New in 25R2 Limited Release

Limited Release Dates: April 25, 2024 (25R1.2); May 30, 2025 (25R1.3); June 20, 2025 (25R1.4) | General Release Date: August 1, 2025

The following applications may have different release dates: Safety, RegulatoryOne, and Veeva Claims.

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

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.

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.

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.

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.

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:

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:

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
)

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.

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.

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 Word Formatted Outputs.

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 Word Formatted Outputs.

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.

User Experience

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

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

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.

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.

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.

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 fieldsAuto-on25R1.2

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.

PromoMats - Medical

PromoMats-Medical: Auto Update Anchor SupportAuto-on25R1.2

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.

Clinical Operations

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

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, Study Startup, eTMF

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

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.

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.

eCOA

Studio

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.

Reporting

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.

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)

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.

Downtime Notification Immediately Before eCOA System UpgradeAuto-On25R1.2

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.

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 Files 25R1.2

​​​​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.

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.

Medical

MedComms

Scientific Statements: Supporting AssetsAuto-on25R1.2

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.    

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.

MedInquiry

Standardization of Responses and InteractionsAuto-on25R1.2

This feature provisions objects, such as Chat and Internal Email, and fields such as Include Fulfillment Documents, Incomplete Case Requests, and more in an effort to further standardize MedInquiry.

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 EnhancementsAuto-on25R1.2

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.

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.

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.

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.

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.

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 and Periodic Review Records during Change AuthorizationAuto-on25R1.2

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 NavigatorAuto-on25R1.2

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.

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.

LIMS

Stability: Quantity Tracking & Pull Process 25R1.2

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 CreationAuto-on25R1.2

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 InputsAuto-on25R1.2

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

Stability Study Design and Study: User Interface UpdatesAuto-on25R1.2

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 SetAuto-on25R1.2

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/AAuto-on25R1.2

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 SetAuto-on25R1.2

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

Validation Management

Display Workflow Task Information In Validation Management InterfacesAuto-on25R1.2

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.

Regulatory

RIM Publishing

Singapore eCTD 1.0 25R1.2

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 ChecksConfiguration25R1.2

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.

RIM Registrations

IDMP Data Model Updates (IG V2.2)Auto-on25R1.2

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 & Bundling Validation Enhancements for Change ItemsAuto-on25R1.2

This release introduces enhancements to the Create Related Records and Bundling functionalities, 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 ItemsConfiguration25R1.2

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 Total Number of 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 sub-setting, Enable Counts of Total Events and Completed Events for Change Items, is added under the Execute Registrations SDK triggers setting. The sub-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

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:

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.

Safety

The Safety 25R1.2 release, including all Platform features, is scheduled for tentative availability on May 1, 2025. For the latest central dictionary updates for your Safety Vault, see Safety Central Dictionary Updates.

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.

Formula Expressions for Online Questionnaire Follow-up RulesAuto-on25R1.2

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.

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.

Expectedness Reevaluation for Postmarket Follow-UpsAuto-on25R1.2

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 VersionAuto-on25R1.2

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.

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.

Early Notification ReportsAuto-on25R1.2

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.

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.

DSUR: Ability to Include Fatal Adverse Events in Cause of Death ColumnAuto-on25R1.2

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.

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.

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.

Generate Case Collections from a Workbench Case SeriesAuto-on25R1.2

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.

Generate Reports from Workbench Report DefinitionsAuto-on25R1.2

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.

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.

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.

Literature Article QC SamplingAuto-on25R1.2

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.

Literature Inclusion in Aggregate ReportsAuto-on25R1.2

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

Multiple Product Families on Safety InvestigationsAuto-on25R1.2

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.

Safety & Safety Workbench

Latest Case Version in Period for Ad-Hoc Reporting & AnalyticsAuto-on25R1.2

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

Safety & Safety Signal

Individual Case Routing CriteriaAuto-on25R1.2

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.

QualityOne

QualityOne

Tree & Child Object Security on Standard ObjectsAuto-on25R1.2

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.

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.

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.

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.

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.

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.

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.

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.

RegulatoryOne

The RegulatoryOne 25R1.2 release, including all Platform features, is scheduled for tentative availability on May 6, 2025.

RegulatoryOne

Packaging Hierarchy Data Model UpdatesAuto-on25R1.2

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 ObjectsAuto-on25R1.2

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.

Veeva Claims

The Veeva Claims 25R1.2 release, including all Platform features, is scheduled for tentative availability on May 6, 2025.

Veeva Claims

Enable Hierarchical Copy for Project Local AdaptationsAuto-on25R1.2

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 ObjectsAuto-on25R1.2

See feature description.