with the ability to send tracked Safety Notices as a new type of Product Action, and support for configurable Email From addresses similar to those available for managing Complaints.

Safety Notices are perfect for situations when Owners require notification but do not require returning specific medical devices. These notices are tracked, similarly to External Notification’s tracked emails, and support Email From configuration so that organizations can be aware of any send or delivery failures. 

Additionally, Product / Material Tracking around FCA-Lot records has been updated and simplified for Product Return and Service Request actions. Both types of actions now support automation around identifying FCA-Lot records that are not in their completed state. For external Consignees, Vault will create or update Product / Material Tracking records for FCA-Lot records with either Product Return or Service Request actions indicated. For internal Consignees of either type of action, Containment records will be created automatically. This automation will skip FCA-Lot records that have no indicated action.

Quality Teams: Advanced User SearchAuto-on25R1.3

In previous releases, the Quality Teams user selection drop-down displayed only user names, making it challenging to differentiate between users with identical names, especially in organizations with large user bases or those not using filters such as Constraining Roles or Exclusive Membership.

With this release, we’ve introduced an advanced search dialog, accessible via the binoculars icon, to enhance the team member selection experience. This new dialog allows users to search and select team members based on additional user metadata, improving accuracy and usability.

Exclusive Membership and Constraining Roles filters are applied to the search results. However, if a Constraining Role exceeds 10,000 users, the search dialog does not apply the Constraining Role filtering.  In this case, the user is prevented from adding invalid selections.

Learn more about working with Quality Teams in Vault Help.

Recurrence Check: Add Criteria VQL for Related Objectsimages25R1.3

In this release, we have enhanced the Quality Record Checks configuration capabilities by introducing Criteria VQL support for each related object. Admins can now apply additional filtering rules to refine the match criteria for related objects.

This is especially useful in scenarios where users are looking for recurrences based on specific field values or other criteria on the related objects, offering greater precision and control over recurrence detection.

Learn more about creating Quality Record Checks in Vault Help.

Recurrence Check: Record Check Result Object ControlConfiguration25R1.3

In this release, we have introduced a new object control that Admins can add to the page layout of the Record Check Result object. This control is designed to replace the existing Filters, Fields Searched, and Matching Search Terms fields. It also supports the Print Record (Download to PDF) feature, providing a more streamlined and consistent user experience.

Auditor Profile: Delete User Role Setup when Role Qualification Status is DeletedConfiguration25R1.3

Starting with this release, the User Role Setup record associated with a User will now be automatically deleted when the corresponding Auditor Role is removed.

Learn more about Auditor Profiles in Vault Help.

Reason for Change: ExpansionConfiguration25R1.3

This release introduces Reason for Change support for the Context (context__v) object, allowing organizations using that object to have better controls over data changes for individual Context records. 

Learn more about setting up the capture requirements for Reason for Change in Vault Help.

QMS, Quality

Organization Data Model EnhancementsAuto-on25R1.3

This release brings a significant enhancement to how organizational data is modeled and managed, with the introduction of new purpose-built objects, in addition to the already existing ones, designed to support greater flexibility and long-term scalability.

These new objects provide a more structured approach to representing internal and external entities, allowing for clear differentiation and reducing complexity in how organizational relationships are managed. By moving beyond a one-size-fits-all model, customers can now design more intuitive and scalable architectures that better reflect the real-world structures.

With this enhancement, a cleaner data model and reduced dependency on custom relationships are achieved. This new framework not only supports evolving business needs but also provides a strong foundation for future growth, making it easier to maintain and extend the system as organizational complexity increases.

Learn more about the organizational data model in the Data Model Documentation in Vault Connect.

QMS, Surveillance

QMS, VPS: Reportability for Domestic vs Foreign IncidentsAuto-on25R1.2

Veeva Product Surveillance and QMS customers working with Reportability Assessment decisions can now support different durations for how long an organization has to report Incidents that happen in-country versus those that happen out of country. Prior to this release, organizations had to manually track the difference in allowable timelines to complete the reporting process. With this release, the Reporting Requirement picklist has been updated with the Country of Incident picklist value label changing to Domestic Incidents, and a new entry introduced supporting Foreign Incidents. Organizations already leveraging reportability requirements do not need to take action to handle existing reportability rules that previously used the Country of Incident value. Organizations may now add a row to their reportability configurations to define the duration to be used for Foreign Incidents. Organizations working with reportability requirements that leverage the same duration for Domestic Incidents and Foreign Incidents can still leverage the Global Incidents option.

Surveillance

VPS: Consolidation of Complaint DetailsAuto-on25R1.2

In an effort to simplify data storage, access, and reportability models within Veeva Product Surveillance, Vault will no longer split device related additional Complaint Details across the Complaint Details and MedTech Complaint Details objects. Vault instead will streamline all additional Complaint Details in standardized mappings to the Complaint and Adverse Event objects. Existing record data stored in Medtech Complaint Details object records will be preserved there, but all newly captured data for Complaint records that do not have an associated Medtech Complaint Details record will instead be captured in the new model.

VPS: AER ConfigurabilityConfiguration25R1.2

This release introduces the VPS: Adverse Event Report Configurations component for Admins, providing greater controls for organizations looking to manage how users interact with various parts of the adverse event reporting experience, per report type. This allows control over how users directly update source records as a part of working with Adverse Event Reports, or prohibit that behavior and instead require users to consciously access the source records and make source data changes there directly. For example, prior to this release, if a user had the permissions assigned  to edit a Complaint’s metadata, was working on an AER, and went to change a data field that was stored on the Complaint, Vault would automatically replicate that change directly to the Complaint record. With the new component, Admins can now determine, per report type, to opt-out of that automatic data exchange between changes to the AER and underlying objects.

VPS: Japan AE Reporting - Custom UI EnhancementsAuto-on25R1.3

In support of Japan PMDA reports within Veeva QMS’s MedTech Adverse Event Report management solution, several enhancements have been made to the Adverse Event Report workflow’s UI to ensure various codes are easier to manage and work with. 

Changes have been introduced to the management of Health Effect Codes, Device Problem Codes, Component Codes, and Investigation Codes. Each of these areas of the Adverse Event Report experience have been updated to guide users to select codes from appropriate coding glossaries and to enforce dependencies for second-level codes where applicable.

Investigation Codes have received additional treatments to ensure that selection of the Type of Investigation Code drives the options available for the Finding Codes and their subcodes, as well as the Investigation Conclusion Code’s subcodes.

These changes aim to make the experience streamlined and significantly reduce errors in code selection when building an Adverse Event Report.

VPS: Japan AE Reporting - Health Authority ValidationsAuto-on25R1.3

This release introduces automatic field validations for over 50 fields represented in the Japan PMDA-submittable Adverse Event Report. These validations appear inline with the fields they apply to in the Vault UI, just like the existing support for the FDA eMDR and EU MIR Adverse Event Reports. Prior to this release, organizations had to generate the XML file for their Adverse Event Reports and attempt submission to understand if there were any missing or inappropriately formatted values in their submission.   

These validations are immediately available without configuration for all Japan PMDA-submittable Adverse Event Reports.

VPS: Product Master Data AutomationConfiguration25R1.3

This release introduces a new application setting for several types of Adverse Event Reports managed in Veeva QMS. The ​Use Regional Product Attributes option is for organizations who require country-specific or region-specific product attributes, such as the Brand Name, Common Device Name, and Device Description, for FDA eMDR, EU MIR, Health Canada, and Japan PMDA Adverse Event Reports, and is available on a per-report-type basis.

If enabled, new entries will be added to the Adverse Event Report form representing the region-specific versions of metadata, sourced from a master data set governed by your organization. The regional data will be automatically selected from matching rows of the Regional Product Attributes object against the specified data on the underlying Complaint.

This flag is optional, and the behavior of your product data mappings within the Veeva QMS Adverse Event Report solution will not be affected unless it is enabled for that specific type of Adverse Event Report.

VPS: Adverse Event Report ImprovementsConfiguration25R1.3

Section D9 of the FDA eMDR Adverse Event Report has been updated with this release to more clearly store values based on users’ responses for Device Available for Evaluation. Specifically, for values of Destroyed or No, the field will be uniformly set to No. For values of Returned to Manufacturer/Importer or Yes, the field will be uniformly set to Yes. The field will be blank for all other selected values.

This change is effective upon the next save of any changed eMDR.

QualityDocs

Prevent Selection of Proposed Implementation Date Field in the PastAuto-on25R1.2

This enhancement prevents users from selecting a date in the past for the Proposed Implementation Date field on the Document Change Control object. When configured, Vault copies the Proposed Implementation Date to relevant document fields when the Update Change Control Document entry action runs. The date controls when the respective documents become effective/obsolete when the Auto-effectivity or Auto-obsolescence jobs run. This feature helps prevent unexpected effectivity and obsolescence caused by human error. When a user attempts to save a record with a past Proposed Implementation Date, Vault displays an error message:

Associate Document Change Request & Periodic Review Records during Change Authorizationimages25R1.2

When using the Change Authorization section of the Document Change Control process, users can manually or automatically associate Document Change Request and Periodic Review records related to the Target Documents of the Change Authorization records. This provides Impact Assessors and Change Authorization Approvers with additional reference and context for the proposed changes to the documents included on the Document Change Control when completing their respective tasks. Prior to this enhancement, it was only possible to associate Document Change Request and Periodic Review records once the Document Change Control had already received Change Authorization Approval.

Hovercard in the Associated Documents Panel in Process Navigatorimages25R1.2

Hovering over a document in the Associated Documents panel in Process Navigator displays a standard document hovercard that enables users to quickly view a document thumbnail and additional document information such as document title, type, subtype, and last modified information. This can be especially useful in Vaults where a document’s Name may be numerical or non-descriptive.

Prevent Duplicate Documents in Process NavigatorAuto-on25R1.2

When users attempt to add a Hierarchy Document record with the same source document that has already been added via another Hierarchy Document record on the same Visual Hierarchy record, Vault displays an error:

Allow Deletion of Documents with Inactive Controlled CopiesAuto-on25R1.3

In the 24R2 release, a feature was introduced so that Vault would no longer prevent users from deleting a document with one or more associated Controlled Copy Trace records. This enhancement further refines this feature by ensuring that documents with associated Controlled Copy Trace records can still be deleted, but only when all of the associated records are in an inactive state. When enabled, a new application setting allows Vault to automatically delete inactive Controlled Copy Trace and active and inactive Controlled Copy User Input records when the associated target document is deleted.

Dynamic Association of Process Navigator DocumentsConfiguration25R1.3

Process Navigator can now dynamically populate the list of documents associated with a given process based on configured matching rules. Prior to this release, Process or Document Owners were only able to associate documents manually via the document Quality Relationship panel or the Process Navigator Homepage. This manual association often requires a significant amount of ongoing Process Owner maintenance.

With this new feature, Process Owners are able to invoke a new user action called Document Association Criteria from a given process. Process Owners with the appropriate create permissions are able to configure up to three matching rules per process, on which the system executes using an OR logic. These matching rules can be created per Document Type (required), Subtype (optional) and Classification (optional) as desired. After configuring the matching rules, Process Owners also have the option to edit the rules or preview the list of documents that are automatically matched by the system.  

Under each matching rule, Process Owners can leverage multiple document fields to build matching criteria. The selection of document fields that Process Owners can use are predefined by Admins. Admins can define up to ten document fields of the below types: Boolean, Object Reference, or Picklist. 

For customers who have associated documents to processes manually, Vault resolves any duplicates between the dynamically-generated list and the manual list before displaying them in alphabetical order. This list of associated documents is displayed in the Associated Documents panel of the Process Navigator Landing Page and the documents section of the Process Navigator Detail Page. The current limit of 200 documents per process will be honored. When there are more than 200 documents, a warning banner with “Only the first 200 documents will be displayed” shows on the associated document panel.

Document Control Homepage Enhancementimages25R1.3

Documents in Superseded and Obsolete statuses do not undergo Periodic Reviews but, depending on configurations, these documents may have a Start Periodic Review Date field value. The Documents with Upcoming Periodic Reviews section on the Document Control Homepage no longer displays documents in Superseded or Obsolete states.

Quality Relationships Panel Enhancementimages25R1.3

In the Document Relationships section of the Quality Relationships panel, a new System Managed Relationships subsection displays standard relationships that are automatically created by Vault, such as Based On, Original Source, and Linked Documents. This helps to distinguish these types of relationships from those which are created by users and appear under the existing Target and Source subsections.

QualityDocs, Training

Automated Generation of Training Requirement Impact Assessment (TRIA) & Display in Document Change Control (DCC)Configuration25R1.2

In this change, new configuration components allow Vault Admins to combine QualityDocs and Training’s Document Change Control (DCC) and Training Requirement Impact Assessment (TRIA) processes.

Prior to this change, these two processes were disconnected, and TRIA could only be triggered once a document reached the Approved state during the DCC process.

The main goals of this change are to:

• Complete the TRIA process before the document reaches the Issued (Ready for Training) state, so that Learners have more time to train on the document before it becomes Effective (reaches its Steady state). Similarly, this process ensures Learners are not prompted to train on documents which are going to be made Obsolete.
• Allow Document Controllers to be included in the TRIA process.
• Increase visibility to both processes by linking DCC and TRIA records.

For example, once Vault starts the DCC Impact Assessment workflow and transitions the DCC record to the In Document Review state, a new DCC lifecycle entry action also creates TRIA record(s) for the DCC’s documents to be made Effective or Obsolete. Additionally, Vault assigns DCC process participants TRIA workflow tasks (according to their assigned roles on the DCC record), and a new Entry Criteria ensures that the DCC can only be closed when all related TRIA workflows are complete.

Training

Facilitated Training: Training Assignment Completion for Superseded DocumentsConfiguration25R1.2

This Facilitated Training enhancement allows Training Admins to complete cancelled Training Assignments for superseded documents. This is useful in larger organizations where Learners complete training outside of Vault, then Training Admins log the history in Vault on their behalf. This process takes time, during which the associated documents could become superseded and thus cancel the related Training Assignments. 

With a new Cancelled Training Assignment page layout section on the Facilitated Training Request object types for Curricula and Training Requirements, Training Admins can review and select cancelled Training Assignment records and their associated documents within the related Training Content Set. When the Facilitated Training Request record moves to a lifecycle state where the Update Training Assignments entry action is configured, the Facilitated Training async job moves these cancelled assignments to the Completed state.

Equivalency Substitute Training RulesConfiguration25R1.3

This feature introduces Equivalent Training Rules, where a primary Training Requirement (or one that is part of the Learner’s current Training Matrix) can be indicated as equivalent to another primary requirement: When a Learner completes training for an equivalent, they receive credit for both, as shown in Use Case 1 below. Equivalency can also be bi-directional, where the configured rules allow the Learner to complete either primary requirement and receive credit for both, per Use Case 2.

This feature also improves upon existing Substitute Training Rule functionality, enabling a new use case where a primary Training Requirement can be indicated as a substitute for another primary requirement. Previously, a primary Training Requirement could only be substituted by a requirement outside of the Learner’s matrix. In contrast to equivalent rules, Substitute Training Rules cannot be made bi-directional: In the case of two requirements (primary or non-primary), only one can be substituted for the other. This new capability can be seen in Use Case 3.

With a new Training Rule Substitution Type picklist, Training Admins select the Full option to completely “swap” one primary requirement for another when creating a Substitute Training Rule. Other picklist values support this feature’s accompanying Delta Training and Refresher Training features.

Use Case 1: Simple Equivalent Rule

A Learner’s Training Matrix includes two Training Requirements on the topic of gowning: One for an instructor-led training (ILT) and another for the Learner to independently read and affirm understanding of a training document (R&U). Though the “Gowning ILT” is more in-depth than the R\&U training, Learners are currently required to complete assignments for both, as they are based on primary Training Requirements (any requirement in their Training Matrix).

With this feature, a Training Admin can configure a training rule on the “Gowning R&U” requirement such that “Gowning ILT” is considered to be its equivalent. This means the Learner can attend only the ILT session on gowning (in lieu of reading the training document) and automatically satisfy the “Gowning R&U” assignment while remaining in compliance with their Training Matrix.

Use Case 2: Bi-Directional Equivalent Rules

The “Gowning R&U” requirement and related Training Materials are up for biennial review. During the review, a “Gowning ILT” instructor notifies the Training Admin that the “Gowning R&U” requirement’s updated materials now match the depth of content covered in the ILT session, and that these requirements are now equivalent to each other.

To accommodate this within the Training Matrix, the Training Admin configures a second training rule such that the “Gowning R&U” is considered to be the equivalent of “Gowning ILT”. This new rule can be configured on either requirement, as Vault ensures any configured training rules are visible within all impacted requirements.

Together, the rules described above make the equivalency relationship bi-directional: Learners can now complete either the “Gowning R&U” or the “Gowning ILT” assignment and satisfy the one they did not complete.

Use Case 3: Bi-Directional Equivalent Rules with a Full Substitute

As part of the “Gowning R&U” requirement’s biennial review described above, the requirement’s new English-language Training Materials were translated into Spanish, and those materials are now part of a new “Gowning R&U - Spanish” requirement. This new requirement supports a use case of the existing Substitutes feature, where Vault can dynamically assign training based on a Learner’s locale.

The Equivalency Substitute Training Rules feature allows a Training Admin to apply basic substitute behavior to more complex situations such as bi-directional equivalency: With a third training rule for this group of requirements, Learners opting to complete the “Gowning R&U” are automatically assigned “Gowning R&U Spanish” when their Person record’s Language is “Spanish”. This English-Spanish “swap” is considered to be a full substitution; see Delta Training and Refresher Training for other substitution types.

Delta TrainingConfiguration25R1.3

Delta Training enables organizations to develop shorter training materials focused on delta training content (changes between document versions) then assign them to Learners who have previously completed an assignment for that requirement. This reduces training time and improves knowledge retention, as these Learners are only required to understand the latest round of updates.

Prior to Delta Training, any re-training as a result of recurrence required Learners to re-train on all training materials, even for minor process updates. Delta Training allows a Training Admin to, for example, send Learners a brief PowerPoint presentation covering only the latest updates to the Gowning Standard Operating Procedure (SOP). See the use case below for an example of how this appears within a Training Matrix.

Use Case: Single Equivalent Rule with a Delta Substitute

Learners assigned the “Gowning R&U” Training Requirement via their Training Matrix (a primary Training Requirement) are able to complete the “Gowning R&U Delta” requirement in lieu of the full set of materials contained within the primary requirement for which they previously completed training, for example as part of their new-hire training. 

This example of a Delta Substitute Rule is similar to another use case shown for this release’s Equivalency Substitute Training Rules feature: For Use Case 3, Vault provides full English training materials for Spanish ones in certain cases (a Full Substitute Rule). Here, a Delta Substitute Rule enables Vault to instead provide the delta materials when assigning training for the “Gowning R&U” requirement. See the Equivalency Substitute Training Rules feature for more information on how the “Gowning ILT” requirement can satisfy “Gowning R&U”.

Refresher TrainingConfiguration25R1.3

Refresher Training enables organizations to develop shorter training materials focused on refreshing or “renewing” a Learner’s knowledge on the most important aspects of a requirement in their Training Matrix (a primary Training Requirement). Vault issues these specialized materials using a Training Admin-configured Refresher Substitute Rule: When a primary requirement recurs, Vault substitutes the refresher content for the primary requirement’s content for any Learner who has previously trained on that requirement.

For example, a Vault Document Training Requirement for a particular SOP recurs every two years, relative to the last time a Learner completed an assignment for that requirement. When this requirement is configured with a Refresher Substitute Rule, Vault assigns the refresher requirement’s content to Learners, in lieu of the primary requirement’s Training Materials. This reduces training time and improves knowledge retention, as Learners are only required to focus on the refresher-oriented content.

LearnGxP ContentDirect: Learner Homepage Course ImagesSupport25R1.3

The goal of this new feature is to allow displaying images for LearnGxP Training Requirements on Learner Homepage cards. Previously, Training Admins were required to manually upload the image. Displaying images helps Learners easily identify the course and saves Admin maintenance time. 

When enabled in LearnGxP ContentDirect, subscriber Vaults automatically pull images along with SCORM content. Consequently, when Vault auto-creates Training Requirements, the related job automatically associates relevant images with the course to display on the Learner Homepage.

Automatic Completion Credit for Document ParticipantsAuto-on25R1.3

In certain scenarios, document participants (for example, Owners or Approvers) do not need to complete training for the documents they worked on. This feature allows Training Admins to automatically grant training credit to these select document participants.

Vault Admins can configure the Provide Participant Training Completion Credit system action within a document or a document change control (DCC) workflow. They can select one or more participant groups in that workflow to grant the automated credits. When Vault issues training for that document’s Training Requirement, it automatically completes related assignments for these participants.

An Admin can also configure a section on the Training Requirement Impact Assessment (TRIA) object page layout (“Training Completion Credit Users”) which displays all the Learners for whom Vault will grant automatic credit when issuing related assignments. With this information, Training Admins can modify the list of users. This feature does not support Vault Document Training Requirements with multiple documents. When there are multiple items in the content set associated with a requirement’s latest TRIA, Vault displays a warning message: “This is a multi-item training requirement. Automated participant credit is not currently supported”.

This new feature also allows Training Admins to determine whether automated completion credit is allowed at a Training Requirement level. They can use a new Allow Document Participant Credit? field on the requirement to specify whether that requirement should be processed with automated credit. This new field also exists on the TRIA object, where the Training Admin can modify the field during their assessment. When either field is modified, Vault synchronizes them.

Auto-on Training & Study Training EnhancementsAuto-on25R1.3

Instructor-Led Training Search Enhancements

Search functionality is improved for multiple Instructor-Led Training sections, including clearing searches when switching between tabs. Additionally, the total count of Learners displayed on the Roster and Waitlist remains the same, regardless of search values.

Quality Relationships Panel: Support for External and Evaluation Training Requirement Types 

On the Quality Relationships panel’s Training Requirements section, there is an Add button that allows the user to select Training Requirements from a dialog. Selected requirements then have the document added to their content set. In the past, this was only applicable to Document and Classroom types, since only those types could contain documents.

Learner Homepage & Task Page: Assignments with Archive Documents

Previously, when viewing a Training Assignment with an archived document, the Learners were presented with an error on the Learner Homepage and on the assignment’s task page. After this enhancement, Learners view an assignment with an Archived document in these locations, Vault informs them that the document is archived.

Learner Home Page: Desktop View Accessible from Mobile

The My Learning Mobile view now contains links for the Open, History, and Explore tabs, which open in a browser tab when selected.

Learner Home Page: Open Training Assignments Count Matches the Filtered Training Assignment Count

In the My Learning > Open tab, the count of Open Training Assignments on the left side bar now updates when a user applies filters. Previously, this number did not automatically update when using a filter.

LIMS

Stability: Quantity Tracking & Pull ProcessAuto-on25R1.3

This release introduces enhanced tracking capabilities for stability studies, allowing organizations to manage product quantities throughout the study duration.

Key Changes:

• New Standard Fields: The system now includes dedicated fields to track:
  • Planned Storage Quantities
  • Actual Quantity Stored
  • Quantity Pulled
  • Quantity Required for Pending Timepoints
  • Remaining Quantity
• Planned Storage and Pull Amounts: As part of the Stability Study Design, track the planned storage quantity and pull quantity for each timepoint per condition and orientation.
• Automated Quantity Updates: As products are pulled for testing the Quantity Pulled, Quantity Remaining, and Quantity Required for Pending Timepoints fields will be automatically updated.
• Inventory Management: Automatically track planned versus actual storage, providing a clear overview of product availability at each timepoint and for each storage condition/orientation. This helps ensure sufficient material is available for testing and potential re-testing or study extensions.

Calculation: Log Function SupportConfiguration25R1.2

This feature adds two new functions when creating formulas/expressions. The log function can be specified with any valid base number (for example, base 10), while the ln function assumes a base number of e for a natural logarithm. 

Create Lab Evaluation Criteria Criteria Records as Part of Test CreationConfiguration25R1.2

Lab Evaluation Criteria records are now only created when the Lab Test (and its Lab Test Results) are created. Previously, Criteria records were created, even if the related Tests were not.

Display Expected Amount and Unit for InputsConfiguration25R1.2

The Test Execution User Interface (UI) now displays the expected amount and units for Inputs.

Stability Study Design and Study: User Interface UpdatesConfiguration25R1.2

The following updates were made to the Study Design and Study Schedule UI:

• The Schedule section label was updated to Tests.
• The Storage Count section label was updated to Storage Quantities.
• The filter panel was updated to account for updated section labels.
• The filter panel now allows the user to jump across sections.

Dynamic Access Control Property is No Longer Editable for Spec Data Criteria SetConfiguration25R1.2

The Dynamic Access Control properties (Custom Sharing Rule and Custom Matching Rule) are no longer editable on the Spec Data Criteria Set object.

Stability Timepoint Export: Use -- instead of N/AConfiguration25R1.2

The Stability Study Timepoint Export feature has been updated to export – instead of N/A if a result is not expected for a Timepoint. In some cases, N/A is a valid result. 

Starting a Test will Stamp the Test Definition on the Test SetConfiguration25R1.2

When a Test Set is created, the Test Definition is now stamped on the Test Set.

System Suitability TestingConfiguration25R1.4

This feature allows an organization to ensure a system (equipment, instrument) is suitable for use, meaning it will provide the expected results and meet criteria before or during sample testing. 

Test Definitions can contain Variations for various Quality Control Sample types (System Suitability Sample, Reference Standard, Blank, and so on). Each Quality Control Sample can have its own acceptance criteria, which is evaluated during test execution. For QC Samples that do not meet criteria, LIMS automatically launches a workflow that allows an authorized user to determine next steps such as invalidating the run or re-testing.

Additionally, this feature allows Test Sets to be invalidated.

Test Definition Operational CriteriaConfiguration25R1.4

This feature allows the definition of Test Set Results (method parameters) for each Test Definition. These results are specific to the entire Test Set and have their own Test Definition Criteria. Set Results are evaluated during test execution and flagged if the result does not meet criteria.

Stability: Pull Window & Pull ComplianceConfiguration25R1.3

This feature allows users to select both early and late pull windows, which can have different values. Currently, the system does not support scenarios where the upper and lower pull windows differ. This update also includes changes to the Review Study Overview UX, applying to both the Study Design and Study sides, to incorporate the early and late pull windows.

Additionally, this feature introduces the ability to track Pull Compliance for Lab Samples, allowing users to monitor whether samples were pulled within the designated pull windows.

Stability: Standardization of Unit of MeasureConfiguration25R1.3

This feature introduces a new standard picklist field on the Unit of Measure object with predefined values. The system now references this picklist for time-based calculations during study initiation. Additionally, it uses the standardized picklist to automatically order timepoints in ascending order, from left to right on both the Study Design UI and Study UI.

Change Analysis Enhancements: Bulk Update References to Latest VersionConfiguration25R1.3

This feature provides an automated way for users to resolve instances where a Spec Data record may be referencing older versions of the Sample Plan or Test Definitions.

Change Analysis Enhancements: Re-merge Change AnalysisConfiguration25R1.3

This feature provides a new user action that can add Change Analysis records to an existing workflow Envelope. Change Analysis records that are already in a workflow cannot be added. 

Change Analysis Enhancements: View DependenciesConfiguration25R1.3

This feature enhances the Re-merge Change Analysis user action by providing a view of other Change Analysis records that are blockers for verification and approval. Change Analysis records that are dependencies and not already in a workflow will be preselected.

Convert Controlling Lookup Fields to Reference FieldsAuto-on25R1.3

This feature was originally introduced in 25R1. It added new standard fields to the data model to address an issue where lookup fields were not updating in time to control dependent fields. 

Previously, this feature needed to be enabled by Veeva Support, which would update all system logic to reference the new fields and facilitate an automatic data migration to populate them. Additional customer-specific configuration is required (for example, layouts, reports, and so on) to completely cutover to the new fields.

As of 25R2, this feature will be automatically enabled in all Vaults. Our teams have worked with you to prepare for this. Reach out to Veeva Support with any questions or requests for additional support.

LIMS: Lab Investigation (Support Quality Event and Test Set)Auto-on25R1.3

This feature expands support for the creation of Lab Investigations within the Quality Event object. Admins may choose between creating standalone Lab Investigations or creating Lab Investigations within the Quality Event object. Additionally, Lab Investigation Requests can be created from the Test Set when issues arise during test execution. 

Simplified Aliquot ConfigurationConfiguration25R1.3

This feature allows a Select Sample action to reference an Aliquot Sample action. This traceability allows samples to be automatically matched to the appropriate select action for a particular aliquot action.

Version History Section for Test Definition-Document RecordsConfiguration25R1.3

For a given Test Definition-Document record, users can now see previous versions of the record.

Update to Revision Behavior on Lab Test Results ExecutionConfiguration25R1.3

This feature updates the logic for setting Revision on Test Results. A revision is not recorded when a calculated result that initially failed is later successfully calculated, or when a manual result with no initial value is later given one.

Remove Unused Data Model and Components from LIMS VaultsAuto-on25R1.2

Certain data models and components that are specific to other Quality applications and not used by LIMS have been removed from all LIMS Vaults.

Lab Criteria Evaluation records are now created when its Test is createdAuto-on25R1.2

Previously,  Lab Criteria Evaluation records were created when the Spec Execution record was initiated, even though Tests were not created. Now, Lab Criteria Evaluation records will only be created when its Tests are created

Display Expected Amount and Unit for InputsAuto-on25R1.2

This update displays the Expected Amount and Unit for Inputs on the Test Execution screen. Previously, this information was not visible to the end user.

Test Set: Enhanced Ways to Search and Select SamplesAuto-on25R1.2

This feature adds the following enhancements to searching for and selecting samples:

Test Execution:

• Added the Sample Select dialog, including a search box, barcode entry, and the ability to filter barcodes
• Updated left panel list of records
• Updated right panel selected records
• Updated dialog name to Sample Set

Sample Results Entry:

• Updated the dialog name to Sample Set

Stability: Study Schedule User Interface EnhancementsAuto-on25R1.2

The Study Schedule UI has been updated for Study Design and Study. The following changes have been made:

• Updated color scheme to align with the rest of LIMS.
• There is a dedicated section for Tests. The Schedule section header was removed.
• The Filter icon was removed.
• The Storage Counts section was removed.
• The left panel is now collapsable.
• The Timepoint Hover Display has been updated.

Data Model: Dynamic Access Control Property is No Longer Editable for Spec Data Criteria SetAuto-on25R1.2

Security on design data objects, which includes Spec Data Criteria Set, is automatic via application security. The Spec Data Criteria Set no longer has configurable security.

Stability Study Export: Use -- instead of N/A for Not Expected ResultsAuto-on25R1.2

For results that are not expected in a stability study, these results are indicated by – in the export file instead of N/A.

Test Set Now Contains the Test Definition It is Associated WithAuto-on25R1.2

When a Test Set is created, the Test Definition is now stamped on the Test Set.

Test generate logic was updated to avoid potential duplicatesAuto-on25R1.2

The system now checks the Generated field value before creating a Test. If it is false, Vault generates Tests. If it is true, Vault does not generate Tests. This avoids a rare race condition where duplicate tests could be created.

Do Not Notify Vault Owners on Design Data Portability File Failed to ImportAuto-on25R1.3

When a Design Data Import job ended with Errors Encountered, Vault Owners formerly received two emails: an “AsyncOperation did not finish successfully” notification and a notification from the job itself containing the details of the issue. The first email is no longer sent.

Initiate Spec Execution can Use Spec Data Mapping Records in the Standard Active StateAuto-on25R1.3

When a Spec Execution is created (when a Batch is logged), the Spec Data that is used is based on the Spec Data Mapping that meets the following conditions:

• Spec Data Mapping records with a status of Active on a custom lifecycle state (pre-existing)
• Spec Data Mapping records with the Standard Active state

Up to 100 Samples' Tests can Now be Added to a Test SetAuto-on25R1.3

A Test Set can now contain up to 100 Tests for various samples.

All Test Set and Lab Test Result Object Records Updated with New Field ValuesAuto-on25R1.3

As part of the System Suitability and Operational Criteria features, the following object records were automatically updated:

• Test Set: Invalid field set to false
• Lab Test Results: Set reference for Step Definition

Lab Location Records that Meet Certain Conditions can be DeletedAuto-on25R1.3

Lab Locations and their associated records can be deleted provided that all of the following conditions are met:

• The Lab Location (or related Location via Hierarchy Change references) has never been assigned to an Asset, Consumable, or Lab Sample.
• The Lab Location’s parent has never changed after initial creation.
• If the Lab Location has children, then all its children must satisfy the aforementioned constraints.

Validation Management

Display Workflow Task Information In Validation Management InterfacesAuto-on25R1.3

In 25R2, users who have a task to author, execute, review, or approve a test script or test protocol can now see a taskbar for completing their assigned tasks when using a Validation Management interface, such as the Test Authoring UI or the Test Execution UI. This helps users understand when their task is due and what instructions have been provided. This feature mimics the existing taskbar behavior present when a user with a task views a record in Vault. This feature is auto-on.

Periodic Review for EntitiesConfiguration25R1.3

In 25R2, users will be able to create and manage Periodic Reviews for entities. An entity will be able to be associated with multiple periodic reviews which have different scopes (for example, system review, access control review). Periodic Reviews can be ad hoc or recurring (based upon the type selected) and associated with multiple entities (for example, the production line system review). Periodic Reviews also include automation that will allow users to plan their Periodic Reviews but only have tasks initiated when the due date approaches and that will automatically create the next Periodic Review for recurring activities when a Periodic Review is completed. The feature is not visible to Validation Management users by default and requires configuration to use, including modifications to existing permission sets.

Reference Table Support for Requirements & SpecificationsConfiguration25R1.3

In the 25R2 release, Vault introduces the ability to add and manage reference tables directly within Requirement and Specification records. This enhancement enables users to structure and maintain tabular data associated with requirements, improving both clarity and efficiency. Users can create a reference table with up to 10 columns and 100 rows per requirement. Tables support rich editing functionality, including keyboard shortcuts for navigation and inline editing, similar to standard spreadsheet applications.

Users can generate a PDF from a Validation Entity Version with all requirements and reference tables. When users generate a PDF from a Validation Entity Version, if no requirements include a reference table, all requirements are consolidated into a single table. If at least one requirement contains a reference table, each requirement is exported in a separate table, with the reference table appearing immediately after the corresponding requirement. Users can also export an individual requirement record as a PDF, including its reference table if present.

Template Requirements can include a reference table to provide a predefined structure. The table does not need to be fully populated in the template. When a Validation Requirement is created from the template, the reference table structure is copied. Users can then modify the table as needed without breaking traceability to the original template.

The feature is not visible to Validation Management users by default and requires configuration changes to use the feature, including modifications to existing permission sets.

Regulatory

RIM Publishing

Render Published Documents on Rendition Bulk QueueAuto-on25R1.4

Document renditions that are part of Veeva published output will be processed by a different bulk internal renditions queue. Moving published renditions from its current queue to the bulk renditions queue will free up additional queue resources for published output, reducing potential backlogs on high priority items. The queue updates are backend changes only. Publishing end users and Admins will not experience any changes or disruptions in the publishing process.

Support Link Opening Preference in RLCP PublishingConfiguration25R1.3

A new selectable field, Published Links Opening Setting, on the Report Level Content Plan object will allow RLCP publishers to choose whether to open external document hyperlinks in a new window, or whether published hyperlinks will be opened per the user preference. While the link opening settings are determined for Submissions Publishing, the RLCP link opening settings were not region-specific, and did not reset when RLCP published output was included in a published submission.

Key Updates:

When configured, RLCP users will be able to select from the following picklist options on the Clinical Study Report (clinical_study_report__v), Nonclinical Study Report (nonclinical_study_report__v), and Report (report__v) Content Plan object types for the Published Links Opening Setting (pub_link_open_setting__v) field:

• Open in New Window (open_in_new_window__v)
• Window Set by User Preference (user_preference__v)

Any links resolved by the publishing process during RLCP publishing will respect the Published Links Opening Setting. If the field is not populated the system will set the opening preference on all links to Window Set by User Preference.

Automatic Deployment of Publishing Validation Rule RIM114Auto-on25R1.3

Publishing Validation Criteria rule RIM114 will be automatically deployed and executed with all Submissions Publishing jobs on Vaults licensed with Veeva Submissions Publishing. Previously a configurable feature, RIM114 will be executed on all published submissions.

Key Updates: For any Veeva Publishing environments where RIM114 was not previously added to a validation rule group, a ‘Submission Publishing System Validation Rules’ group will be automatically provisioned and populated with rule RIM114. If RIM114 is already added to a criteria group, ‘Submissions Publishing System Validation Rules’ will not be executed.

Support Language Attribute in HC eCTD DTD 2.2 SubmissionsAuto-on25R1.3

In accordance with Health Canada DTD updates, Veeva Publishing will now support generating language attributes for regional XML leafs, particularly for the Product Monograph section (Module 1.3.1).

Key Updates:

These changes support the HC requirement coming into effect on July 18, 2025. Upon publishing, an XML language attribute will be added based on the language code associated with the Language for Submission value set on a Content Plan Item.

Considerations:
As Health Canada began accepting voluntary submissions with the XML language attribute, these changes were previously included in the Maintenance Release associated with 25R1.0 and automatically pushed to all Production Vaults. Configuration to update Content Plan Templates is required, and can be provided to customers via VPK to aid in deployment.

Populate Merge Document Field on Root Content Plan for Submission Content PlansAuto-on25R1.3

The Merged Document field on the Content Plan object will be populated on the root Content Plan record with a link to the Submissions Archive document when the Merge and Publish Content Plan workflow is executed on Submission Content Plans.

Key Updates:

With this enhancement, the system now automatically populates the Merged Document (merged_document__v) field on the root Content Plan with the newly generated merged document. Users can now leverage configuration steps to automatically transition the merged document to its Steady State upon approval of the source documents. This involves configuring an Entry Action on the Content Plan Lifecycle’s Locked state.

This change ensures consistent behavior between Section Level Merge and full binder merges regarding the ability to set the merged document to Steady State.

Singapore eCTD 1.0Configuration25R1.2

Veeva Publishing now supports Singapore eCTD (ICH eCTD specification 3.2) publishing and validation, based on the Singapore Health Authority (HSA) regional specification package v1.0. Publishing customers can build eCTD Submission Content Plans including a new HSA Module 1 template, publish compliant submissions per XSD v1.0, and validate per the HSA Validation Criteria v1.0.

Singapore eCTD publishing will require configuration of the following, which can be provided to customers via VPK to aid in deployment:

• New Singapore v1.0 Module 1 Content Plan Template
• New Controlled Vocabularies and Constraints for HSA Application and Submission types/subtypes, Country/Health Authority, and DTD
• Validation Criteria v1.0 package
• Additional configuration for object Layouts

Health Canada REP Version 5.0.0Auto-on25R1.2

To support Health Canada REP submissions, CA eCTD and non-eCTD Validation rule I11 has been updated to validate the current software version, replacing the previous version 4.4.3.

Impacts:
The following XML types are in scope for software version 5.0.0:

• Human Use Drugs (Pharmaceutical)
• Veterinary Drugs
• Biologic and Radiopharmaceutical and Disinfectants

Considerations: As Health Canada began validation of REP XMLs with 5.0.0 beginning March 28, 2025, these changes were previously included in the Maintenance Release associated with 25R1.0 and automatically pushed to all Production Vaults.

Update US eCTD Valid Values XML Version 6Auto-on25R1.2

In accordance with updates to The Comprehensive Table of Contents Headings and Hierarchy, US eCTD submissions containing Study Tagging Files (STFs) in Module 4 or Module 5 will now be published with the ICH STF Valid Values v6.0 XML in the util folder.

Considerations: As FDA began accepting v6.0 February 18, 2025, these changes were previously included in the Maintenance Release associated with 25R1.0 and automatically pushed to all Production Vaults. Configuration to include the new STF Valid Values File Tags and update Content Plan Templates is required, and can be provided to customers via VPK to aid in deployment.

Update Acceptable File Formats for US eCTD Rule 1255Auto-on25R1.2

In accordance with updates to Specifications for File Format Types Using eCTD Specifications, the following file formats are now accepted under Module 5 for submissions to CDER:

• .gpsqlite
• .gpproject
• .gpsettings

Considerations: US FDA Validation rule Rule1255CDER has been updated accordingly to reflect the permissible file types. As FDA began accepting the new file formats February 18, 2025, these changes were previously included in the Maintenance Release associated with 25R1.0 and automatically pushed to all Production Vaults.

Prevent Multiple Submissions Sharing the Same Content PlanAuto-on25R1.2

A new system check will prevent publishing from initiating if the Content Plan field on the Submission record is used by another Submission record. If the primary submission on the Root Content Plan is found to be duplicated on another record, publishing will fail and be noted in the Error log.

Key Changes:

If the same Content Plan is used for multiple Submission records, publishing will fail and the user will be notified with the following Error log message:

“The Content Plan {Content Plan ID} is used in multiple Submissions {comma separated list of all Submissions}. Content Plans should only be associated with a single Submission, please update the Content Plan on the Submission record to ensure it is not used in other Submissions.”

Considerations:

This check will be automatically enabled and performed on all submissions to:

• Avoid data inconsistencies and conflicts caused by overlapping or duplicate content plans across submissions
• Prevent unintended changes to a content plan after a submission is published, ensuring that each submission maintains its integrity and independence

Support Additional Tokens for Table of Contents Referencing Section Merged DocumentsAuto-on25R1.2

When a Table of Contents (TOC) is included in a Section Level Merge published document, the TOC tokens will resolve based on merged document values captured at the Content Plan section level. Previously, tokens were resolved based on the Content Plan Item of the source files. With these updates, the section level TOC will more accurately reflect the contents of the section-level merged document.

Impacts: These changes will apply to both Submission Content Plan and Report Level Content Plan section merging.

Key Changes:

When a TOC targets a section merged document, TOC tokens will now resolve based on the following rules:

• edl_item_v.xlink_href__v: Uses the section_merge_published_output_location__v field from the merged section’s Content Plan
• edl_item_v.xml_title__v: Uses the title__v field from the merged section’s Content Plan
• All other tokens: Resolves using the first Content Plan Item (CPI) in the merged section, even if the CPI is a TOC or resolves to an empty value

Update PDF Validation Rule to Capture Opening View SettingsConfiguration25R1.2

A new criteria ID, RuleB43, has been introduced to validate PDF opening settings for compliance with Canada (Rule B43) and Australia (Rule 6.22) regulations.

Key Updates:

• Bookmarks Pane: Ensures documents with bookmarks open with the bookmarks pane displayed
• Magnification: Validates that the magnification setting is set to “Default”
• Page Layout: Confirms that the page layout setting is set to “Default”

To enable the above logic, the following configuration changes are required:

• Update the Vault RIM Validation Criteria ID to RuleB43 on the following UUIDs:
  • 236c6ccd-7f88-46a2-9a77-d60c161d2337
  • 1d6edc75-5600-4c30-9050-974a42445947
  • e13554a2-fa65-4f02-a1ad-623270165697
  • e3d6aa9b-7bc2-498a-ac08-960ec5160dc2

Impact: This update is recommended for all Publishing customers to ensure compliance with regulatory requirements in Canada and Australia.

Update RIM114 Validation ChecksAuto-on25R1.2

Publishing Validation Criteria Rule RIM114 has been updated to improve the identification and reporting of placeholder documents in the published output. This update introduces additional checks to determine why a document is published as a placeholder, along with detailed error messages to help users understand and resolve issues more effectively.

Full List of Rule RIM114 Checks

The updated RIM114 validation rule will report an Error if a placeholder is published in the following scenarios:

• Source for Published Document field is empty (NEW)
• Source for Published Document field contains a value that is not a valid Rendition Type (NEW)
• Matched Document(s) Ready For Publishing field does not equal “Yes”
• Published Output Location is empty and the operation is not “Delete”
• Matched Document Count is less than the Expected Steady State Count
• No Viewable Rendition exists when the Source for Published Document is set to “Viewable Rendition”
• No manual rendition exists when the Source for Published Document is set to a value other than “Viewable Rendition” or “Source Document”

If any of the above checks fail, the system will display a detailed error message explaining the reason for failure. If all checks pass but a placeholder document is still generated, a generic failure message will be displayed indicating that a placeholder exists.

This feature requires configuration updates in your Vault. If the RIM114 validation rule already exists in your Vault, the additional checks will be automatically applied without further action needed.

RIM Publishing, RIM Submissions Archive

System-managed Data Made Read-OnlyAuto-on25R1.2

Submission Metadata (submission_metadata__v) object records can no longer be created, updated (on standard fields, i.e., object fields ending in __v), or deleted from the Business Admin user interface (UI). The system prevents changes to standard object fields that are managed by the system, as these data fields are required for the proper display of imported or published submissions in Submissions Archive Viewer. If a Business Administrator attempts to update a standard field a pop-up message appears to explain the operation is not supported as described below. The purpose of this change is to protect customers from making changes that will result in significant downstream remediation efforts.

Key Changes:

• System Administrators: Vault Object Description will be updated to “System-managed object that is populated through the Submissions Archive import process and Publishing via Submissions Publishing.”
• Business Administrators: New error message “This operation is not supported. The data is read-only as it is system-managed.” will be displayed in the when attempting to create, edit, or delete a Submission Metadata record from the Business Admin UI.

Core eCTD 4.0 Publishing CapabilitiesConfiguration25R1.3

This release introduces key enhancements to Vault Submissions Publishing to support the ICH eCTD 4.0 standard, per ICH eCTD 4.0 Implementation Guide v1.6. Publishing of eCTD 4.0 submissions for Japan will leverage these capabilities beginning with the 25R2 release. Future regional support for eCTD 4.0 will also be based on these enhancements.

Key Updates:

Document Reuse: eCTD 4.0 introduces improved document and file reuse during on-demand publishing and continuous publishing. The system will automatically identify documents within eCTD 4.0 submissions that have previously been submitted within the same Lead Market, Health Authority, and Health Authority division. When such a document is matched to a Content Plan Item, the system will automatically process the document as a Reference Leaf by changing the Published Output Location to a relative path, and setting the Node Type to Reference Leaf. Additionally a new field has been added to the Content Plan Item Template and Content Plan Item object that allows users to disable automatic reuse across specific Content Plan Item.

Document Metadata Updates: Support for updating document metadata (Title) within on-demand and continuous publishing workflows allows for efficient management of document revisions. A new user action is available on the Content Plan Item, Set Document Update Operation. This action presents users with a dialog box to select a previously submitted document within the application and update that document’s Title. The system will set the eCTD 4 Modified Files field to the ID of the previously submitted document and the Node Type to Document Metadata Update.

Set Leaf Operation Enhancements: Enhancements to the Set Leaf Operation user action and interface enables users to Replace, Suspend (Delete), and Activate (New) documents previously submitted in both 3.2 and 4.0 formats, with appropriate handling of XML generation in the new submissionunit.xml. Additionally, for Replace operations, users are able to select multiple previously submitted documents in a one:many or many:one relationship. Upon save of Set Leaf Operation, the system will set the XML Operation based on the value selected in the Set Leaf dialog and set the eCTD 4 Modified Files field to the ID of the previously submitted document(s).

Delete/Suspend and New/Activate Lifecycle Operations:

Replace Multiple Previously Submitted Files:

New (Activate) previously Suspended files:

Keyword Management: The system supports handling of eCTD 4.0 Sender Defined Keywords, including introducing new Display Name fields on the Application and Submission referenced relationship objects. Additionally, new fields have been added to core objects eCTD 4 Code Name and eCTD 4 Display Name that can be used to default the code and display name on transactional objects in eCTD 4.0 Applications/Submissions. Refer to the RIM Data Model Updates for 25R1 and 25R2 for more details.

Priority Number Generation and Updates: Veeva Submissions Publishing now supports functionality to set and define Priority Numbers for Context of Use (CoU) within eCTD 4.0 submissions. These actions allow for control over the display order of Context of Use/documents within Submissions Archive. When a submission is published, the system will automatically set the Priority Number of each Context of Use to an increment of ‘32’. Within a Context Group, the Context of Use Priority Number will increase by 32 for each new CoU added to the group.

Additionally, a new user action, Update Priority Numbers, will allow users to change the display order of Context of Use (i.e., Content Plan Items) within a Context Group. A new Update Priority Numbers dialog allows users to update the priority number of a Content Plan Item, thereby changing the order of the documents displayed in Submissions Archive Viewer.

• Sort Alphabetically: Sort all Context of Use within the Context Group alphabetically by Title of filename of the document

• Move to Top: Move the current Context of Use to the top of the Context Group

• Move to Bottom: Move the current Context of Use to the bottom of the Context Group

• Move Below: Search for a specific Context of Use (by Title and sequence number) to move the current Context of Use below

Considerations: These enhancements collectively provide a robust platform for managing eCTD 4.0 submissions, ensuring compliance with current ICH eCTD 4.0 standards. These enhancements are general functionality that is non-region specific. eCTD 4.0 publishing support for additional regions will be added in subsequent releases, based on timelines provided by global health authorities.

Enablement of eCTD 4.0 publishing requires configuration, data model enrichment, Core Data updates, Content Plan Template updates, and business process modifications to prepare compliant submissions. Please reach out to your Veeva account team for eCTD 4.0 publishing enablement support, or to learn more about training opportunities for eCTD 4.0.

Japan eCTD 4.0 Publishing (JP v1.6)Configuration25R1.3

Veeva Publishing now supports Japan eCTD 4.0 publishing, based on the Pharmaceuticals and Medical Devices Agency (PMDA) regional specification package v1.6.0. This feature introduces the capability to generate compliant submissions and submissionunit.xml files, per the requirements from PMDA.

Key Updates:

Generation of submissionunit.xml for Japan: Vault can now create the submissionunit.xml, the core XML file for eCTD 4.0 submissions, in the format required by the PMDA.

Support for Japan Submission Methods: The system handles the three different submission methods defined by the PMDA, ensuring the correct XML output based on the selected method. Upon population of new metadata fields, including the Category Event field on the Submission object, the system will define the proper submission method. For example, the method and handling of information may change based on whether the submission includes study data or documents.

Update Submission Administrative Information: The subject2.review element of the submissionunit.xml, which contains product information, is generated and populated within the submission XML based on values provided in the Update Submission Administrative Information dialog. The existing user action, Update Submission Administrative Information, allows users to input and manage this data.

Document Reuse Logic: The system implements the specific rules for document reuse as defined by the ICH eCTD 4.0 specification and PMDA, including checks on application types and submission dates to determine if a document can be reused.

Considerations: ICH eCTD 4.0 publishing requires adoption of the eCTD 4.0 data model (released in 25R1 and 25R2) and data enrichment activities to support the ICH specification requirements. Content Plan Template updates to support PMDA specification v1.6.0 and ICH eCTD 4.0 are also required. Validation for Japan eCTD 4.0 will be included in an upcoming release. Core Data updates, particularly CVs and Constraints, are necessary to create the new submission types. Publishing Validation Criteria for Japan v1.6.0 submissions will be provided in an upcoming release. Please reach out to your Veeva account team for eCTD 4.0 publishing enablement support.

RIM Registrations

IDMP Data Model Updates (IG V2.2)images25R1.3

The IDMP Data Model and output generation algorithm have been updated to reflect the changes introduced in the EMA’s EU IDMP Implementation Guide, version 2.2, chapter 2. The EMA updates primarily affect the output structure, with minimal changes to existing entry objects and fields, notably the addition of the “Package PMS ID” field.

The changes implemented in Registrations to encompass this shift in the output structure include moving the manufacturing details from the Medicinal Product Element object to a new, separate Manufacturer Element which Vault then references by:

• Medicinal Product Element for a general overview of involved manufacturers.
• Manufactured Item Ingredient Element to link specific manufacturing responsibilities.

The IDMP Viewer automatically reflects these changes.

XEVMPD Validation EnhancementsAuto-on25R1.2

This feature updates XEVMPD data validation to align with the EMA’s latest (January 2025) XEVMPD 3.II guidance by incorporating a new acceptable Authorisation Status (AP.12.3): ‘Valid - pending national phase’. This status applies to medicinal products authorised by the Reference Member State (RMS) under Mutual Recognition (MRP) or Decentralised Procedure (DCP) while they are still under evaluation in the Concerned Member States (CMS).

Users who are responsible for submitting and managing XEVMPD data for marketed medicinal products will now be able to accurately reflect this Authorisation Status without receiving validation errors, ensuring their submissions comply with the latest EMA requirements. Updated validation rules automatically recognize this new term during data aggregation.

To enable this new status, Admins must add a new Controlled Vocabulary record in existing Vaults. Updates to the validation error behavior is auto-on in all environments upon release.

Create Related Records Validation Enhancements for Change ItemsAuto-on25R1.2

This release introduces enhancements to the Create Related Records functionality, specifically focusing on ensuring that packaging-level change items are accurately associated with the appropriate activities. Vault now implements more robust validation logic to determine when to create an Activity Change Item based on the products and packaging types relevant to each market.

Key Changes:

• Granular Control for Packaging-Level Change Items: The logic for creating Activity Change Items from Event Change Items is updated to consider the Packaging field on the Change Item. This ensures that changes related to specific packaging types are only applied to relevant activities.
• Activity Change Item Creation:
  • Adding or Replacing Packagings: When the Packaging field is populated on a Change Item and the Related Change Type is “Add,” “Replacing,” or blank, Vault creates an Activity Change Item only when when the packaging’s associated product variant (or complex product) is included in the registered products linked to the Activity.
  • Updating, Withdrawing, or Replacing Existing Packagings: When the Packaging field is populated and the Related Change Type is “Update,” “Withdraw,” or “Replacing,” an Vault creates an Activity Change Item only when the specific Packaging is listed in the registered packagings associated with the Activity.
• Comprehensive Validation Rules: Validation logic now considers the Product Family, Product, Product Variant, and/or Packaging fields on the Change Item.
• Active Record Validation: The validation process only considers active Registered relationship records.
• Consideration for User Modifications: Validation logic also takes into account active Application relationship records, as well as inactive Application relationship records that a user might choose to activate during the preview stage.

Impact: These enhancements improve the accuracy and relevance of automatically-created Activity Change Items, ensuring that changes are applied to the correct activities based on product and packaging market relevance. This leads to:

• Reduced manual intervention and rework.
• Improved data integrity and consistency.
• More efficient change management processes.

Create Related Records & Splitting Support for Labeling Concept ValidationConfiguration25R1.2

The Create Related Records and Splitting wizard validation are updated to ensure Labeling Concepts are only added to appropriate Activities based on the change items to which they are related.

When Vault creates Activity Labeling Concepts via Create Related Records, when a Labeling Concept is related to any Event Change Items, Vault only creates an Activity Labeling Concept for it if at least one of those Change Items passes the validation needed to be added to that Activity. When splitting Activities, Vault only shows Activity Labeling Concepts related to a selected Activity Change Item, and Activity Labeling Concepts whose Labeling Concepts are not related to any active Event Change Items.

Key Benefit: Activities will now include only the Labeling Concepts that truly pertain to the associated Event Change Items, reducing unnecessary record creation and making it easier to understand where there is a local labeling impact.

Considerations:

• This feature will not allow users to select specific Labeling Concepts to copy from Events to Activities using Create Related Records or Bundling. The expectation is that users will continue to select Change Items, and then the wizards will use the new many-to-many relationship to determine which Labeling Concepts to link to which Activities.

• If new Labeling Concepts are created for an event after Activities are created, those will be pushed by the existing triggers to all existing Activities, even if they might later be linked to a subset of Change Items that are not related to all Activities.

Impact Assessment Report Prompt Population from Change ItemsAuto-on25R1.2

This update streamlines the impact assessment process by automatically populating report prompts with relevant information from associated Event Change Item records.

Vault now automatically populates impact assessment report prompts based on the following:

• Product Prompts: Populated with the Products listed on any associated Event Change Item records.
• Product Variant Prompts: Populated with the Product Variants listed on any associated Event Change Item records.
• Packaging Prompts: Populated with the Packagings listed on any associated Event Change Item records.

Key Benefits:

• Improved Efficiency: Users no longer need to manually identify and add related Products, Product Variants, and Packagings to impact assessment report prompts.
• Increased Accuracy: Automatic population reduces the risk of overlooking relevant items, leading to more comprehensive impact assessments.
• Simplified Workflow: The process of creating impact assessment reports is now more intuitive and less time-consuming.

This enhancement ensures that all potentially impacted items are readily available for consideration during the impact assessment process.

Automated Counts of Total and Completed Events for Change ItemsAuto-on25R1.2

This release introduces new functionality to provide users with a clear understanding of the completion status of Change Items across all related Events (for example, market registrations). Veeva RIM now automatically tracks and displays the number of Total Events associated with a Change Item and the number of Completed Events.

Key Benefits:

• Automated Tracking: Veeva RIM automatically maintains counts of total and completed events linked to Change Items through the Event Change Item object.
• Completed Event Definition: Administrators can define which Event lifecycle states are considered to be complete via a new admin setting.
• Improved Visibility: Users can easily view how many related Events for a Change Item have reached completion. This information helps users understand the progress of a Change Item’s implementation across different markets or related processes.
• Streamlined Tracking: Automated updates eliminate the need for manual tracking of event completion status for Change Items.

This enhancement provides valuable insights into the overall progress and completion of Change Items, facilitating better management and coordination across related Events.

Configuration is required to enable this feature. Additionally, a new setting, Enable Counts of Total Events and Completed Events for Change Items, is added under the Use regulatory objective data as source when bulk creating registrations setting. The setting is disabled by default. When enabled, the Completed Event States control appears, allowing Vault Admins to select one or more lifecycle states from the Event object’s lifecycle to be considered as completed. Admins are required to select at least one completed state before saving the enabled setting.

RIM Submissions, RIM Registrations

GCP Dispatch Relationship Matching Logic Excludes Related Change TypeAuto-on25R1.3

Both Global Content Plan (GCP) Dispatch and Create Related Records (CRR) identify matching relationships between source events and target application, and submission records, however there are some differences in matching behavior. In this release, we are introducing an update to exclude Related Change Type from the matching logic for GCP dispatch.

Use Case: In this scenario, there is a Source Event with two Drug Product relationships, where we are replacing an existing Drug Product Manufacturer (Replaced by) with a new Drug Product Manufacturer (Replacing) (Related Change Type = Replace). However, in some markets, the submission will simply have one New Drug Product Manufacturer (Related Change Type = New) relationship.

Before: GCP dispatch would not match for any submissions with the New Drug Product Manufacturer, as it’s looking for a Replacing Drug Product Manufacturer. With the Copy Relationships setting disabled, the Content Plan (CP) section would be excluded for the New Drug Product Manufacturer. With the Copy Relationships setting enabled, a duplicate relationship would be created for the Replacing Drug Product Manufacturer and the CP section would be included.

After: GCP Dispatch matches for submissions with New or Replacing Drug Product Manufacturer relationships and will include the appropriate CP section in all Submission Content Plans.

Key Benefits:

• Improved Reliability: Ensures that GCP sections are dispatched correctly, preventing data loss.
• Enhanced Data Integrity: Prevents the creation of duplicate relationships, maintaining the integrity of your data.

Create & Manage Event Details: Support for Change Items & Labeling ConceptsAuto-on25R1.3

This release significantly enhances the Create and Manage Event Details functionality, providing users with greater control and efficiency in managing event-related changes, including labeling changes. You can now seamlessly integrate Change Items and Labeling Concepts into your Events, directly from the Create Event Details interface.

Key Enhancements:

• Change Item Management
  • Create new Change Items within the Create and Manage Event Details interface much faster than creating them one at-a-time directly from an Event.
  • Add existing Change Items, whether created in RIM or by the Quality-RIM Connection, to Events.
  • Use Change Items to populate product and packaging information for other Event details, streamlining data entry.
• Labeling Concept Integration
  • Create new Labeling Concepts directly within the Create and Manage Event Details interface.
  • Establish a many-to-many relationship between Event Change Items and Labeling Concepts, providing comprehensive tracking of how changes impact labeling.
• Admin Configuration
  • Exclude change item lifecycle states from Create Event Details setting: Admins can control which lifecycle states make existing Change Items available for selection.
  • Allow creation of change items in Create Event Details setting: Admins can enable or disable the creation of new Change Items within the Create Event Details interface.
  • Add change item and labeling concept details to Event Change Types: Admins can configure which types of changes should prompt the user for Change Items and or Labeling Concepts in Create and Manage Event Details.
  • Admins should review the new RIM Object Configuration for Change Items, which is used to determine the order of fields displayed when creating those records in Create Event Details.
• Flexible Record Creation
  • With the introduction of Optional Preview in this release, users can now choose to generate a preview of records or create them immediately from Create Event Details.

Benefits

• Improved Efficiency: Manage Change Items and Labeling Concepts directly within Create Event Details, resulting in fewer clicks and less time spent updating your Event.
• Enhanced Data Accuracy: Ensure consistency and accuracy by linking Change Items to Labeling Concepts and using Change Items to populate Event details.
• Greater Control: Admins gain granular control over Change Item availability and creation through new settings.
• Streamlined Workflows: Simplify event management processes with the ability to create records directly or preview them first.

This enhancement empowers users to manage events with greater precision and efficiency, ensuring that all related changes and labeling considerations are accurately tracked and managed.

Create Event Details: Optional PreviewAuto-on25R1.3

With this release, Optional Preview is being introduced to Create Event Details. Similar to Optional Preview for Create Related Records introduced in 25R1, users can now choose to generate a preview of records or create them immediately from Create Event Details, offering greater flexibility and control over the record creation process.

Defaulting Local Differences in Product Variants onto Application RelationshipsAuto-on25R1.3

This release introduces enhancements to the Create Related Records and Bundling functionalities in Veeva RIM. These enhancements focus on improving the handling of local differences in product variants when creating new application relationships. Specifically, the system will now automatically default local differences for attributes like Active Substance Name and Strength based on preferred terms and any country-specific exceptions defined for those product variants.

Key Changes

• For Active Substance and Inactive Ingredients, when creating new Application relationship records, the system will populate the local name and strength fields by referencing the preferred term or value from the Product Variant record. It will also consider any country-specific exceptions. If neither a preferred term/value nor an exception exists, the fields will be left blank. This ensures that local variations are accurately reflected in the new application records.
• For Products, the Local Manufactured Dosage Form field on the Application Product Characteristics record will be populated based on the preferred controlled vocabulary term from the Product Manufactured Dosage Form record, taking into account any country-specific exceptions. If no preferred term or exception is found, the field will be left blank.
• For Physical Characteristics, the system will populate the Physical Characteristics field with the preferred value from the Product Variant Physical Characteristics record. However, if there’s a country-specific exception defined for the Application’s lead market, that exception will be used instead. If neither a preferred value nor an exception exists, the Physical Characteristics field will be left blank.

These updates streamline the process of creating related records and bundling by automating the population of local data, reducing manual entry and improving consistency. This feature is dependent on data model changes from the “IDMP Support for Local Differences in Product Variant Attributes” feature introduced in 25R1, and will be automatically enabled.

Population of XML ICH DTD / XSD Version on Submissions Created by Bundling & SplittingAuto-on25R1.3

When the XML ICH DTD / XSD Version field is populated on an application, any new submissions created for that application by the bundling or splitting processes will have the same field populated from the application’s field value. This ensures data consistency when new submissions are created through bundling or splitting.

EUDAMED UDI Market Information Updates: UDI Submission GenerationConfiguration25R1.3

This release enables you to comply with updates to market information for devices already registered in EUDAMED.

Key Highlights

• A new dedicated UDI submission type ensures compliance with BR-DTX-UDI-105, allowing you to accurately reflect market changes for UDI-DIs and EUDAMED IDs that have already been registered.
• When generating UDI submissions for marketing information updates, the system automatically identifies and incorporates relevant market information, including new countries and changes to start/stop dates based on related registrations. This automation minimizes manual effort and ensures data accuracy.
• Market Information submission data can be reviewed in the UDI Submission Viewer, and the XML that is generated can be uploaded to EUDAMED.
• A new Registered DI Country object provides a centralized view of market-specific information for each registered UDI-DI and EUDAMED ID, including placement dates and lifecycle states.

With this release, you can fully comply with the complexities of EUDAMED’s Market Information requirements. A subsequent release will enable market information submissions to be submitted directly to EUDAMED from RIM.

UDI Submission Support for Multiple Products with the Same Basic UDIAuto-on25R1.3

This new Veeva Registrations feature removes the need for each Product to have a unique Basic UDI, providing more flexibility in how you define your products in RIM and enabling you to include information for multiple products sharing the same Basic UDI within a single UDI submission.

Important Feature Enablement and Considerations

To leverage this enhanced functionality, consider the following:

1. The Enable enhanced UDI attribute locations setting must be enabled.
2. The naming pattern for the Device Identifier object must be updated to allow for multiple records with the same Basic UDIs.
3. The Registration Scope for Marketed Device Registrations for the European Union must be set to Marketed Product Group, and all products sharing the same Basic UDI must be included within the same European Union registration and related country registrations.
4. User Access Management is crucial. Ensure that users granted access to generate a UDI submission for one product have the necessary access to all other products sharing the same Basic UDI and their associated packagings with UDI-DIs. Failure to do so may result in incomplete data registration.
5. Registrations exceeding 300 Basic UDI-DIs may encounter inconsistencies if products with the same Basic UDI-DI are split across multiple UDI submissions.

This enhancement empowers you to manage your product data with more flexibility while still complying with EUDAMED UDI regulations.

RMS Sync EnhancementAuto-on25R1.3

Veeva RIM’s Integration with the EMA’s SPOR RMS database has been enhanced to offer more granular control over term synchronization. Previously, synchronizing terms in the Human and Veterinary use domain required selecting both Human use and Veterinary use. Now, a dedicated Human and Veterinary use option is available, allowing for the selection of more specific terms. This improvement will allow customers to include only the relevant domains. For example, a company with human medicinal products can now efficiently include Human use and Human and Veterinary use and exclude Veterinary use if desired.

To manage these Filter Terms, follow these steps:

1. Navigate to Admin > Operations > Job Definitions.
2. Open the RMS Integration and Synchronization job and click Edit.
3. Review the available Domain values and select or deselect terms you want to include or exclude from updates.

Important: Before modifying your connection, ensure that the selected terms are correctly mapped to existing Controlled Vocabulary terms in your Vault.

Dynamic Validation EnhancementsAuto-on25R1.3

This release introduces updates to the Create Related Records validation process introduced in 24R3, enhancing data integrity when establishing relationships between Events and Applications, Regulatory Objectives, and Submissions. These updates improve and introduce validation rules to effectively manage data generation, specifically for matching rules under the “Add” Event Change Action.

The following updates are included:

• New rules now validate the addition of details from container__v and device__v Event Shelf Life or Condition records, aligning with existing functionality for packaged_product__v object type records.
• For Substance Applications, a new rule now validates the addition of details from Event Active Substance records against Application Active Substances, excluding the check in the case of new Applications.
• Rules for validating relationships between Nonclinical/Clinical Studies and a Product Family now use the Product Family Nonclinical Study and Product Family Clinical Study relationship objects instead of the Primary Product Family field on the Study object.
• When adding Inactive Ingredient Details, Product validation now has a fallback. If the Event Inactive Ingredient’s Product field is empty, Vault looks up the Product Variants related to that Inactive Ingredient in the master data and pulls their associated Products to perform the validation.
• When adding Active Substance Details, Product validation is skipped now to Substance Applications.
• Validation for adding Site Details to a Site Application is now skipped if the Application is new.
• Rules for adding Authorization Details now prioritize Product Variant when available in the Event relationship. Otherwise, they use Product.

Users benefit from these enhancements through improved error reduction and increased reliability when creating related records.

RIM Submissions

Warning File for GCP Dispatch and Submission Compare & MergeAuto-on25R1.2

A new warning file is added to the Dispatch Global Content Plan and Submission Compare & Merge user actions to log source Content Plan sections that are intentionally excluded when “Copy Relationships” is disabled. No changes to the exclusion behavior have been made, however, a downloadable CSV warning file has been introduced to better communicate expected system behavior to end users.

Key Benefits:

The more detailed warning messages both alert the end users that an exception has occurred, and enable customers to troubleshoot and correct GCP dispatch errors without requiring outside support.

Key Changes:

The following examples outline the more detailed warning messages for common configuration settings that result in one more more CP/CPI records to fail to copy during GCP Dispatch, Synchronization, or Compare & Merge actions:

	Previous Information	New Information
Supporting relationship missing in target AND Copy Relationships is not enabled	Dispatch Status = Complete	Dispatch Status = Complete - With Errors Warning Message: Not included because {Event relationship object label}: {Event relationship name} does not exist on {target Submission name}
Target Submission relationship set to Use for Content Planning = No	Dispatch Status = Complete	Dispatch Status = Complete - With Errors Warning Message: Not included because {Submission relationship object label}: {target Submission relationship name} has Use for Content Planning field label = No

Considerations: Warnings are listed in hierarchical order. If an entire CP section (including child CPs & CPIs) is not dispatched, the warning will display only for the top-most CP record for the section. This included failure to copy at the Root CP level.

Deprecate “FTP” term from Submissions ArchiveAuto-on25R1.2

To better align with standard Veeva terminology, all references to “FTP” in the Submissions Archive user interface and notifications will be changed to “File Staging Server,” “File Staging,” or “FSS.” While there are no changes to Submissions Archive functionality or connectivity to any staged files, users may notice the slight wording changes throughout their use of the system. For example:

Before: To import from this dialog, the submission package must be under 4GB. Use Vault FTP to import larger submissions.

After: To import from this dialog, the submission package must be under 4GB. Use the Vault File Staging server to import larger submissions.

Disable Grouped Submission IndicatorAuto-on25R1.3

The Grouped Submissions icon () that currently, and erroneously, appears on all submissions with a valid us-regional.xml has been removed from the Submission Archive Viewer grid. This feature removes the icon from use. Accurate display of the icon for true grouped submissions will be addressed in an upcoming release.

US eCTD Grouped Submission imports are not affected by this change.

Taiwan (TW) eCTD 2.0 (ICH eCTD v3.2)Auto-on25R1.3

With this release, Submissions Archive supports importing, viewing, and exporting of Taiwanese submissions using the TW FDA’s Specification eCTD-V-R2, for eCTD submissions.

Core eCTD 4.0 Submissions Archive capabilitiesAuto-on25R1.3

This release introduces key enhancements to the Submissions Archive to support the ICH eCTD 4.0 standard, per ICH eCTD 4.0 Implementation Guide v1.6. Import of eCTD 4.0 submissions for Japan will leverage these capabilities beginning with the 25R2 release. Future regional support for eCTD 4.0 will also be based on these enhancements.

Key Updates:

Submission Import: Submissions Archive supports import of eCTD 4.0 submissions across all import modalities, inclusive of:

• User Interface (“Upload now,” choose file from local machine)
• Vault File Manager
• Vault API
• File Staging (root folder and user folder, if configured)

When an ICH eCTD 4.0-based submission is imported to Submissions Archive, the system creates Application eCTD Keyword records for each Keyword Definition that exists in the submissionunit.xml.

Submission Removal: When an ICH eCTD 4.0-based submission is removed from the Submission Archive, the system also deletes the Application eCTD Keyword records associated with that Submission.

Viewing: When a single ICH eCTD 4.0-based submission is applied in the Submission filter, Submissions Archive Viewer displays the Submission Unit (submissionunit.xml) and SHA-256 checksum (sha256.txt) file in the Name column. When more than one submission is applied in the Submission filter, Submissions Archive Viewer hides the Submission Unit and SHA-256 files.

Display of eCTD Keywords: Submissions Archive Viewer displays eCTD 4.0 Sender Defined and Health Authority Defined Keywords. The system shows the Keyword Display Name and a key indicator () to the right of the Keyword in the grid cell.

Hovering over the key indicator displays the Keyword hovercard which details the Display Name, Submission, Sequence ID, and Actual Submission Date information. For example, a Sender Defined Key appears as shown:

With this initial release:

• Sender Defined Keywords will appear with Display Name in the grid cell and on the Keyword Hovercard

• Health Authority Defined Keywords will appear with the Keyword Code value in the grid cell and in the Display Name on the Keyword Hovercard.

Health Authority Defined Keywords will appear with the Code value. The user-friendly Label will not appear for these in the initial release.

Searching for eCTD Keywords: The XML columns in the Submissions Archive Viewer are text-based filter columns. With 25R1, users can search for Keywords by the Code value in the text-based filter columns. The user-friendly Label will not yield results when used to search in the text-based column.

eCTD Metadata Updates (eCTD 4.0): Submissions Archive Viewer exports a CSV file on demand, providing a list of metadata updates (namely, Priority Number and Document Title updates,) that are not visible on the Viewer grid due to applied Submission filter(s).

eCTD Metadata Update Export: A new user action, eCTD Metadata Update, appears in the All Actions menu on the Submissions Archive Viewer grid when at least one ICH eCTD 4.0-based submission has been imported to a Submission in the Application. This action appears automatically and no configuration changes are required to make it appear in Submissions Archive Viewer.

The system will send a notification via the Notification bell and email to the initiating user when the CSV file is available for download. If there are no new updates to report, or if the applied Viewer grid filters have all the updates exposed, the eCTD Metadata Update export will yield no results.

eCTD Metadata Updates - CSV column	Description
Type of Update	Identifies the row as a Priority Number or Document Title update
UUID	The unique identifier value. If the Type of Update = Priority Number, this is the Context of Use UUID that is the target of the Priority Number update. If the Type of Update = Document Title, this is the Target Document’s UUID for the Document Title update
Orphaned Update?	When this is False, this means the system is able to fully resolve the Metadata Update in the Submissions Archive Viewer in Application View (i.e., when no Submission filters are applied in the Submission column filter) When this is True, the system cannot resolve the Metadata Update because the Context of Use or Document for the Priority Number or Document Title update, respectively, cannot be found in the system. This can occur when submissions are imported out of sequential order, or when a prior submission is not imported to the system
Value (Before Update)	This displays the value of an Update Target before its update via the eCTD 4.0 Metadata Update (either Priority Number Document Title update) This column operates in tandem with the Sequence ID containing the Update Target column. See below for a representative example of the two columns.
Sequence ID containing the Update Target	This is the Sequence ID where the Update Target (Context of Use or Document) was submitted To see the full contents update, see the example table below.
Value (After Update)	This displays the value of an Update Target after its update via the eCTD 4.0 Metadata Update (either Priority Number of Document Title update) This column operates in tandem with the Sequence ID (where the update was made) column. See below for a representative example of the two columns.
Sequence ID (where the update was made)	This is the Sequence ID where the Update Target (Context of Use or Document) was submitted To see the full contents update, see the example table below.
Sequence ID applied in Viewer	This shows the Sequence ID values of the Submission records that are applied to the Submission column E.g. “7, 9” - meaning Submission with Sequence ID: 7 and Submission with Sequence ID: 9
Link to Viewer with Submission filters that produced this output	This provides a URL that opens to Submissions Archive Viewer with the Submission filters applied to the specific Submission records that produced the eCTD Metadata Updates CSV file
Link to Viewer with Submission filters to visualize all updates	This provides a URL that opens to the Submissions Archive Viewer with the Submission filters needed to visualize all updates.

Considerations: Vault does not produce an automatically filtered or sorted CSV output file.

Example of full eCTD Metadata Updates, showing values before & after:

Viewing eCTD Lifecycle HistoriesAuto-on25R1.3

In this release, Submissions Archive Viewer has a re-designed and improved user interface for reviewing eCTD Lifecycle Histories of both eCTD 3.2 and eCTD 4.0 submissions. The new user interface is automatically compatible with all content that has been previously imported or published with Veeva Publishing, and all submissions imported or published after the release.

Key Updates:

Historical Lifecycle Viewing:

The user interface enhancements apply to the Historical Lifecycle of Document (user action available from Documents in eCTD submissions) and Cumulative View (user action available on eCTD Sections).

Historical Lifecycle of Document (eCTD 3.2 submission):

Historical Lifecycle of Document (eCTD 4.0 submission):

• The Lifecycle History displays as a horizontal timeline with columns representing each sequence
• The Sequence ID column header appearance and order (from left-to-right) is determined by the value entered on the Submission record
• When a single submission is applied to the Submission column filter and the Historical Lifecycle of Document is opened, a Checkmark icon () appears in the Sequence ID column header to indicate the Current filtered sequence. This icon does not appear in Historical Lifecycle of Document when more than one submission is applied in the Submission filter, nor does it appear in Cumulative View for a section.
• The Name column behavior is updated to display orange highlight cell-shading, making it easier to identify where an action was initiated. The orange highlight cell-shading persists as long as the action persists:
  • A document is clicked to open its Viewable Rendition in the embedded Document Viewer
  • The Historical Lifecycle of Document action is launched for a document
  • The Cumulative View action is launched from a section containing documents

Document Cards:

Document Cards appear in the Sequence ID columns. Document cards with the View in Mini-Browser () and Submission Details () icon represent active documents in the eCTD Lifecycle, whereas Documents only showing the Leaf icon are Deleted (ICH eCTD 3.2) or Suspended (ICH eCTD 4.0).

• In the Historical Lifecycle of Document, the Document Card that the view was launched from will appear in with special styling (blue shading)
  • Lines emanate from the left and or right of the Document Cards to connect it to the XML Operation. In the event that the Lifecycle appears to be broken or unexpected, check the Import Notification email to reviewing any Import Warnings and or the Content Plan (if using Veeva Publishing).
  • When a Document is removed from the Lifecycle via a Delete operation (ICH eCTD 3.2) or Suspend operation (ICH eCTD 4.0), a Deleted or Suspended Document Card, respectively, appears in the user interface with special styling (light gray with dotted edge). An ICH eCTD 4.0 lifecycle example follows, where the removed Document is shown in Sequence ID column 5:

Operator Icons:

• Operator Icons display between Sequence ID columns, and are connected via lines emanating from Document Cards
• The Operator icons appear as follows given the ICH eCTD Version (3.2 or 4.0):

Cumulative View for Sections:

• Cumulative View displays the documents in a section in Submissions Archive Viewer as a Document Header
• Document Headers are sorted Ascending by Sequence ID
• When Cumulative View is launched, the first Document Header automatically expands. The Document Header is collapsable.
• Vault allows one Document Header to be expanded at a time. Expanding a collapsed Document Header will auto-collapse the open Document Header.

Japan (JP) v1.4, v1.5, v1.6 (eCTD 4.0)Auto-on25R1.3

With this release, Submissions Archive supports importing, viewing, and exporting of Japan submissions that were published according to the PMDA eCTD 4.0 Module 1 Implementation Guide, versions 1.4, 1.5, and 1.6.

Considerations:
Japan v1.4, v1.5, and v1.6 submissions should be imported in sequential order (e.g. Sequence ID 1 is imported prior to Sequence ID 2, and Sequence ID 2 is imported prior to Sequence ID 3). If submissions are imported out of sequential order, the submission structure may not display as expected.

RIM Submissions, RIM Submissions Archive

Active Dossier: Configurable Template SupportAuto-on25R1.3

This release introduces the ability to configure Active Dossier Template (ADT) records and support for multiple Active Dossier hierarchies. This allows more flexibility for customers with diverse needs, and allows Active Dossier to be used beyond just the pharmaceutical Common Technical Dossier (CTD) structure. We are also introducing a new standard Investigational CTD AD Template and supporting RIM Reference Models. These enhancements provide the following capabilities:

Customization of Standard Active Dossier Templates

Users can now customize Standard Active Dossier Templates to align with organizational terminology and specific business requirements. This includes the ability to:

• Modify Displayed Section Name fields.
• Reorder ADT records within a single level in the hierarchy.
• Incorporate new records to track additional customer-specific documents.

Updates made to templates are automatically synced to the Active Dossier records.

Limitations: Note that updating display names of sections with tokens and creating custom ADT records with tokens is not supported.

Updates to existing Active Dossier Templates:

• The RIM Reference Model field on Active Dossier Templates will be non-editable for standard templates. Because this field was previously editable, existing standard templates in customer environments will be updated to refresh the RIM Reference Model field value if there are discrepancies from the standard.
• A new system-managed Root Template field has been added to the Active Dossier Template. It is automatically set on existing Active Dossier Templates.

Creation of Custom Active Dossier Templates

The system now supports the creation of new template hierarchies to accommodate diverse product types or business needs (e.g., for Animal Health tracking), with a limit of up to 500 nodes per hierarchy. Creation of custom Active Dossier Templates within a standard template hierarchy is also supported

Utilization of Multiple Active Dossier Templates

• A new Active Dossier Template field has been added to Application to designate the relevant template for populating and viewing Active Dossier for that Application.
• The Active Dossier Viewer will now support selection of the hierarchy when there are multiple. The selector will not be displayed when there is a single or no Active Dossier hierarchy in the Vault.

These updates provide administrators with greater flexibility and control over Active Dossier Templates, enabling them to tailor the system to specific organizational requirements and diverse product types.

Enablement

• The functionality to update and create ADT records is auto-on.
• To fully leverage the new Active Dossier Templates and manage multiple Active Dossier Hierarchies, additional configuration will be required.

Active Dossier: Dates & Comments TrackingAuto-on25R1.3

Active Dossier users can now track relevant status dates and comments on new fields on the Active Dossier Item Detail (ADID) record. The new fields are filterable and sortable in the AD Viewer and Editor to better visualize and organize the information for consumers.

Key Updates:

New fields will be automatically active and available for use following the release:

• Dispatch Date: This date will automatically be recorded when an Active Dossier Item Detail (ADID) is initially created from a GCP dispatch. You may inactivate this field if your organization does not use Global Content Plans.
• Submitted Date: This lookup field will show the Actual Submission Date value of the related Submission record.
• Approval Date: This date will be automatically populated or updated with the Regulatory Objective record’s Actual Decision Date when an ADID moved to a “Pending Current” status, or if an existing (Pending Current, Current) ADID is found during Regulatory Objective calculation.
• End Date: This date will be automatically set with the superseding Regulatory Objective’s Actual Decision Date when an ADID is calculated as Pending Superseded or Pending Deprecated. It will also be automatically set if an ADID is moved to Rejected, or Withdrawn from a Regulatory Objective state change.
• Comments: Free-text field that allows for users to add notes or additional context about the record.

Additional changes have also been made to improve usability of the Active Dossier Viewer, including:

• Support for applying multiple global filters: You can now apply multiple select global filters, such as a Product Family with a Manufacturer. A new Date filter is available that can be applied with any filter object.
• Updated Sorting in Item Detail Layout: Within each section of the Active Dossier Viewer and Editor, items will now be primarily sorted by Application Name (alphabetically) and then secondarily by Active Dossier Status (alphabetically)

• Updated Sorting in Country Overview Layout: In the Active Dossier Viewer’s Country Overview, items will now be primarily sorted by Source Document Name (alphabetically) and then secondarily by Document Version (newest to oldest).

• Documents displayed with mime-type icons to align with other areas within Vault that display documents. This makes it easier to identify documents’ file types at a glance.

• Permission enforcement within the Active Dossier Viewer has been updated to enforce users’ permissions to the filter object & respective fields on the Active Dossier objects in order to apply the global filters.

Benefits:

• Visibility of key dates allows for easier tracking of the sequence of records within Active Dossier
• Improved efficiency and ease of use with new filtering and sorting capabilities in Viewer
• Allowing for additional communication through comments
• Easy access to information with improved Hovercard details and Country Overview contents
• Ability to export new fields in Excel format

Active Dossier: Latest for Authoring TrackingAuto-on25R1.3

Active Dossier users can now easily identify the latest version of source documents, by Application, to be used by authors to make content updates. These changes improve the Active Dossier population process, as well as use of the Viewer and Editor interfaces, and replace the manual and error-prone process of comparing documents to identify which should be upversioned.

Key Updates:

Two new filterable fields available in the Active Dossier Viewer grid allow AD users to filter out any source documents that are not the latest internally approved version, or find when a previous version was superseded.

• Latest for Authoring (latest_for_authoring__v): Filterable Yes/No field that tracks if the displayed document is the latest internally approved document that should be used by authors
• Latest for Authoring End Date (latest_for_authoring_end_date__v): Filterable Date field that captures when this document version is no longer the latest for authoring

Calculations to populate the fields will occur upon creation or update of ADID records.

Impact:

Latest for Authoring and Latest for Authoring End Date fields will update upon creation of new Active Dossier Item Details from a Submission, dispatch from a Global Content Plan (GCP), Drag & Drop into the Active Dossier Editor, and from newly created records through Active Dossier Loader.

The new fields are supported in both the AD Loader and AD Excel tree export.

Benefits:

The additional filtering for the latest document version to update functionality of AD, particularly for large global customers with many active products, can help customers quickly identify the correct version of documents to use as the starting point for an authoring update or used to populate a submission in a new market. In particular, users managing multiple Events with parallel variations or changes will benefit from knowing that the latest document version is being updated, and the date when a document became no longer current. This will also reduce the time spent traversing the AD Viewer looking for documents requiring update.

Active Dossier Performance & Scalability ImprovementsAuto-on25R1.3

With this release, Active Dossier processes have been updated to move from a single consumer queue to the multi-threaded Vault jobs queue framework. This will allow processing in parallel to support better scalability of Active Dossier. While these changes are mostly on the back end, there are a few changes that users may notice:

• Active Dossier jobs are now surfaced in the Vault Jobs Admin pages.
• The Document Version ID, Document Major Version, and Document Minor Version fields will no longer be synced if the document’s version changes. These fields will continue to be set upon initial creation of the Active Dossier Item.
• Inactivation of the Active Dossier Template will no longer be cascaded to Active Dossier records.

Finally, query optimizations have also been introduced to improve the Active Dossier Viewer performance.

Support Approval Type Field in Active Dossier LoaderAuto-on25R1.3

This release introduces the ability to load values into the Approval Type field via the Active Dossier Loader.

Previously released in 24R3, the Approval Type field in the Active Dossier Item Detail object supports status tracking (Explicit, Implicit, or Partial Approval). Customers can now load values in this field via the Active Dossier Loader, streamlining Active Dossier baseline migrations.

Learn more about using the Active Dossier Loader.

Disable Archive Path in Active Dossier PopulationConfiguration25R1.3

When populating Active Dossier from a Submission, the system can be configured to no longer create Active Dossier records based on the source documents found in the Submission Archive (linked via the Source Reference). This update streamlines the Active Dossier population process by making the Content Plan the single source of truth when populating from a Submission.

Key Updates:

A new optional setting on the Populate the Active Dossier action will direct the system to only search the Content Plan documents and metadata to create records, and will disregard Submissions Archive when populating the Active Dossier.

The “Archive” related fields on Active Dossier Item Details will now be directly populated based on the corresponding information from the Content Plan, instead of a mix of information from the Archive document’s Source Relationship and Submission record relationships. This means that the Submissions Archive Document field on ADIDs will only be set for submissions published in Vault when this setting is on.

Benefits:

• Active Dossier will only reflect the documents matched in the Submission Content Plan, instead of both Content Plan & Archive.
• Unexpected records can be more easily addressed by examining the Content Plan, and without the need to investigate Submissions Archive relationships as well.
• For customers who publish non-eCTD submissions, this update may prevent the potential creation of seemingly duplicate records. Previously, records could be generated both from the Content Plan and the Archive, leading to cleanup efforts. Now, only the Content Plan will drive the creation.

RIM Registrations, RIM Submissions, RIM Submissions Archive

Active Dossier Population from GCP Dispatch: Support Dispatch Across TemplatesAuto-on25R1.3

For customers who have enabled the Populate Active Dossier checkbox on their GCP dispatch, Active Dossier records will now also be automatically generated if they are using cross-template dispatches (a functionality released in 24R2).

The previous 24R2 release introduced the ability to dispatch GCPs to submissions with different Content Plan Templates (CPTs) via mappings. This supported GCP use across Investigational Applications (CTAs, INDs) and MedTech Applications, as well as different Module 1 structures for CTDs.

With this release, Active Dossier records are now generated not only when dispatching both the structure and documents to a submission with the same Content Plan Template (CPT), but also in cross-template dispatch scenarios (documents-only dispatch). This ensures that when dispatching a GCP to Submissions with a different CPT, the corresponding Active Dossier records are generated when the necessary conditions are met. Please note that Active Dossier records are created even for documents that are unmapped or later rejected in the comparison.

RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive

Health Authority Interaction Extraction UpdatesAuto-on25R1.3

With this release, up to 500 words can now be extracted with the Health Authority Interaction extraction feature. Additionally, several minor UI updates have been made to the Health Authority Interactions document panel:

• The delete icon is now only surfaced upon hovering over a card instead of always displaying
• When extraction of only either HAQ or Commitment is enabled but not both objects, the object dropdown is disabled

RIM Bot: Multilingual ModelSupport25R1.3

This feature expands the RIM Bot’s coverage by supporting the training and automatic classification of documents that are in non-English languages. More than 30 languages are supported. This feature must be enabled by Support in 25R2, and will be made auto-on in a future release.

Safety

Beginning with 25R1.3 and for all subsequent releases, Safety releases on the same date as the Veeva Vault Platform. For the latest central dictionary updates for your Safety Vault, see Safety Central Dictionary Updates.

Several features listed in the Vault Connections section also affect the Safety application family.

Safety

Automated Acknowledgement of Email to InboxAuto-on25R1.2

With this release, Veeva Safety automatically sends an acknowledgement email to inform senders that their email has been successfully received by Vault and an Inbox Item created. This feature introduces a picklist for the Inbound Email type of Transmission Profile, allowing Admins to specify which senders receive the acknowledgement.

Learn More

• Enablement: Enable Automated Acknowledgement of Email to Inbox
• Admin Help:
  • Configure Email to Safety Inbox Item
  • Manage Transmission Profiles
• User Help: Email to Inbox Item

Formula Expressions for Online Questionnaire Follow-up RulesConfiguration25R1.2

With this release, Veeva Safety supports formula expressions for the follow-up questionnaire rule engine to evaluate Case data for a rule. Previously, Follow-up Rule Criteria did not allow usage of complex rule expressions to support more sophisticated business use cases.

Learn More

• Enablement: Enable Online Questionnair​​es for Follow-Ups
• Admin Help: Set Up Follow-Up Online Questionnaires
• User Help: Send a Follow-Up Online Questionnaire to Case Contacts

QC Checklists: Post Closure Checklist LogAuto-on25R1.2

With this release, Veeva Safety generates a CSV log file and adds it as an attachment to the applicable Post-Closure Checklist Creation Rule following the specified Post-Closure QC Interval setting in Vaults with QC Checklist Generation enabled.

Learn More

• Admin Help: Configure QC Checklist Creation Rules

Expectedness Reevaluation for Postmarket Follow-Ups

This feature is deferred to a future release.

With this release, Veeva Safety supports reevaluating expectedness based on follow-up information for postmarket Cases. When enabled, Vault reevaluates expectedness whenever new information is merged to an in-flight Case or promoted to a follow-up Case.

Generate Case Collections by Case VersionConfiguration25R1.2

In the 24R1 release, Veeva Safety introduced Case Collections to enhance the ability to review and report on groups of Cases. This feature enabled the export of multiple E2B and CIOMS I forms for the latest Case version at once. With this release, Case Collections can be created for specific Case versions in addition to the latest version. This provides greater flexibility in managing Case data, enabling more precise reporting and analysis.

Learn More

• Enablement: Enable Create and Export Case and Safety Report Collections
• User Help: Manage Case and Safety Report Collections

MedDRA Support for Additional LanguagesAuto-on25R1.2

With this release, Veeva Safety supports browsing, searching, and coding of MedDRA terms in the following nine (9) languages: Croatian, Estonian, Finnish, Greek, Icelandic, Latvian, Lithuanian, Polish, and Swedish. This feature improves global accessibility and efficiency by supporting MedDRA term browsing, and searching in additional languages.

Learn More

• Admin Help: Manage the MedDRA Dictionary

Early Notification ReportsConfiguration25R1.2

Veeva Safety now supports the ability to use the reporting rules engine to automate transmission of early notification (24/48/72 hour) reports to agencies and partners. This feature introduces the Early Notification Report rule parameter and the Evaluate Early Notification Obligations action. When the Evaluate Early Notification Obligations action runs, the Safety rule engine evaluates rules with an Early Notification Report rule parameter and generates the necessary Transmissions.

Learn More

• User Help:
  • Early Notifications, Submissions, and Distributions Overview
  • Create an Early Notification Report
  • Reporting Rule Parameter Reference

DSUR and PBRER: Active Comparator BreakdownAuto-on25R1.2

The DSUR and PBRER aggregate reports now provide a breakdown of Case counts for each Active Comparator combination, displayed in the new Active Comparator Breakdown tab within the DSUR and PBRER cumulative tabulations. Previously, all Active Comparators were grouped under a single column. This enhancement improves the clarity and granularity of Case data reporting, allowing for more precise analysis of each Active Comparator combination.

Learn More

• Admin Help: Configure Aggregate Report Templates
• User Help:
  • Create DSUR Aggregate Reports
  • Create PBRER Aggregate Reports

DSUR: Ability to Include Fatal Adverse Events in Cause of Death ColumnAdmin Checkbox25R1.2

With this release, the DSUR List of Subjects Who Died tabulation has the option to include additional sources of information for the cause of death. When this option is enabled, the Preferred Terms (PTs) of all Adverse Events indicated as fatal on the Case are also included in the Cause of Death column.

Learn More

• Admin Help: Safety Application Settings & Configuration Options
• User Help: Create DSUR Aggregate Reports

Individual Case Routing CriteriaConfiguration25R1.2

With this release, Veeva Safety allows Admins to configure rules that flag Cases for specialized review, such as Signal or medical review. When a Case meets the conditions, Veeva Safety applies routing tags and can trigger actions. This feature replaces custom SDK logic with a flexible, scalable, and maintainable solution.

Learn More

• Enablement: Enable Individual Case Routing Criteria
• Admin Help: Configure Individual Case Routing Criteria

Assessment Dechallenge: Data ModelAuto-on25R1.2

With this release, Veeva Safety introduces the Dechallenge and Dechallenge (Override) fields to the Case Assessment object. Starting with this release, users can manually enter dechallenge values in the Dechallenge (Override) field for internal reference only. Auto-population of the Dechallenge field will be included in a future release.

This feature was released in 25R1.2 without documentation.

Standard Health Canada Mappings for Safety Inbox Item ProcessorAuto-on25R1.3

With this release, Veeva Safety supports standardized field mappings for Health Canada, enabling seamless use with the Safety Inbox Processor for multi-Case tabular data import. Previously, Admins had to manually configure the Tabular Data Format, Import Field Mappings, and Import Code Mappings for this health authority.

This update simplifies setup, reduces configuration time, minimizes user error, and ensures consistency across submissions to Health Canada.

Learn More

• Admin Help: Manage Multi-Case Tabular Data Import

Document Intake Highlighter: Product ExtractionSupport25R1.3

With this release, Veeva Safety improves the Document Intake Highlighter panel to improve efficiency during the document intake process. Admins can now configure automatic identification and extraction of company products from unstructured and semi-structured documents into the panel. Intake users retain control by having the option to review and reject extracted terms before adding products to the Inbox Item. Previously, users had to manually highlight products within documents for extraction. This update reduces manual effort, increases accuracy, and gives Admins and users greater control over the intake workflow.

Learn More

• Enablement: Enable Document Intake Highlighter
• User Help: Document Intake Highlighter

Document Intake Highlighter: User Interface UpdatesAdmin Checkbox25R1.3

With this release, Veeva Safety introduces several improvements to the Document Intake Highlighter panel, including:

• Pagination Enhancements: Users can highlight up to 500 products and 500 events in the panel, which was previously limited to ten (10). The panel paginates items for improved navigation.
• Advanced Filtering: The summary view allows users to filter annotations by product items, enabling faster access to relevant data.
• Enhanced Hovercards: Users can view product and event details in hovercards in both view and edit mode.
• Additional Product Classifications: Users can now classify products within the panel as Similar Device and Unknown for future classification.
• Drag and Drop Categorization: Users can now recategorize products by dragging them to specific navigation tiles to move them to different sections, allowing for easier organization.
• Flexible Deletion Options: Users can delete unsaved items immediately or mark existing items for future deletion upon Case promotion.

These updates streamline user workflows, making managing and reviewing product data quicker and more intuitive.

Learn More

• Enablement: Enable Document Intake Highlighter
• User Help: Document Intake Highlighter

Duplicate Search Potential Matches Page SettingAuto-on25R1.3

With this release, Veeva Safety introduces a new setting, Duplicate Search Potential Matches App Page.

Increase Generic Name Field Length to 500 CharactersAuto-on25R1.3

With this release, the Generic Name field on the Product Family object increases from 100 to 500 characters to support the Safety-RIM Connection.

Rules Based Narratives: UpdatesConfiguration25R1.3

With this release, the Rules Based Narrative Generation feature has several updates that further streamline and improve efficiency during case processing, including:

• Bulk Unblind: During bulk unblind follow-up creation, if a user enters text on the Narrative Text field Vault generates a Case Follow-up Statement with the contents of the field value.
• Copy Narrative Outline: New action that copies a Narrative Outline and its associated Narrative Statements.
• New Functions: New functions to use when configuring Statement Formulas for Narrative Statement Options:
  • Dose Frequency: Allows Admins to specify the formatting of dosage frequencies, such as "2 times per day" instead of "every 0.5 days".
  • Prefix Date Range: Allows Admins to format how dates export as well as specify if the first letter should be uppercase or lowercase, such as "From "{start date}" to "{end date}".
• Case Follow-Up Statements: Vault copies Case Follow-Up Statements to new Case versions from previous versions.

Learn More

• Enablement: Enable Rules Based Narrative Generation
• Admin Help: Configure Rules Based Narratives
• User Help: Generate a Case Narrative

Expectedness Reevaluation for Postmarket Follow-UpsAdmin Checkbox25R1.3

With this release, Veeva Safety supports reevaluating expectedness based on follow-up information for postmarket Cases. When enabled, Vault reevaluates expectedness whenever new information is merged to an in-flight Case or promoted to a follow-up Case.

Learn More

• Enablement: Enable Expectedness Reevaluation for Postmarket Follow-Ups
• User Help: Enter Case Data

Exclude External Products During Assessment GenerationAdmin Checkbox25R1.3

With this release, Admins can choose to exclude External Products from consideration during automatic Case Assessment generation. Previously, Vault created Case Assessments for all product and event combinations, including External Products. By reducing unnecessary Case Assessments, Case Processors can focus on only the relevant information needed for Case submission, streamlining data entry, improving efficiency, and reducing workload.

Learn More

• Enablement: Enable Generate Assessments Record Action
• User Help: Generate Assessments

Case Assessment Expectedness Datasheet Type IdentificationConfiguration25R1.3

With this release, to clearly indicate the type of Datasheet used to evaluate expectedness, Veeva Safety introduces the Datasheet Type field on Case Assessment Expectedness records. Previously, those records identified only the specific Datasheet. This removes the need for users to review related records to determine the Datasheet type.

Learn More

• Enablement: Enable Case Assessment Expectedness Datasheet Type Identification
• User Help: How Case Assessment Expectedness is Generated

Simplified Case Product Registration DeletionAuto-on25R1.3

With this release, Veeva Safety supports deleting Case Product Registrations with a single click. Deletions cascade to associated localized records and clear references in related records. These updates also apply when deleting Case Products that are referenced on Case Product Registrations on Localized Cases when merging or promoting follow-up items through the Inbox Item to Case Compare page. Previously, users had to manually delete multiple records across various objects, which was time-consuming and error-prone. This enhancement saves time, reduces manual effort, and minimizes the risk of data inconsistencies during Case processing.

Learn More

• User Help: Complete Intake and Process Cases for the PMDA

MedDRA Dual-Language Coding for Case ProcessingAuto-on25R1.3

With this release, Veeva Safety updates the user interface on domestic Cases to make coding easier for medical terms reported in supported non-English languages. The update applies to Case Adverse Events, Case Drug Histories, Case Test Results, Case Causes of Death, Case Product Indications, and Case Diagnoses. Reported and coded terms now display in both the selected local language and English.

Learn More

• User Help: Code MedDRA Terms

MedDRA Chinese, Japanese, & Korean Language Search ImprovementsAuto-on25R1.3

With this release, Veeva Safety improves search results when searching for medical terms against the Chinese, Japanese, and Korean MedDRA dictionaries. Previously, MedDRA did not support partial search matches for Chinese, Japanese, or Korean terms.

WHODrug Link KoreaSupport25R1.3

With this release, Veeva Safety automatically codes External Product information for domestic and foreign localized Korean Cases based on the coded WHODrug term, eliminating the need to manually enter localized MPID values. This improves efficiency, accuracy, consistency, and regulatory compliance.

Learn More

• Enablement: Enable WHODrug Link Korea
• Admin Help: Manage WHODrug Link Korea
• User Help: Code WHODrug Products

Centralized Medical Assessment ViewConfiguration25R1.3

To streamline medical review, Veeva Safety introduces a central view of all related assessment details. The configurable Medical Assessment section on Case layouts enables viewing and evaluating all Case Assessments, Case Assessment Results, and Case Assessment Expectedness records from a single place. Previously, completing a medical review required users to navigate across three (3) different sections within a Case. This enhancement significantly improves efficiency and reduces review time by consolidating critical information into a single, easily accessible view.

Learn More

• Enablement: Enable Centralized Medical Assessment View
• User Help: Perform Medical Assessments

LATAM VigiFlow E2B GenerationAuto-on25R1.3

With this release, Veeva Safety supports the generation and submission of individual case safety reports in the LATAM E2B(R3) format for submissions to Latin America. This feature includes all of the regional data elements required by Latin American countries to facilitate transmissions to the VigiFlow Industry eReporting adverse event management system.

Learn More

• Admin Help: Standard Agency ICSR Submissions
• User Help: E2B Generation: LATAM E2B(R3) Mapping

Case Validation for FDA E2B(R3)Auto-on25R1.3

With this release Veeva Safety supports the validation of the FDA E2B(R3) file type. These validations help customers ensure that the information on their forms is compliant with the agency’s business rules before submitting the file to the FDA.

Learn More

• User Help Case and Submission Validation

Safety Data Expression Building BlocksConfiguration25R1.3

With this release, Veeva Safety introduces Safety Data Expression Building Blocks. Admins can create one or more Safety Data Expression Building Block records, each containing a Case data evaluation expression. Admins can then reference (and optionally combine) these Safety Data Expression Building Blocks in any number of Safety Rules by using the new Safety Data Expression Building Blocks reporting rule parameter. This provides a more efficient way to create Safety Rules, and reduces the effort required to manage large groups of Safety Rules.

Learn More

• Admin: Create Safety Data Expression Building Blocks
• User Help Reporting Rule Parameter Reference

Submit to Gateway for Custom E2B IntegrationsConfiguration25R1.3

With this release, Veeva Safety improves the auto-Submit to Gateway action to accommodate custom E2B Transmission document integrations. Previously, Vault generated and sent the first version of the E2B Transmission document to the gateway. Customers with custom E2B Transmission document integrations had to configure their Transmission Lifecycle to generate the document using an entry action, then send the Transmission. With this enhancement, customers can now use the auto-Submit to Gateway action in conjunction with their custom E2B Transmission document integrations.

AS2 Connection: Sponsor Certificate GenerationAuto-on25R1.3

With this release, Veeva Safety introduces the ability for Admins to create a Sponsor certificate within Vault for use with an AS2 Connection. Previously, these certificates had to be created outside of Vault. Alternatively, Admins can continue to upload a Sponsor Certificate for an AS2 Connection that was created outside of Vault. After creating or uploading a Sponsor Certificate, Admins can download the Public Sponsor Certificate for sharing with the Partner associated with the connection.

Learn More

• Admin: Manage AS2 Connection Certificates

AS2 Connection: Deprecate API Name Support for CompressionAuto-on25R1.3

With this release, Vault no longer uses the API Name of an AS2 Connection to determine whether to send the data for the connection compressed or uncompressed. Instead, Vault now uses the AS2 Compression Settings of an AS2 Connection alone to determine the compression behaviour for the connection. Previously, Vault sent messages uncompressed if the API Name of the connection started with ucr_, regardless of the connection’s AS2 Compression Settings.

Learn More

• Admin:
  • Configure FDA AS2 Connection
  • Configure EMA AS2 Connection
  • Configure Health Canada AS2 Connection
  • Configure MHRA AS2 Connection
  • Configure PMDA AS2 Connection
  • Configure NMPA AS2 Connection
  • Configure RZN AS2 Connection
  • Configure MFDS AS2 Connection
  • Configure TGA AS2 Connection
  • Configure Custom AS2 Connections

AS2 Connection: Deprecate API Name Support for ACK on MDN SettingAuto-on25R1.3

With this release, Vault no longer uses the API Name of an AS2 Connection to determine whether the connection accepted the ACK on MDN URL. Instead, Vault now uses the AS2 Partner Sends ACK on MDN URL setting of an AS2 Connection alone to determine this behavior for the connection. Previously, Vault allowed the ACK on the MDN URL if the API Name of the connection started with ucr_russia_gateway, even if AS2 Partner Sends ACK on MDN URL was set to No.

Learn More

• Admin:
  • Configure FDA AS2 Connection
  • Configure EMA AS2 Connection
  • Configure Health Canada AS2 Connection
  • Configure MHRA AS2 Connection
  • Configure PMDA AS2 Connection
  • Configure NMPA AS2 Connection
  • Configure RZN AS2 Connection
  • Configure MFDS AS2 Connection
  • Configure TGA AS2 Connection
  • Configure Custom AS2 Connections

Safety Workbench

Document Sensitivity ClassificationAuto-on25R1.2

With this release, users can set a Document Sensitivity value on Workbench Reports and Workbench Report Definitions. The classification is inherited by generated reports and automatically applied to documents uploaded to the Vault Library.

Learn More

• User Help:
  • Manage Workbench Reports
  • Manage Workbench Report Sets

Totals and Sorting for Grouped Data on Workbench ReportsAuto-on25R1.2

With this release, Veeva Safety Workbench enhances ad-hoc grouping by allowing users to sort data that has been grouped in the Workbench Report layout. Users can organize report results by any grouped field, such as Country or Seriousness, in order to improve readability and consistency. In addition, users can choose to display summary totals across all groups in the report output. This feature reduces reliance on custom Workbench Views and simplifies the creation of summary tabulations.

Learn More

• User Help:
  • Set Up the Workbench Report Layout
  • Use Custom Templates for Workbench Reports

Generate Case Collections from a Workbench Case SeriesConfiguration25R1.2

With this release, Veeva Safety Workbench allows users to generate a Case Collection from a Workbench Case Series for use in Veeva Safety. This enables bulk generation and sharing of CIOMS I unmasked and masked reports as well as E2B(R3) reports. Case Collections support up to 1,000 Case versions and streamline data exchange with external partners.

Learn More

• Enablement: Enable Generating Case Collections from Workbench Case Series
• User Help: Generate Case Collections from Workbench Case Series

Generate Reports from Workbench Report DefinitionsConfiguration25R1.2

With this release, Veeva Safety Workbench allows users to generate new reports directly from a Workbench Report Definition, without requiring a Workbench Report Set. Generating reports from Workbench Report Definitions allows Admins to implement standards for report generation and users to reuse layouts, templates, and advanced options for better consistency. This feature supports user adoption of reporting standards and improves efficiency through reusable, discoverable report templates.

Learn More

• Enablement: Enable Generating Reports from Workbench Report Definitions
• User Help: Generate & Run Reports from Workbench Report Definitions

Filter Workbench Reports and Dashboards by MedDRA QueriesConfiguration25R1.2

With this release, Veeva Safety Workbench introduces the ability to filter Workbench Reports and Workbench Dashboards by any term defined within a standard or custom MedDRA Query using the Event (LLT) field of Case Adverse Events.

This feature simplifies filter configuration, as terms within a MedDRA Query are not restricted to lowest level terms (LLTs). Custom MedDRA Queries can also be maintained and reused, allowing users to create reports more efficiently.

This feature was released in 25R1.2 without documentation.

Workbench Report Set SchedulingConfiguration25R1.3

With this release, Veeva Safety Workbench introduces the ability to automatically generate Workbench Report Sets on a schedule, ensuring timely compliance and reducing the manual workload required to generate recurring reports.

When creating a Workbench Report Set, users can select a predefined schedule, enabling Vault to:

• Run the Workbench Report Set and generate Workbench Reports on the specified schedule
• Upload the resulting to Workbench Report Excel files to the Library
• Notify Workbench Report Set viewers of new report documents

Multi-Level Sorting for Workbench Reports and DashboardsAuto-on25R1.3

With this release, Veeva Safety Workbench introduces multi-level report sorting. Users can now sort by multiple field columns for ad-hoc reports and dashboards. This feature enhances flexibility and user control over report data organization, reducing the need for SQL to provide complex sorting requirements.

Learn More

• User Help:
  • Set Up the Workbench Report Layout
  • Sort Data on Workbench Dashboards

Use Workbench Report Parameters in SQLConfiguration25R1.3

With this release, Veeva Safety Workbench allows users to enter report parameters that can be referenced directly in the associated Workbench View’s SQL when the Workbench Report runs. With user-written SQL, this feature expands the range of Workbench Views that can be created by users.

Learn More

• Admin Help: Configure Safety Views in Safety Workbench
• User Help:
  • Use Custom Templates for Workbench Reports
  • Use Workbench Report Filters
  • Manage Workbench Report Sets

Ability to Specify Products and Studies in Aggregate Reporting GroupsAuto-on25R1.3

With this release, you can specify Products and Studies in Aggregate Reporting Groups. This streamlines the reporting process when generating Workbench aggregate reports that are based on Products or Studies, such as DSURs. This feature improves consistency and efficiency in regulatory submissions by simplifying the selection criteria for report datasets.

Learn More

• Admin Help: Configure Aggregate Reporting Groups

Workbench DSUR Aggregate ReportsAuto-on25R1.3

With this release, Veeva Safety Workbench introduces the ability to generate Development Safety Update Report (DSUR) components, including:

• Interval Line Listing of Serious Adverse Reactions from Clinical Trials
• Cumulative Tabulations of Serious Adverse Events
• Serious Adverse Reactions from Clinical Trials
• List of Subjects Who Died

As well as the following additional components:

• Case Series Report
• Open Cases Report

Admins can configure these reports in masked and unmasked formats to satisfy specific reporting requirements.

Although this feature is Auto-on, some components require additional configuration.

Workbench PBRER Aggregate ReportsAuto-on25R1.3

With this release, Veeva Safety Workbench introduces the ability to generate Periodic Benefit-Risk Evaluation Report (PBRER) components, including:

• Interval Line Listing of Serious Adverse Reactions from Clinical Trials
• Cumulative Tabulation of Serious Adverse Events from Clinical Trials
• Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources

As well as the following additional components:

• Case Series Report
• Open Cases Report

Admins can configure these reports in masked and unmasked formats to satisfy specific reporting requirements.

Although this feature is Auto-on, some components require additional configuration.

Safety Signal

EBGM Calculations Updated with Case CountsAuto-on25R1.2

With this release, Veeva Safety Signal updates standard views used in Empirical Bayes Geometric Mean (EBGM) calculations to use unique Case counts instead of product-event pair counts. This approach improves accuracy by reducing the impact of duplicate reports and regulatory decision-making since agencies, such as the FDA, often consider unique Case counts in EBGM calculations.

Learn More

• User Help:
  • Signal Detection Calculations
  • Signal Detection Using PV Data

FAERS Data for Signal Detection 25R1.3

With this release, Veeva Safety Signal supports the FDA Adverse Event Reporting System (FAERS) as a data source for signal detection. Veeva will clean, code, and de-duplicate FAERS data to standardize product and event terms, enabling its use in disproportionality analysis.

Learn More

• User Help: Signal Data Sources

FAERS Case Reconciliation ReportAuto-on25R1.3

With this release, Veeva Safety Signal introduces a Workbench Report that runs using FAERS data and generates Case listings to support reconciliation between FAERS and Veeva Safety. The report identifies FAERS cases that are not found in Safety, which are then reviewed for potential signal analysis. This feature supports case completeness and alignment with health authority reporting data.

Learn More

• User Help: FAERS & VAERS Reconciliation

VAERS Data for Signal Detection 25R1.3

With this release, Veeva Safety Signal supports the Vaccine Adverse Event Reporting System (VAERS) as a data source for signal detection. Veeva will code and de-duplicate VAERS data to standardize event terms, enabling its use in disproportionality analysis.

Learn More

• User Help: Signal Data Sources

VAERS Case Reconciliation ReportAuto-on25R1.3

With this release, Veeva Safety Signal introduces a Workbench Report that runs using VAERS data and generates Case listings to support reconciliation between VAERS and Veeva Safety. The report identifies VAERS cases that are not found in Safety, which are then reviewed for potential signal analysis. This feature supports case completeness and alignment with health authority vaccine safety data.

Learn More

• User Help: FAERS & VAERS Reconciliation

Individual Case Review for Signal AnalysisConfiguration25R1.3

With this release, Veeva Safety Signal introduces individual Case reviews (ICRs) for signal detection. Signal ICRs are automatically created based on routing rules and linked to specific Case Products. Signal reviewers can assess individual Cases without affecting ongoing Case processing and determine whether a Safety Investigation is needed.

Learn More

• Enablement: Enable Performing Signal Individual Case Reviews
• User Help: Perform Signal Individual Case Reviews

Signal Case Series Generation with Scheduled CalculationsConfiguration25R1.3

With this release, scheduled Signal Calculations can now automatically generate Signal Case Series. A Case series represents the underlying Case data and maintains a static list of Case versions for signal analysis. This feature ensures consistency between manual and scheduled signal calculations.

Learn More

• Admin Help: Configure Scheduled Signal Calculations & Alerts
• User Help: Scheduled Signal Calculations & Alerts

SafetyDocs

Prevent Duplicate Local Implementation Strategy RecordsAuto-on25R1.2

With this release, Veeva SafetyDocs prevents the creation of duplicate Local Implementation Strategy records for Countries that already have an existing Local Implementation Strategy, eliminating the potential for duplicate records.

Learn More

• User Help: Manage Implementation Strategies

Literature Article QC SamplingConfiguration25R1.2

With this release, Veeva SafetyDocs introduces the ability to conduct randomized quality control (QC) sampling of literature articles. When configured, SafetyDocs uses a specified sampling percentage to route Literature Articles with selected verdicts through a review workflow, helping to ensure data quality.

Learn More

• Enablement: Enable Literature Review Process Management
• User Help: Manage the Literature Review Process

Literature Inclusion in Aggregate ReportsConfiguration25R1.2

With this release, Veeva SafetyDocs supports an additional verdict on Literature Articles and Literature Article Products, allowing users to evaluate articles for inclusion in aggregate reports. This feature introduces:

• Two new aggregate report-related fields on Literature Articles and Literature Article Products
• A new standard report type that filters for Literature Articles and Literature Article Products marked for inclusion, with prompt filtering on Product Family and Access Date

Learn More

• Admin Help: Enable Literature Inclusion in Aggregate Reports
• User Help: Manage the Literature Review Process

Multiple Product Families on Safety InvestigationsConfiguration25R1.2

With this release, users can now include multiple Products and Product Families in a Safety Investigation using a new object, Safety Investigation Product. Previously, users could add only a single, primary Product Family to a Safety Investigation. This feature provides greater flexibility and a more comprehensive approach to investigating safety issues across multiple Products and Product Families, such as allowing users to include Products and Product Families that are concomitant or interacting with the Safety Investigation’s primary Product.

Learn More

• Enablement: Enable Multiple Product Families on Safety Investigations
• User Help:
  • Signal Management
  • Create Safety Investigations

Automated Distribution of PVA ReportsConfiguration25R1.3

With this release, Veeva SafetyDocs supports automatic distribution of scheduled PVA Vault Report or Workbench Report Set documents. This eliminates the need for manual dispatch, streamlining partner communication when circulating recurring reports.

Learn More

• Enablement: Enable PVA Scheduling
• User Help:
  • Distribute PVA Documents via Email
  • Distribute PVA Documents via Vault Task
  • Manage Pharmacovigilance Agreements

Multi-Recipient PVA Document DistributionConfiguration25R1.3

With this release, Veeva SafetyDocs extends the PVA document distribution functionality by introducing the ability to distribute PVA Activity documents to multiple users, rather than just one. This enhancement better accommodates PVA distributions that require backup support from a partner organization. The feature is available for both email and Vault task-based distribution of PVA activities.

Learn More

• Enablement: Enable Multi-Recipient PVA Document Distribution
• User Help:
  • Distribute PVA Documents via Email
  • Distribute PVA Documents via Vault Task
  • Manage Pharmacovigilance Agreements

Risk Implementation Strategy EnhancementsAuto-on25R1.3

With this release, Veeva SafetyDocs enhances risk implementation strategy management, allowing for greater specificity by:

• Updating the Copy to New Version and Create Local Implementations actions to prevent the creation of new Core Implementation Strategy document versions to give users more flexibility in their updates
• Extending the Create Local Implementations action to create local-only Local Risk Measures for regions without a previous Global Risk Measure

Learn More

• User Help: Manage Implementation Strategies

Document State Automation for PVAConfiguration25R1.3

With this release, Veeva SafetyDocs introduces two new actions to the PV Agreement object, allowing Vault to update certain documents to your Vault’s steady state or superseded state to match the state of their linked PV Agreement. This allows your PVA documents to automatically transition states in accordance with their related PV Agreement’s state, reducing the manual effort required to maintain your PVA documentation in Vault.

Learn More

• Enablement: Enable Document State Automation for PVA
• User Help: Manage Pharmacovigilance Agreements

Safety & Safety Workbench

Latest Case Version in Period for Ad-Hoc Reporting & AnalyticsAdmin Checkbox25R1.2

With this release, Veeva Safety introduces an updated approach to determining when a Case version is superseded. Vault now marks Cases as superseded only when the Case reaches a terminal state, rather than upon the creation of a follow-up Case. In addition, to enhance visibility into Case version history and support reporting and analytics, Vault introduces a new application setting. When enabled, Vault maps more date information to superseded Cases through the following new Case object fields:

• Next Case Version
• Next Case Version New Info Date
• Next Case Version Approval Date

Learn More

• Enablement: Enable Latest Case Version in Period for Ad-Hoc Reporting & Analytics

Safety Workbench & SafetyDocs

Distribute Workbench Reports ExternallyConfiguration25R1.3

With this release, Veeva SafetyDocs extends its PVA scheduling and document distribution functionalities to Workbench by adding the ability to:

• Automatically generate Workbench Reports and their documents from Workbench Report Sets on a defined schedule
• Distribute these documents to external partners via Vault task as PVA Activities or via email

This enhancement enables scalable partner distribution by reducing the manual effort required to distribute documents to partners for review.

Learn More

• Enablement: Enable Distribute Workbench Reports Externally
• User Help: Manage Pharmacovigilance Agreements

QualityOne

QualityOne

Tree & Child Object Security on Standard Objects 25R1.2

The Tree Security and Child Object Security Platform features are applicable only for certain Veeva Vault applications and do not apply to QualityOne standard objects.

New Application: QualityOne HACCPAuto-on25R1.3

With this release, we’ve moved existing HACCP features into a new application, QualityOne HACCP. QualityOne HACCP allows organizations to establish and maintain safe food production practices across manufacturing sites and regions. Moving HACCP features into the new QualityOne HACCP application provides customers with greater flexibility of their QualityOne solution.

Learn more about QualityOne HACCP.

QMS (QualityOne)

5 Whys Analysis: Improved Error HandlingAuto-on25R1.2

This feature improves the error handling when performing 5 Whys Analysis. Now, if users encounter permission issues while interacting with certain elements like the Why object, they’ll receive clearer and more informative messages with guidance on how to resolve the situation.

Learn more about performing 5 Whys Analysis.

CoA: Ingest Text-Based Variations of Comparison SymbolsAuto-on25R1.2

This feature improves the ingestion of CoA files that contain language-based variations of comparison operator symbols, such as “larger than” and “less than”. With this release, Admins can create Comparison Variant records to help Vault extract these variations from CoA files and set the value of the corresponding symbol on Inspection Sample Test Result records, increasing the accuracy and efficiency of CoA file processing at scale.

Learn more about configuring Comparison Variants.

5 Whys Analysis: UX & Security EnhancementsAuto-on25R1.3

With this release, the 5 Whys Analysis user interface now provides a more accurate reflection of individual user permissions, particularly when key permissions are missing. For instance, if a user lacks Delete permission for Why records, the corresponding delete icons will now be disabled.

Learn more about performing 5 Whys Analysis.

CoA: Supplier Site Address Ingestion ImprovementConfiguration25R1.3

This feature enhances the Organization data model to let users enter more granular address data, and increases the likelihood of successful ingestion of address information from CoA files. When the Analyze COA action runs, Vault scans the CoA file for the closest matching address using data from the new Address object and configured Organization Matching Variants and, upon finding a match, updates the Inspection record with the supplier site address. If Vault cannot find a matching address, the address on the Inspection record is not updated, maintaining the integrity of your existing data. This feature allows for greater precision and control in ingesting Organization address data, increasing straight-through processing of CoA files and reducing manual data entry.

Learn more about managing Organization Matching Variants.

HACCP

HACCP Flow Diagram: Minimap NavigationAuto-on25R1.2

With this release, a minimap displays on the HACCP Flow Diagram’s canvas to enable users to quickly navigate large HACCP Plans. The minimap displays the structure of the HACCP Flow Diagram with the user’s area of focus highlighted. Users can click and drag the minimap to navigate to different areas in the diagram. This feature offers improved navigation and context awareness, allowing users to instantly locate and navigate to different sections of the diagram without having to scroll or zoom in and out repeatedly, saving time and effort.

Learn more about working with the HACCP Flow Diagram.

HACCP Flow Diagram: Resizable Information PanelAuto-on25R1.2

Previously, the Information panel was constrained to a fixed size. With this release, users can click and drag the edges of the Information panel to resize it to a larger or smaller width that suits their screen size. This feature allows users to review more data at once, improving the efficiency and ease of performing hazard analysis.

Learn more about working with the HACCP Flow Diagram.

HACCP Plan Translation: File Size LimitAuto-on25R1.2

When users export and import a translation file for a HACCP Plan, Vault now limits the JSON file size to 250 MB.

Learn more about translating HACCP Plans.

Manage HARPC within the Flow DiagramConfiguration25R1.3

With this release, the HACCP Flow Diagram now supports Hazard Analysis and Risk-Based Preventive Controls (HARPC) processes for a broader, more proactive hazard analysis approach. HARPC functionality allows organizations to evaluate all potential hazards and implement preventive controls to mitigate risks throughout the food production process. This improves compliance with global regulations and safety standards, such as the Food Safety Modernization Act (FSMA) and similar EU regulations, without requiring separate systems.

Learn more about creating HARPC plans and performing hazard analysis.

Process Step Search within the HACCP Flow Diagram CanvasAuto-on25R1.3

This feature introduces a search bar on the HACCP Flow Diagram’s canvas that lets users search for a process step by display name. This allows users to access and manage relevant details without manually scrolling through the entire diagram.

Learn more about working with the HACCP Flow Diagram.

HACCP Flow Diagram: Configurable Information PanelConfiguration25R1.3

With this release, Admins can configure the Information panel to display only the sections and fields relevant to the user’s workflow, enhancing efficiency. This feature lets Admins disable the Hazard Assessment and Categorization of Control Measures sections, as well as add and remove fields within the Hazard Assessment and Potential Hazard Description sections, with the expectation that these processes are managed outside the diagram.

Learn more about configuring and working with the HACCP Flow Diagram.

HACCP Flow Diagram: Hazard Analyses Section FilteringAuto-on25R1.3

This feature works in conjunction with the previously released Pagination in the Hazard Analyses Section feature to provide the ability to filter the displayed list of records in the Hazard Analysis section to match one (1) or more Hazard Classification values and a given hazard analysis completeness status.

Learn more about the Information panel.

HACCP Flow Diagram: Subsequent Steps EnhancementAuto-on25R1.3

With this release, when users add or remove subsequent steps during hazard analysis, Vault automatically refreshes the record list and hazard analysis completeness status and reason of Process Hazard Analysis and PHA - Subsequent Step records in the Hazard Analyses section of the Information panel. This ensures users are viewing up-to-date information without needing to refresh the panel. Additionally, this feature introduces a limit of 50 to the subsequent steps that users can add or remove at once.

Learn more about adding subsequent steps.

Add Materials to HACCP PlanConfiguration25R1.3

Previously, users were limited to associating a single Material record with a HACCP Plan to represent a finished or semi-finished product. With this release, users can add multiple materials to a HACCP Plan by creating HACCP Plan - Material records from the new HACCP Plan Materials section on HACCP Plans. Additionally, Admins can configure the HACCP Plan Materials section to display translated material field data. With this feature, organizations can reuse the same HACCP Plan across multiple similar products, improving the overall efficiency of their HACCP program.

Learn more about configuring the HACCP Plan Materials section and adding Materials to HACCP Plans.

QMS (QualityOne) & Document Control (QualityOne)

External Collaboration Management: Enhanced License AssignmentAuto-on25R1.3

With this release, external users created via the Create and Activate External Collaborator action are now exclusively assigned a QMS or Document Control license. This ensures a seamless external collaboration process and prevents license conflicts with other Vault applications.

Learn more about working with external collaborators on QMS objects and document review and approval.

QMS (QualityOne) & HSE

Generate Document From Formatted Output Action: Word Formatted Outputs Compatibility UpdateAuto-on25R1.2

With this release, the Generate Document From Formatted Output action in QualityOne supports the generation of both PDF and Word documents using Word Formatted Output templates. This update allows users to benefit from improved flexibility, setup, and maintenance provided by Word Formatted Output templates.

Learn more about generating documents and configuring Document Generation.

Enhance Create Audit Record & Create Proposed Audits ActionsAuto-on25R1.2

This feature enhances the Create Audit Record and Create Proposed Audits actions to improve the accuracy of field population on the generated object record.

Learn more about working with Audit Programs and configuring field population for the Proposed Audit and Audit objects.

Audit Checklist ReassignmentConfiguration25R1.3

This feature allows users to reassign the task to complete an audit checklist to another user with the Reassign Audit Checklist user action on the Audit Checklist object. With this feature, when the person responsible for completing an audit checklist is no longer available, users can easily reassign the task without the need to generate another Audit Checklist record and assign it to the new user responsible.

Learn more about reassigning audit checklists.

Audit Report Printable View EnhancementsAuto-on25R1.3

This feature introduces usability enhancements to the Audit Report Printable View feature, such as more intuitive page break behavior, increased limits for checklists questions, and optimized page width of the PDF documents.

Learn more about working with Audit Report Printable View.

QMS (QualityOne), HSE, & Training Management

Compatibility with Platform Available Answer EnhancementsAuto-on25R1.3

To ensure compatibility with Platform improvements to the Available Answer data model for checklists, we are refactoring QualityOne-specific checklist capabilities, such as the ability to create Action Items from checklists. This ensures continued efficiency, scalability, and seamless compatibility with the enhanced Platform checklist functionality.

Learn more about working with audit checklists.

RegulatoryOne

Beginning with 25R1.3 and for all subsequent releases, RegulatoryOne releases on the same date as the Veeva Vault Platform.

RegulatoryOne

Packaging Hierarchy Data Model UpdatesSupport25R1.2

This feature enhances packaging data functionality by consolidating packaging details within the Formulation object. This streamlined approach unlocks advanced features like Formulation Questionnaires and Quantitative Assessments, previously unavailable to use with packaging data.

Tree & Child Object Security on Standard Objects 25R1.2

The Tree Security and Child Object Security Platform features are applicable only for certain Veeva Vault applications and do not apply to RegulatoryOne or Veeva Claims standard objects.

Registration & Dossier Management

Create Missing Documents for Requirements from EventsConfiguration25R1.3

This feature allows users to create missing documents for Requirements for multiple dossiers from an Event by efficiently grouping Requirements that use the same document template across multiple dossiers.

Learn more about creating dossier documents from templates for an Event.

Manage Registrations from EventsConfiguration25R1.3

This feature allows users to create Registrations and Registration Objectives and populate registration data on all Registration Items associated with an Event, reducing the time and number of steps for a single user to manage dossiers at scale.

Learn more about generating registration data and creating Registrations and Registration Objectives for all dossiers associated with an Event.

Veeva Claims

Beginning with 25R1.3 and for all subsequent releases, Veeva Claims releases on the same date as the Veeva Vault Platform.

Veeva Claims

Enable Hierarchical Copy for Project Local AdaptationsConfiguration25R1.2

This feature enables Admins to configure the Copy Record action so that users can add a copied Local Adaptation to an existing linked Project. This streamlines processes where users need to link newly-copied Local Adaptations to pre-existing Projects, such as when creating copies of a regional Local Adaptation for countries within that region.

Tree & Child Object Security on Standard Objects 25R1.2

See feature description.

Selectively Create Claims Dialog EnhancementsAuto-on25R1.3

This feature introduces multiple usability enhancements for the Selectively Create Claims dialog, including an increase to the number of Statements and Products displayed.

Learn more about using the Selectively Create Claims dialog .