New in 26R1 Limited Release

Limited Release Dates: December 19, 2025 (25R3.2); February 20, 2026 (25R3.4); March 6, 2026 (25R3.5) | General Release Date: April 17, 2026

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.
• 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

Doctype TriggersAuto-on25R3.2

Doctype triggers are a new Vault Java SDK entry point that allows Vault developers and customers to extend Vault document functionality. Triggers can be executed as Before or After events on document Create, Update, and Delete. Admins can view, enable, and disable custom doctype triggers in Admin > Configuration > Vault Java SDK > Document Type Triggers.

Learn more about Doctype Triggers.

Process Monitor: New Metrics & Chart OptionsAuto-on25R3.2

Process Monitor now includes additional metrics that can be displayed along the top of a Process View, and can be used for additional charts. The following new metrics are available:

• Cycle Time: Target
• Volume: Created
• Volume: Entered Start State (day, week, or month)
• Volume: Entered End State (day, week, or month)
• Quality: Completed on Time (count or percentage)
• Quality: Completed Late (count or percentage)
• Quality: Number of Variants

The new Number of Variants metric is now available in all new Process Views by default. Existing Process Views created prior to 26R1 will not have this metric automatically added.

You can add these new metrics using the Metrics button:

You can set the Target value using All Actions > Settings:

Each Process View supports up to ten metrics.

You can now also use any available metrics in additional custom charts:

Learn more about Process Monitor.

Managing Documents

New CrossLink Source TypeAuto-on25R3.2

CrossLinks can now sync the source document’s source file in addition to the viewable rendition when configured for that document type. In the target Vault, a new document type setting, CrossLink Source Type, determines if CrossLinks created under that type will use the source document’s source file and viewable rendition, or just the viewable rendition.

This enhancement is intended to improve sharing more interactive file types across Vaults, such as CLM presentations or SCORM files. In these cases, only having the PDF viewable rendition is not sufficient for the files to be appropriately used in target Vaults.

If CrossLink Source Type is set to Source document’s source file and rendition, both the source file and rendition are synced based on the Source Binding Rule set on the document. By default, the CrossLink Source Type setting on the Base Document (base_document__v) document type is set to Source document’s rendition, in line with existing CrossLink behavior.

Learn more about CrossLinks.

Allow Custom Renditions on CrossLink DocumentsAuto-on25R3.2

Users can now manually add renditions to CrossLink documents just like they can for any other regular document. Renditions are not pulled or synced from the source Vault document. The standard viewable rendition remains read-only for CrossLinks, but other rendition types can be added if configured on the document type.

In the following example, a custom rendition is assigned to the Finance document type:

Users now have the option to use that rendition type to manually add a custom rendition to a CrossLink for that document type:

Any manually added renditions are not affected when CrossLinks are updated based on changes to the source document. Manually added renditions on the source document are not pulled forward to the CrossLink.

Learn more about CrossLinks and Managing Rendition Types.

Enhanced Field Update Behavior for Document Creation Event ActionsAuto-on25R3.2

Update field actions for Create Document and Create Copy event actions are now applied before a document is created. This allows documents to be created with empty required fields if an event action populates the required fields.

Document creation in Vault is currently blocked if an empty required field is intended to be populated by an event action. With this feature, documents can still be created, because their value will be set by the event action during creation. Event action behavior for Create Draft event actions remains as it is today, so any fields set by an Update field action in a Create Draft event action will be set after version creation, not before.

Learn more about Event Actions.

Managing Data

Word Formatted Outputs: Display Rich Text Values Using Microsoft Word FontAuto-on25R3.2

When using Rich Text fields in Word Formatted Outputs, the output font will now match the Word font settings by default. Other rich text formatting, such as bulleting, font color and font size, will be respected.

Prior to 26R1, Rich Text fields would be rendered in a Word Formatted Output to match how the field appears in Vault, which could create inconsistent formatting when the Word file’s font differed. This enhancement ensures consistent formatting by default.

In some cases, it may be preferred to use the font from Vault, and this can still be achieved by appending “vaultfont” to the field token:${rich_text__c;vaultfont}.

Learn more about Managing Word Formatted Output Templates.

Word Formatted Output: Tokens for Object Label, Object Description & Relationship LabelsConfiguration25R3.2

Word Formatted Outputs now support tokens for object label, object description, relationship labels, and field descriptions. This enhancement allows templates to reference object and relationship information dynamically.

For instance, if a template references an object label directly, such as Corporate Initiative, and the object label is updated in the future, the Word template would require manual updating as well.

Going forward, this can be referenced through a token in the template, and if the label changes, no template updates are required. Additional supported tokens include:

• ${object;label}
• ${object;description}

For these tokens, the object label or description that is pulled will be based on the context. For instance, if the ${Rowset()} for a given table is ${Rowset(projects__cr)}, then these tokens would return the label and description for the Project object. If used outside of a ${Rowset()}, these tokens would return the label and description of the root object.

Additional tokens are also available supporting outbound relationship labels and field descriptions:

• ${relationship_name__v;label}
  • For outbound relationships, this token resolves to the field label that defines the relationship

• ${field_name__v;description}
  • Please note that field labels are already supported prior to 26R1

.

Learn more about Managing Word Formatted Output Templates.

Checklist: Allow Other Participants in Checklist WorkflowsConfiguration25R3.2

The Participants control in the Start step of Accepted and Pending Acceptance Checklist workflows now allows additional configuration options. Other Start step configuration options, such as the Instructions and Date controls, are not supported. Newly supported Participants control options include:

• Use roles as participants (already supported in Pending Acceptance workflow; now also supported in Accepted workflow)
• Use custom action to define participants
• Use user reference field as participant
• Use Vault user groups as participant

The following configurations remain unsupported:

• Allow workflow initiator to select participants
• Allow workflow task owner to select participants

Prior to 26R1, the Accepted workflow only supported Owner (the workflow initiator), and the Pending Acceptance workflow only supported Checklist Respondent through Use roles as participants. This enhancement provides more flexibility to allow additional participant groups to be part of checklist workflows.

User Experience

Streamlined Multi-Vault NavigationAuto-on25R3.2

Users with access to multiple Vaults can now more easily open a different Vault in a new tab from the Vault Selector or the My Vaults page. Users also no longer receive a session expired error when one tab switches to a Vault that was already open.

Vault names are now hyperlinks that users can right-click to leverage the browser’s available options for opening in a new tab or window. This helps improve the user experience when working across multiple Vault environments.

Additionally, when opening the Vault Selector, a user’s cursor will now immediately display in the Search bar, and once a search is performed, the user can use the down arrow to immediately select the desired Vault. This enhancement streamlines Vault switching for more keyboard-focused users.

Optimized Record Detail DisplayAuto-on25R3.2

Optimized Record Detail Display optimizes the record detail page experience by prioritizing the most useful expanded section first, then asynchronously rendering the remaining content after the page becomes visible and interactable for users, improving the user’s perceived performance.

Although Admins cannot configure multiple sections to expand by default on initial load, Vault remembers which sections were previously expanded by the user on subsequent loads. By prioritizing the most important section to render first, then rendering the rest of the expanded sections later in an asynchronous manner, we can make the performance better for general users.

Analytics

Execute Reports with Columns with Field Level SecurityAuto-on25R3.2

Vault now automatically hides columns in reports and dashboard charts that a user doesn’t have access to due to field-level security. Prior to 26R1, if a user didn’t have access to a particular field used as a column, they would not be able to access the report at all. This enhancement ensures that users can see what they are allowed to see without needing to create duplicate reports with different sets of columns.

Users may still encounter access errors if the inaccessible field is used in report or dashboard logic, such as Group By, Formula Fields, Conditional Fields, or dashboard chart criteria.

This enhancement specifically applies to field-level security applied using permission sets for objects or via security overrides for documents. Fields secured using Atomic Security for objects already do not prevent access to the overall report.

Learn more about Field Level Security for Documents and Field Level Security for Objects.

Support Legacy Users in Workflow and Lifecycle FormulasAuto-on25R3.2

Admins can now add Created By and Last Modified By fields in Lifecycle and Workflow formulas.

Admin Experience

Searchable Object Fields Admin UI UpdateAuto-on25R3.2

The Searchable Object Fields page in Vault Admin is updated to improve usability. The Name (name__v) field is no longer displayed, since this field is always searchable and cannot be removed. This enhancement makes the list of optional searchable object fields easier to review.

Users can add or remove multiple fields before committing. Two new pending states are introduced: Uncommitted Removal and Uncommitted Add. Once items are modified, the user can select Commit Changes to complete the process and initiate reindexing, or Revert Changes to discard them.

Picklist Order TypeAuto-on25R3.2

A new attribute on picklists allows Admins to specify how picklist entries are displayed to users. It allows picklist values to be returned in alphabetic order by the picklist value of the user’s language, instead of using the predefined picklist order. This new attribute can be set on the picklist in Business Admin or using MDL.

Learn more about Managing Picklists.

Create Inactive Users in Migration ModeConfiguration25R3.2

Admins can now create inactive Vault users associated with inactive domain users by leveraging Record Migration Mode. Inactive vault users do not consume a license until they are activated.

Permissions & Access

New Permission to Access Root File Staging FolderAuto-on25R3.2

A new permission is now available for configuration in permission sets to grant users the ability to access the root folder on the file staging server. Prior to 26R1, only standard System Administrator and Vault Owner security profiles allowed access to the file staging server root folder. This new permission allows customers to assign the permission more granularly in line with the principle of least privilege.

By default, this new permission is enabled in the standard System Administrator and Vault Owner security profiles to maintain current behavior.

Learn more about Accessing Your Vault’s File Staging Server.

Vault-On-the-Go

Document Scanner Improvements for Android DevicesAuto-on25R3.2

Scanning documents on Vault Mobile on Android devices has been improved to provide better quality scans, automated page detection, and image clean-up. These improvements greatly reduce user effort in adjusting scanned images manually and brings the quality of the Android app scanning on par with the iOS experience.

Learn more about Vault Mobile.

Veeva Connections

Clinical Operations - EDC

Clinical Operations-EDC Connection: Visit Review Progress Indication 25R3.2

The Clinical Operations-EDC Connection previously provided a limited view of Source Data Verification (SDV) and Data Monitoring Review (DMR) progress as binary state: either Complete or Not Started. This lack of granularity created ambiguity, specifically if a CRA started reviewing a subject visit but could not finish it (for example, due to time constraints or needing clarification). The system did not reflect the partial work. This often led to misrepresentation of data review status, making it impossible for study managers to get an accurate, real-time snapshot of the overall monitoring progress.

To resolve this, the Veeva CTMS data model is extended to in this release include two new dedicated fields for granular review tracking: SDV Status and DMR Status, each supporting the three states (Completed, In Progress, and Not Started) across the relevant subject visit objects.

This feature specifically enhances the Clinical Operations-EDC Connection to populate these new Veeva CTMS fields based on SDV & DMR performed in Veeva EDC.

Note that SDV/DMR Mode, SDV/DMR Completed, and SDV/DMR Complete Date will still be populated by the Clinical Operations-EDC Connection and used by Veeva Payments to ensure continuity of previous functionalities.

This feature enables Veeva CTMS to reflect the Review status without requiring manual entry from CRA in Veeva CTMS, ensuring synchronization with the Veeva EDC source.

Learn more about other new Clinical Operations features below.

Clinical Operations-EDC Connection: Flexible Visit DefinitionsAuto-on25R3.2

This feature streamlines the process of connecting Visit Definitions between Veeva CTMS and EDC by removing the manual linking requirement, making study connection easier and less technical.

When a study is connected, the Clinical Operations-EDC Connection is now enhanced to automatically link existing CTMS Visit Definitions to their corresponding EDC records using the Visit Definition name. This eliminates the need for users to manually link existing records using the EDC Private Key and Study ID.

The updated logic is:

1. The Clinical Operations-EDC Connection first checks if there is an existing Study Visit Definition with a matching link. If found, the existing record is updated from the source.
2. If no link is found, the system then checks for a Study Visit Definition that matches on Visit Definition name (case sensitive). If a match is found, the system automatically creates a link and updates the existing record from the source.
3. If no match is found by link or name, a new Visit Definition record is created and linked.

If the system finds more than one Visit Definition with the same name, the record is not processed and a User Exception Message is created.

Existing Visit Definitions that are already linked are not impacted by this feature.

Learn more about other new Clinical Operations features below.

Clinical Operations-EDC Connection: Identify Programmatic Protocol DeviationsAuto-on25R3.2

When managing Protocol Deviations (PDs) in CTMS, a critical distinction for oversight, workflow, and data integrity is understanding the PD’s origin. Was it created automatically by the system (a programmatic PD) or manually by a user?

Prior to this enhancement, the existing Clinical Operations-EDC Connection would transfer PD records from Veeva EDC/CDB to Veeva CTMS, but it lost the key piece of information indicating if the PD was created via an automated rule (for example, “If participant age < 18,” “If visit date is outside of window”).

This feature enhances the existing Clinical Operations-EDC Connection to automatically identify and label Programmatic Protocol Deviations upon creation in Veeva CTMS. The Protocol Deviation object type pdv__ctms has been extended with a new system-managed field programmatic__v. The connection logic is also updated. For any source PD record in Veeva EDC, if it was automatically created by a rule, the connection will automatically mark the target programmatic__v field in Veeva CTMS as Yes.

This enhancement ensures that PDs created in Veeva EDC through a Rule Definition are now accurately identified as a Programmatic Protocol Deviation when created in Veeva CTMS. This new Programmatic label is then available in Veeva CTMS for downstream usage (e.g. other features, reporting), allowing study managers to easily distinguish system-generated versus manual issues.

Learn more about other new Clinical Operations features below.

Safety - EDC

Safety-EDC Connection: Send Additional SAE Reporter Details to SafetyAuto-on25R3.2

This feature enhances the Safety-EDC Connection: Send SAE Reporter Details to Safety feature by sending additional reporter details. The Safety-EDC Connection now transfers reporter email address and telephone values, reducing the overall time required for initial Serious Adverse Event (SAE) triaging and follow-up processing.

Learn more about other new Safety features below.

Safety-EDC Connection: Support Case Product Type ChangesAuto-on25R3.2

The Safety-EDC Connection introduces flexibility in record matching specifically for Inbox Items and Cases originating from EDC. The connection now allows matching and merging for records with different types of Case Products. Previously, the Inbox Item to Case Compage page prevented users from merging when the existing record and the incoming EDC record had different Case Product object type values, even when all other criteria matched. This prevented potential data loss from fields that might exist for one object type but not the other. For records sourced from EDC, Vault now proceeds with the merge despite object type mismatches. Any field values on the source record that do not exist on the destination record will not merge to the destination record during the merge process.

This enhancement ensures that users can merge Cases generated by the Safety EDC connection with matching Link values and differing Case Product types to existing records. This significantly improves the success rate of automated matching and merging for EDC data, reducing the need for manual intervention and accelerating case processing workflows.

Learn more about other new Safety features below.

Safety - RIM

Safety-RIM Connection: Create Product SubstancesAuto-on25R3.2

This feature enhances the Safety-RIM Product Connection to streamline and automate how Safety Vaults manage substance information by generating product-level substance data, significantly reducing manual data entry. Vault updates all Products in a Product Family with the Product Family Substance details received from RIM. Previously, Vault only transferred Product Family-level substance details and Safety users had to manually add those details to each applicable Product.

This enhancement ensures that Safety Vaults have the necessary Product-level Substance data for critical downstream functions, most notably substance-based cross reporting of adverse events. It provides constant alignment of Product Substances based on Product Family Substances as users add, edit, and remove data from a Product Family in RIM Vaults. For example, when a RIM user associates a Product to a Product Family or modifies a Substance associated with a Product Family, Vault automatically updates the associated records in Safety to synchronize the data in both Vaults.

In addition, Safety users can run the Sync Substances action on Product Families to manually trigger the substance alignment logic for a Product Family and all its related Products.

Learn more about other new Safety and Regulatory features below.

Safety-RIM Connection: Updated Product Dose Form SyncingAuto-on25R3.2

This feature updates how Safety Vaults manage Product dosage forms to align with the Veeva RIM data model, which now supports multiple dosage forms per Product to meet evolving IDMP requirements. The new data model ensures regulatory compliance in RIM Vaults by allowing users to accurately tag a single Product’s dosage forms as either the global preferred term or a country-specific exception, covering terminology variations across markets for the same product. This data model alignment ensures accurate Product information in Safety Vaults.

This feature introduces the Product Manufactured Dosage Form object to Safety Vaults, allowing users to track multiple dosage forms (including the preferred and any exception terms) for a single Product. This object stores all associated dosage forms transferred from RIM. While a Product can now have multiple dosage forms, Vault selects the most appropriate single dose form (based primarily on preferred term status) to populate the Dose Form field on related Product Registrations. This single-value continuity ensures existing downstream logic and reports continue to function smoothly.

Learn more about other new Safety and Regulatory features below.

Clinical Operations

Features in the Veeva Connections section also affect the Clinical Operations application family.

All Clinical Operations Applications

Autofill Site Timezones from Global DirectoryAuto-on25R3.2

For global clinical trials, the timezone of the Study Site is required information for the Site Profile in Veeva EDC. This is because the system needs the timezone for important functions, like knowing when to activate new Study Rules or using the correct local lab ranges.

However, the Timezone is optional in Veeva CTMS. If a Site was set up or changed in CTMS without a Timezone, the automatic transfer of this Site information to EDC would fail because EDC needs the Timezone.

This failure caused errors and delays in setting up Study Sites in Veeva EDC, creating extra work for the study teams.

This new feature addresses the data completeness and integration challenges by introducing automated logic to populate the Study Site Timezone, ensuring critical data is consistently present for EDC integration.

In Veeva CTMS, the Global Directory Organization object now includes a Timezone (timezone__v) field. When creating or updating a Study Site record, Vault automatically populates the Study Site Timezone according to the following rules: 

• Auto-population will occur if the Study Site’s Timezone field is empty, using the Timezone of the linked Global Directory Organization record, or when the Organization is updated on an existing Site record.
• User control is maintained, as the system will not overwrite an existing or manually entered Timezone. Users are also allowed to change an auto-populated Timezone on Site records.

This feature minimizes the risk of Study Sites being created without a Timezone, thereby preventing connection errors caused by missing Site Profiles and streamlining the site setup process in Veeva EDC.

CTMS

Site Engagement Management: Activity EnhancementsAuto-on25R3.2

The existing Activity object, while originally intended for integration with Clinical CRM, has been broadly adopted by many customers as a critical tool for logging interactions, meetings, and communications related to trial sites and studies. However, due to its intentionally simple initial data model, the Activity object was lacking the necessary structure to capture the full details of real-world site engagement. This resulted in either a partial recording of the site engagement, or requiring customers to build custom solutions to capture additional information.

We have enhanced the Activity data model to support the industry’s growing need for more detailed and flexible engagement tracking. The key updates focus on breaking down rigidity and adding granularity:

• New Fields for Context: The Topic, a multi-select picklist for logging multiple conversation subjects, and Sentiment, a picklist rating for indicating the interaction’s tone, fields have been added.
• Proactive Planning: The Person field is now optional, allowing users to plan Activities even when the specific attendee is yet to be confirmed.
• Multiple Attendees: A new Attendee child object allows users to associate multiple people to an Activity, including individuals not listed in the Global Directory.
• Multiple Study Discussions: A new Discussion child object allows users to link multiple Studies to one Activity, making it easy to log a single meeting while distinguishing specific details relevant to different studies.

These enhancements provide CRAs and Site Engagement Leads with the necessary flexibility to accurately capture detailed site interactions and ensure a complete record of engagement in Veeva CTMS.

UI Enhancements for the Study Enrollment Status GraphAuto-on25R3.2

This feature significantly enhances the Study Enrollment Status Graph on the Study Manager Homepage, providing better filtering, forecasting, and user interface elements.

Key Enhancements

• Subject Group Filtering: Users can now filter the graph to view Enrollment Metrics specific to a Subject Group. This filter is dynamically available only if the Study contains Subject Groups where Enrollment Metrics are tracked, and the user has the necessary view access to the records. Selecting a Subject Group dynamically updates the graph to display only the relevant metrics. 
• Improved Enrollment Forecasting: The graph now displays Forecasted Enrollment lines in addition to Planned and Actual values. This enables users to perform a more complete and forward-looking comparison of study performance against overall enrollment goals. 

These updates deliver a more flexible and informative Enrollment Status Graph for monitoring ongoing study performance.

Bulk Copy Issue to Multiple SubjectsConfiguration25R3.2

During a clinical trial, it is common for a single protocol deviation (PD) or site issue to impact multiple subjects. For effective oversight and also accurate data quality management, the industry practices usually recommend one issue record (such as Protocol Deviations) to correspond to exactly one subject impacted. 

Prior to this feature, if for example a CRA needed to log the same issue against ten different subjects, they had to manually create and link ten separate Issue records. This repetitive, time-consuming process was inefficient and prone to manual error. Furthermore, this lack of a streamlined solution carried the significant risk of failing to document one Issue record per Subject necessary to achieve the required granular oversight.

This new feature introduces the Bulk Copy Issue object action, which facilitates the creation of identical Issue records for multiple affected Subjects at a single Site. This user-driven action works as follows:

• The user (such as a CRA or Study Manager) selects an existing Issue record and executes the Bulk Copy Issue action.
• A multi-select dialog then appears, displaying only the active Subjects at that Site, allowing for precise targeting.
• Upon confirmation, the system automatically generates a new Issue record for each selected Subject. The system ensures that the field values from the original Issue record are copied and simultaneously updates the subject-specific reference fields, Subject and Subject Group, with the data of the newly selected Subject.

This enhancement removes the inefficiency of manual copying and guarantees the necessary granularity for accurate data quality management and oversight.

Updated Seeding Logic for Closed Issues in MonitoringAuto-on25R3.2

This feature updates the logic for the Seed Issues action for Monitoring Events. The system now considers the Issue record’s Date Identified value instead of the Created Date when seeding Closed Issues into Monitoring Events.

SDV Status Support for Subject VisitsAuto-on25R3.2

For Clinical Research Associates (CRAs), a primary task is Source Data Verification (SDV) or Data Monitoring Review (DMR) performed during monitoring visits. Previously, Veeva CTMS only tracked SDV as a binary state: Complete or Not Started. This lack of granularity created ambiguity. When a CRA had to interrupt their reviews (such as pausing work on a Subject’s records to travel or address an urgent issue) they had no means to accurately record the effort already initiated. This resulted in documentation where substantial in-progress SDV or DMR work was effectively invisible, making it challenging for CRAs to report precisely on their activities in their Trip Reports and for study managers to accurately gauge true monitoring progress and allocate resources efficiently. 

To resolve this issue and provide CRAs with precise documentation capabilities, the Subject Visit and Unblinded Subject Visit objects have been updated to include new fields: SDV Status and DMR Status. These fields use a new Review Status picklist with the following options: Complete, In Progress, and Not Started. This change allows CRAs to move beyond the binary status and accurately document partial or in-progress SDV/DMR efforts directly on the visit records. This ensures that their Trip Reports accurately reflect the time and work spent, dramatically improving the visibility and accountability of the monitoring process. 

This new functionality also aligns with our EDC-CTMS connection model, enabling the seamless and granular transfer of SDV and DMR status from Veeva EDC to our Veeva CTMS.

Subject Group & SDV Status in Monitored Subject DataAuto-on25R3.2

The Seed Monitored Enrollment actions automatically populates the Monitored Subjects and Monitored Subject Visit objects by copying relevant Subject and Subject Visit data for a Site, significantly reducing manual data entry for the CRA during a monitoring event.

This new feature enhances the core value of the Monitored Data concept by ensuring accurate, automatic data alignment during the seeding process. We have upgraded the Proactively Seed Monitored Enrollment and Seed Monitored Enrollment actions to automatically transfer two key pieces of information to the appropriate monitoring records: 

• SDV Status and DMR Status (including the new In Progress state) from the Subject Visit to the Monitored Subject Visit record 
• Subject Group details to both the Monitored Subject and Monitored Subject Visit records

CTMS, Study Startup

Auto-Populate Last PSV Date on LocationAuto-on25R3.2

This feature automates the population of the Last PSV Date (last_psv_date__v) field on the Location object for a Study Site’s primary location. The field is updated with the Actual Finish Date of the latest completed Monitoring Event milestone where the Milestone Type is Pre-Study Monitoring Visit (pre_study_monitoring_visit__ctms), ensuring the date always reflects the most recent PSV completion.

Disclosures

Move CTN Setting to New Disclosures SettingsAuto-on25R3.2

The Enable Japanese CTN Feature flags in Admin Settings have been moved from CTMS Settings into a new Disclosure Settings section, to reflect that Japanese CTN Functionality is included with Disclosures.

eTMF

Delete CrossLink Document After Archival SnapshotAuto-on25R3.2

To prevent orphaned documents after taking snapshots, CrossLinked documents are now deleted from the Library following Study Archival if only a single Study is tagged across all versions of the document. The document deletion is delayed approximately 5-15 minutes after archival, once the snapshot is successfully saved to the Archive. If the CrossLinked document is tagged to more than one Study across its versions, it will remain, and only the connection to the archived Study will be removed.

Add Signature Page to Document SnapshotsAuto-on25R3.2

Exported or Archived documents will now consistently include the associated Signature Page in the Snapshot and exported file. This ensures the necessary Signature Page is available for review, even when the original document is associated with multiple studies.

eTMF, Study Startup

Subartifact Value Auto-Populates When Using Drag & Drop on Expected DocumentAuto-on25R3.2

When using drag & drop functionality to upload documents to Expected Document records with Subartifact populated, the Subartifact metadata field on the document will also be automatically populated with the corresponding value, aligning with the behavior of other field defaults.

OpenData Clinical

Create Excluded Record from Resolved Data Change RequestAuto-on25R3.2

This feature extends the existing Create Missing Record action to be used on resolved Data Change Request (DCR) records that were rejected due to the requested record’s exclusion from OpenData Clinical. This action enables users to create the excluded Investigator or Institution record directly from the resolved DCR and have full control over the record as it is not linked to OpenData Clinical.

Payments

Automated Adjustment: Amount OverrideAuto-on25R3.2

This feature introduces the ability to exclude the Amount and Currency fields from the Automated Adjustments evaluation process. A new picklist value, Amount Manually Adjusted, has been added to the Adjustment Override field on the Payable Item object. When a Payable Item has this override set, the system ignores the Amount and Currency fields during the adjustment evaluation process. Changes to other fee matching criteria (such as Visit Status or Visit Date) remain valid and continue to trigger Automated Adjustments. If adjustments are required for items in a Payment Request, the new Adjustment Payable Item reflects the manually entered amount and currency of the original Payable Item, rather than the original Fee. 

With this change, customers can now support scenarios like post-contract currency updates and payment for partial subject visits. 

This feature is auto-on for customers with Automated Adjustments enabled. 

Fees Support Multiple Subject Groups of the Same Type Auto-on25R3.2

This feature introduces enhanced flexibility in defining fees by allowing a single Fee or Fee Template record to be associated with multiple Subject Groups (such as arms and cohorts). This change eliminates the need to create several identical fees for groups that share the same payment terms. 

The new Fee Subject Group and Fee Template Subject Group join objects are available to link multiple Subject Groups to a single Fee or Fee Template, respectively. During Payable Item generation, the system evaluates both the existing single Subject Group field values on the Fee and the values defined in the new join object records based on the following:

• Subject Group fields: The Subject Visit or Procedure must match the value specified in these fields (if defined).
• Fee Subject Groups: The Subject Visit or Procedure must match at least one of the related join object records. 

For example, a Subject Visit in Study Arm A and Cohort 1 will successfully match a Fee where the main Study Arm field is set to Arm A and the related join records include Cohort 1. 

Fee Template Subject Group and Fee Subject Group records are copied when executing the Copy Record with Related Fees action, ensuring this information is maintained when duplicating schedules.

This enhancement significantly streamlines fee schedule management for complex trials.

Site Connect

Delete Expired PALAuto-on25R3.2

Public Access Link (PAL) records are created by the system for external users to access the appropriate Site Connect documents and data. 

The system managed objects included are: 

• PAL Site Connect Document Viewer (pal_site_connect_doc_viewer__v)
• PAL Site Connect Bulk Document Download (pal_sc_bulk_doc_download__v)
• PAL Site Connect Login (pal_site_connect_login__v) 

These PAL records expire after one year and to reduce unnecessary buildup, a new daily job will run to automatically delete expired Public Access Link records.

Automatic Safety DistributionsConfiguration25R3.2

This feature introduces an automated Safety Distribution process streamlining the process of sending safety documents. Safety Distribution records can now be automatically created when documents are created or modified and the new Automatic Safety Distribution document field is set to true.

This is possible through configuration of the new Generate Safety Distribution action as an Event Action or Entry Action on the document lifecycle. When the action is triggered, a new Safety Distribution record is created based on predefined mappings of the new Safety Distribution Default Mapping object that match document fields such as Classification, Safety Distribution Type and any custom fields.

Finally, a separate Distribute Safety Letters record action will be available for configuration within Safety Distribution workflows, which automatically sends the safety document to all applicable Study Sites based on the Safety Distribution Defaults configured.

Distributed Sites AttachmentAuto-on25R3.2

When a Safety Distribution is triggered manually or automatically with the new Automatic Safety Distributions functionality, the system will now automatically generate and attach a CSV file to the Safety Distribution record, detailing the list of Sites included in that distribution for improved tracking and auditing.

Additionally, all Safety Distributions that are in a Failed state are now visible in the UI across Site Connect and Document Exchange grids for better visibility and management, and can be marked as Read by recipients.

Study Training

In addition to the features described below, the Study Training application also received enhancements from the following features described in the Quality: Training section:

• Quiz: Support Multiple Choice Dropdown Questions
• Training Focus Time

Study Training Matrix Builder: Remove SectionsAuto-on25R3.2

With this feature, users can now delete sections in the Study Training Matrix Builder. When the Highlight Proposed Changes button is toggled, the builder additionally highlights these removed sections. 

Sections can only be deleted when Training Requirements are not checked for assignment within that section, even in draft. When Training Requirements are checked, the delete option is inactive and a tooltip explains the reason. Prior to deletion, the builder displays a warning message.

Commercial

PromoMats

eCTD: Enhanced Support for Video/Audio FilesAuto-on25R3.2

Veeva PromoMats now supports the regeneration of eCTD Compliance Packages when a video/audio file has been added to the Compliance Package as the main promotional material. Previously, regeneration was not supported when these types of files were added as the main material.

Claims: Hierarchical CopyAuto-on25R3.2

When you make a copy of a Claim, Veeva PromoMats will now provide you with the option to copy additional related records. Previously, when copying a Claim, you would only be able to copy related Match Text Variations and the Link Targets (References) for the Claim. With this release, we have extended this capability to allow you to copy the additional related Country, Product, and Indication values. This will allow you to make full copies of Claims more easily and efficiently. Learn more about Copying Object Records.

Brand Team Group ManagementConfiguration25R3.2

You can now manage memberships of user-managed groups from the Team object. Adding a Team Assignment Group record to a Team Assignment provides the security for that assignment. Users added as Team Members with that assignment will automatically be added to the specified user-managed group.

Modular Content: Additional Document Info Panel EnhancementsAuto-on25R3.2

With this release, you can now add Content Module Combinations to the Modular Content section of the Doc Info Panel, making it easier to indicate if a Material was constructed using a specific combination of assets from a Content Module. This release also includes improved keyboard navigation for accessing all assets within each Content Module.

Updated Brand and Country Page LayoutsConfiguration25R3.2

This feature updates the Brand and Country page layouts to use the newer Layout Profile Detail view in PromoMats and Medical Vaults to provide consistency with the look and feel of the rest of Vault.

Premarket Boxed Warning Detection for Quick Check AgentAuto-on25R3.2

Admins can now configure a field on the Product object to mark it as a Boxed Warning product, even if it does not yet appear in the FDA’s official database. This allows Quick Check Agent to identify and assess the presence and correctness of Boxed Warnings on documents related to the indicated Brand.

Multichannel

PromoMats: Layout Profile Detail View for CRM Rendition SettingsAuto-on25R3.2

This feature introduces a new Layout Profile Detail view for CRM Rendition Settings. This provides a consistent look and feel for configuration screens, offering a smoother and more unified experience within the PromoMats Vault.

Medical

MedComms

Scientific Statements: Hierarchical CopyAuto-on25R3.2

When you make a copy of a Scientific Statement record, Veeva MedComms will now provide you with the option to copy additional related records. Previously, when copying a statement, you would only be able to copy related Match Text Variations and the Link Targets (References) for the Scientific Statement. With this release, we have extended this capability to allow you to copy the related Statement Assets (such as Images) and the additional related Country and Product values. This will allow you to make full copies of Scientific Statements more easily and efficiently. Learn more about Copying Object Records.

Multichannel

Medical: Layout Profile Detail View for CRM Rendition SettingsAuto-on25R3.2

This feature introduces a new Layout Profile Detail view for CRM Rendition Settings. This provides a consistent look and feel for configuration screens, offering a smoother and more unified experience within the Medical Vault.

Quality

QMS

Quality Automated Language TranslationsConfiguration25R3.2

Organizations typically capture product quality complaint data in the reporter’s local language, and translate the information into English for complaint triage. This feature helps expedite the complaint capture and triage process by automating translation of complaint information from a reporter’s local language into English. The original and translated information is saved in separate text fields on Complaint Intake, Complaint, and Quality Event Complaint records. Quality users can search, report, and perform Record Checks for duplicates or recurrences based on the original and translated text field values.

Translation happens instantly whenever the new Translate Record action runs. New standard Title (Translated) and Description (Translated) fields on the Complaint, Complaint Intake, and Quality Event Complaint objects store the translated values of the Title and Description fields.

Admins can configure the Translate Record action as a user action or entry action. The Translate Record entry action translates a record when it reaches a certain lifecycle state. The Translate Record user action allows a Quality user to initiate the translation process by selecting a menu option like the one shown below for a French user.

Admins can specify the source fields to be translated and the target fields that store the translations on a Quality Language Translation configuration. Up to five source and target field combinations can be configured. Source and target fields must be Text, Long Text, or Rich Text fields, and can be standard or custom.

This feature requires configuration by an Admin.

Supplier Questionnaires: Follow-Up & Invite RespondentsConfiguration25R3.2

A Supplier Questionnaire is often used by life sciences organizations to gather information about a supplier’s business, capabilities, compliance, and risk profile. Companies utilize questionnaires in a variety of situations, including supplier onboarding and qualification, supplier risk assessment, compliance with regulatory statutes and guidance, sustainability programs, and periodic supplier re-qualification and audits.

This release introduces several key enhancements to the External Collaboration for Checklists feature to support a review and follow-up process, including the ability to send a questionnaire to additional external Supplier Respondents.

Invite Respondents

When a Quality user in your organization initiates a Supplier Questionnaire checklist on a supplier’s External Organization record, Vault grants access to the checklist and sends it to the Supplier External Collaborator.

However, in many cases, the Supplier External Collaborator needs support from Subject Matter Expert (SME) colleagues to respond. Previously, the Supplier External Collaborator had to collect responses from SMEs outside of Vault, then transcribe their responses into the questionnaire. This feature eliminates the need for offline responses by allowing the Supplier External Collaborator to invite SME colleagues to enter their responses by clicking the Invite Respondents button.

When the Supplier External Collaborator clicks the Invite Respondents button, a dialog displays containing a default message that the Supplier External Collaborator copies and pastes into an email sent to SME colleagues, modifying the message as needed.

The link included in the message only provides access to the Supplier Questionnaire and nothing else inside your Vault. SME respondents do not need to authenticate with a username and password to access the questionnaire. The link remains active until the questionnaire is complete.

The screenshot below shows how a Supplier Questionnaire appears to an SME respondent.

Follow-Up

After providing all responses, the Supplier External Collaborator sends the checklist back to your organization. A reviewer designated by your organization receives the questionnaire and can initiate a process to review all of the responses.

Prior to this feature, if a response from a supplier was insufficient, it was not possible to send the Supplier Questionnaire back to the supplier to provide additional information. This feature enables a reviewer at your organization to request more information for any question by clicking the Follow-up button and leaving a question.

When all follow-ups have been added, the Supplier Questionnaire is sent back to the Supplier External Collaborator. The Supplier External Collaborator can provide responses to follow-ups and invite colleagues to address follow-ups via the Invite Respondents button. When all follow-ups have been addressed, the Supplier External Collaborator sends the checklist back to your organization for re-review.

This back-and-forth collaboration of follow-up requests continues as needed, until the reviewer indicates the questionnaire is complete.

This feature requires configuration by an Admin.

QMS Change Related Object Lifecycle State Action: Allow Download of Failed RecordsAuto-on25R3.2

Organizations relying on the QMS Change Related Object Lifecycle State entry action now have additional actionable information should the action fail to update a record’s lifecycle state. Prior to this release, such a failure would require a user to manually review which records did not update appropriately, or to contact an Admin to review administrative logs for this information. Now, however, Admins can utilize the new QMS Change Related Object State Failed message to send the user who initiated the action a list of all records that failed to update, complete with the reasons for that failure, so that the business team is empowered to take corrective actions. This functionality is automatically enabled.

Standalone CAPAConfiguration25R3.2

This release introduces the ability to initiate Root Cause Analyses and Investigations directly from Continuous Improvement (continuous_improvement__v) records.

Introducing Standalone CAPA to Veeva QMS

This feature introduces support for a more robust Standalone CAPA process in Veeva QMS. It provides clear configuration and operational clarity for organizations utilizing both proactive activities (Continuous Improvements) and event-driven activities utilized when existing CAPAs for a closed quality event are ineffective or incomplete (standalone CAPAs).

Prior to this release, Continuous Improvement records were intended to support scenarios which were proactive changes that did not require an Investigation or Root Cause Analysis. As such, the Continuous Improvement object did not support a standardized approach for tracking these operations on Continuous Improvement records. This created a challenge for organizations needing to follow up on closed events which had CAPAs that were ineffective in resolving the core business issue represented by the event. In these follow-up cases, one must:

• Preserve the original CAPA or event data, which is now closed and locked.
• Perform additional Investigations and Root Cause Analyses to determine the remaining issues to be resolved.

To these ends, organizations can now leverage the existing Source picklist field on the Continuous Improvement object to distinguish if a given Continuous Improvement is either proactive, or in response to ineffective CAPAs on an existing event. The new Standalone CAPA fields on the Root Cause Analysis and Investigation objects directly reference Continuous Improvement records. Using these fields together, organizations can now configure Vault to use the single Continuous Improvement object to either capture truly proactive actions, or, if the Source field is so populated, to guide users to create and execute Investigations and Root Cause Analysis for the event-driven follow-up actions of standalone CAPAs.

This feature does not introduce any changes to the existing Continuous Improvement object’s label or object types. To adopt the standalone CAPA approach, organizations can activate the new Standalone CAPA fields available on the Root Cause Analysis and Investigation related objects, and leverage the Source field and layout configurations to show or hide Investigations and Root Cause Analysis sections on Continuous Improvement records.

Reason for Change EnhancementsAuto-on25R3.2

This release expands support for the Reason for Change feature to Recurrence Check Insights and Action Paths. It also introduces a new constraint on Reason for Change configurations.

Pre-Release Testing Consideration: Users may encounter an error when attempting to update a record’s field if the field is subject to a Reason for Change configuration. This is a result of the new Reason for Change configuration constraint described in the Reason for Change Capture Field section below. Customers using the Reason for Change feature should evaluate whether their Reason for Change configuration is impacted, and make plans to update their configuration after the release.

Recurrence Check Insights

When Reason for Change is enabled for a field, and a user accepts a field suggestion using Recurrence Check Insights, Vault will now prompt the user to provide a reason for change.

The following screenshots illustrate the user experience when a user accepts one field suggestion, and that field is governed by Reason for Change configuration.

The screenshots below show the user experience when a user accepts all of the suggested field changes and there are multiple fields governed by a Reason for Change configuration.

This feature is automatically enabled in Vaults with the Reason for Change and Recurrence Check Insights features configured.

Action Paths

When Reason for Change is enabled for a Change Action field, and a user edits a Change Action field from an Action Step, Vault will now prompt the user to provide a reason for change.

This feature is automatically enabled in Vaults with the Reason for Change and Action Paths features configured.

Reason for Change Capture Field

This release includes a new constraint that ensures Admins do not make the Reason for Change Capture field required. This field is used by the Reason for Change feature, but it is not displayed to users and therefore cannot be required.

If an Admin attempts to save a Reason for Change configuration, and the selected Reason for Change Capture field is mandatory, Vault displays an error message.

If an Admin already configured the Reason for Change Capture field to be required, Vault will display an error message to the user indicating there is an invalid configuration, when the user attempts to save changes to a record governed by the Reason for Change configuration. As a result, customers should confirm their Reason for Change Capture fields are not required.

This feature is automatically enabled in Vaults with the Reason for Change feature configured.

Reason for Change: Support for Word Formatted OutputsConfiguration25R3.2

This feature introduces the ability to include Reason for Change information about a record in the record’s formatted output file. For example, the following Deviation has two Reason for Change records.

The corresponding section of the Deviation record’s formatted output file displays the details of the two Reason for Change records.

Including Reason for Change details in a record’s formatted output requires configuration of a Word Formatted Output template. The screenshot below shows the syntax of the command that must be added to a Word Formatted Output template to include Reason for Change details.

The statement shown in the screenshot above is provided below to make it easy to copy and paste into your own Word Formatted Output templates.

${GetContent(com.veeva.vault.app.quality.qms.reasonforchange.contentgenerator.ReasonForChangeContentGenerator)}

This feature is enabled through configuration. It only applies to Vaults with the Reason for Change feature configured.

Download as PDF: Export Audit Trail Entries Associated to Reason for Change RecordsAuto-on25R3.2

The Download as PDF (print record) experience for Reason for Change records has been enhanced to include Audit Trail information for those changes. In addition to the object metadata captured directly on Reason for Change object records, the generated PDF will now include a table displaying the key information that was changed on the quality process record in a new Audit Trail section.

This feature is automatically enabled for all Vaults, and the new section will be present when a Reason for Change record is next downloaded.

Proposed APQR-to-APQR Field InheritanceAuto-on25R3.2

In 25R2, the APQR Programs feature was introduced. As part of the 25R2 release, Proposed APQRs leveraged the Management Review Template to populate field-level data into APQR records. With this enhancement, when using APQR Programs and Proposed APQRs, Vault now evaluates additional field-level data during APQR record generation. Specifically, when an APQR is created from a Proposed APQR, Vault transfers the field values for Description, Product, Owning Facility, and Country from the Proposed APQR to the APQR record if the corresponding fields in the Management Review Template are blank. This ensures that APQR records are consistently populated with the most complete and relevant information available.

5 Whys User Interface EnhancementsAuto-on25R3.2

With this release, the 5 Whys user interface has been enhanced to more clearly indicate that Completed root cause analysis flows are in a steady state and locked. Prior to this release, in some scenarios a user may have seen a +Why or Edit gesture on a completed Root Cause Analysis Item even though these gestures did not allow users to change root cause analysis information in the Completed state. Additionally, these gestures will no longer display to users if security configurations indicate that Root Cause Analysis records should not be created, deleted or edited. This change is automatically enabled in Vaults leveraging 5 Whys. You can learn more about working with Root Cause Analysis and 5 Whys in Vault Help.

Quality-Safety User Exception Item EnhancementAuto-on25R3.2

For organizations leveraging the Quality-Safety Connection, the User Exception Item message in Quality Vaults has been enhanced to always include the Case ID from the originating Safety Vault if any of the following errors are encountered:

• There is a failure prior to querying the first integration rule.
• There is a failure in any of the integration rules.
• There is a failure while saving records.

These IDs enable Admins to trace connection configuration challenges back to the originating Cases within the Safety Vault more easily for connected Quality and Safety Vaults.

Related Event Section: Display Gestures based on User PermissionsAuto-on25R3.2

With this release, the Related Events application section now more clearly reflects user permissions. Prior to this release, the Create, Delete and Edit gestures on a record’s Related Events section were displayed to users who did not actually have the permissions to execute them. With this release, these actions will be context aware, displaying only to users who have the appropriate permissions to execute those actions. This change is automatically enabled for all Vaults leveraging the Related Events application section.

Quality Team Section: Display Minimum & Maximum User RequirementsAuto-on25R3.2

This release makes it easier to know the requirements when assigning users to a Quality Team from the Quality Team section on a record. Each role now displays the minimum and maximum number of users that must be assigned to that role clearly in the Vault UI.

This feature is automatically enabled. You can learn more about working with Quality Teams in Vault Help.

Email Body Section: Display Warning Message when Content Exceeds Character LimitAuto-on25R3.2

Organizations can send emails to the QMS application to automate the creation of Supplier Change Notification, Complaint, and Complaint Intake records. Admins can configure these objects to display the content of the email within a record’s details page. Previously, when an incoming email exceeded the display limit of 32,000 characters, the email content on the record’s details page was silently truncated, potentially causing users to miss important information.

In order to ensure users never miss critical information, when the email exceeds 32,000 characters, Vault now displays a warning message on the details page instead of truncating the email content.

When this warning is displayed, the full email is available to view within the record’s Attachments section.

This feature also extends to downloaded PDF copies of a record generated using the Download as PDF menu option, as shown below.

Vault will now display a warning message inside the downloaded PDF instead of truncating the email content.

This feature is automatically enabled in Vaults that are configured to create records from emails.

Batch Release, QMS

Prevent Actions from Copying Roll-Up FieldsAuto-on25R3.2

This release introduces some data safety controls into various QMS and Batch Release application functions that copy records, such that records created from existing records (for instance, when users copy an APQR) will not propagate erroneous roll-up field data into non-roll-up fields on the newly created target record.

Prior to this release, with certain configurations, roll-up field data was copied from a roll-up field on the source record, into an appropriate data-type field with the same name as that source roll-up field on the target record when users ran certain QMS and Batch Release actions. That will no longer occur as of this release. The impacted actions are:

• APQR Program: Create APQR Records (QMS)
• Create Record from Template: APQR, Audit Program, Change Action Templates, Impact Assessment Templates (QMS)
• Capture Assessment History (QMS)
• Create Batch/Lot Disposition from Record (Batch Release)
• Review Plan (Batch Release)

Batch Release

Closing Items with Action TriggersAuto-on25R3.2

With this release, Action Triggers are replacing Application Triggers so Admins can configure when to close Batch Disposition Items based on related record criteria.

Share DispositionConfiguration25R3.2

This feature allows users to share documents related to a Disposition with any users, including VeevaID users with the Batch Release: Batch Disposition Share permission set. When a Disposition is shared, the recipient can view and download selected documents from the Batch Disposition Share App Page.

Surveillance

VPS: eMDR Follow-up Reporting EnhancementAuto-on25R3.2

Vault Product Surveillance’s submissions of Follow-up Report data are now more intelligent, highlighting changed information when preparing Follow-up Reports, and sending only information required and changed since the last successful XML generation and submission. Helpful icons will appear next to both sections and fields which have had data changes since the latest submission of the AER.

Previously, it was challenging for organizations to keep track of which metadata has changed in a follow-up report scenario, so each submission of an AER to a health authority was a full submission with all metadata included - both information that has changed since the last submission of that report, as well as information that has not.

Now, when generating the XML for a submittable AER, Vault will populate the Previous Report field on AER to track data changes over time. In instances where a Follow-up Report XML is generated, Vault will automatically highlight those changed fields, providing key UI indicators on fields with values that have changed since the last submission. This support covers both field values on the AER directly, and field value changes on the underlying related records of the AER. To illustrate, in the screen below, eight fields were changed on the underlying Manufacturer’s Site Contact Information record, and you can view those changes quickly from the AER pages.

Change information is also presented in hovercards, and when dates or times are included in the changed content, they will be displayed rendered in the user’s local timezone for easy interpretation. Lastly, subsequent follow-up submissions will include only the changed information as well as any key metadata required for the Health Authority to consider the submission complete.

After enablement, this feature will apply field value delta tracking to all AERs once they next have the Generate XML action run upon them. Data at rest will be unaffected by enablement of the feature.

In addition to the previous version awareness support, eMDR AERs have had section H10’s UI updated for better clarity & interaction when populating and reviewing the data, with more clear controls for adding relationships and inline editing.

This feature is available for use with this release, and requires some configuration. Learn more about working with Adverse Events.

VPS: EU MIR EnhancementsAuto-on25R3.2

In accordance with the change to EU MIR format 7.3.1, Vault Product Surveillance can now generate 7.3.1 complaint AERs for submission. The changes are only to the generated XML & AERs, and fully restructure the generated AERs to be compliant with the new format. We have also updated the Vault EU MIR Adverse Event Report UI to reflect the new format.

To give organizations more control over adopting the new format in advance of the EU MIR recommendations, existing Product Surveillance configurations are not automatically updated to the new formats with this release. Some minor configuration updates are required to change over to this format version. VPS customers are strongly encouraged to make the change during the 25R3 timeframe, as Veeva will be mandating the use of this format across all VPS customers in 26R1.

In addition to the EU MIR 7.3.1 enhancements, Product Marketed Countries in section 2.5, XML & PDF generation shall no longer include INVALID_COUNTRY as an entry for non-accepted country values. These invalid values, should they be present in the AER, will be omitted from the generated XML & PDF entirely. This also applies to section 3.4, and all similar Country captured data in the AER.

QualityDocs

Support Up to 5 External Collaborators for Document External CollaborationAuto-on25R3.2

This feature increases the number of External Collaborators who can participate in a single External Collaboration Review or Approval workflow from 3 to 5. Vault will display an error if a user attempts to create or save a document with more than 5 persons selected in the External Collaborator(s) document field.

Training

Wave-Based Curriculum PrerequisitesConfiguration25R3.2

This feature extends the existing Curriculum Prerequisites feature by allowing Training Admins to configure rules where Vault unlocks a Curriculum after a specific duration of time, rather than only after completion of another curriculum. This enables staggered, time-phased training delivery so organizations can pace a Learner’s onboarding or certification journey.

This feature’s key capabilities include:

• A new prerequisite rule type, Time-Based Prerequisite.
• Unlocking a curriculum based on the number of days or months after the default Learner Initial Activation Date.
• UI Indicators on the Learner Homepage showing locked curricula and assignments as per wave-based prerequisite.

Quiz: Support Multiple Choice Dropdown QuestionsConfiguration25R3.2

This feature adds a new dropdown-style answer format for multiple-choice quiz questions. This reduces visual clutter for Training Admins creating quizzes and provides Learners with a cleaner, more space-efficient interaction model. Learners can select answers via dropdown and see correct answers after completing the quiz.

Training Change Request: Create Matrix RecordsAuto-on25R3.2

Initially released in 25R3, Training Change Request now supports creating new Training Requirements, Curricula, and Learner Roles. In addition, the feature now also supports the use of the Base Learner Role (base__v) and Base Learner Role-Person (base__v) object types.

Previously, Training Change Request supported only the addition, removal, or retirement of existing matrix records. Now, new records can be created as well. As with the initial release, Vault automatically creates requested records on the Training Change Implementation Date.

Below describes how to process requests from a user with fewer permissions or a user with elevated permissions. A user with minimal permissions (a non-Training Admin) can request creation of a new record by entering a text description and some minimal metadata. This means an organization does not have to grant additional permissions for any user to make a change request, as Training Admins have the opportunity to fill in any required data as a part of their review.

• When creating a change item to create a new record, a user with elevated permissions is prompted to populate metadata and additional details for the object, and upon saving, the Matrix Change Item is marked Ready to Implement.
• If the user making the request does not have elevated permissions, they are prompted to provide a description of the change in a plain text description. Then, upon saving, the Matrix Change Item is marked Incomplete. From here, the Training Admin completes the process based on the text description provided by the requestor.

Training Focus TimeAdmin Checkbox25R3.2

This feature tracks how long a Learner spends on a given Vault Document Training Assignment. While it is not an indicator of how long it takes to complete a training (as indicated by a requirement’s Estimated Time to Complete (Minutes) field), it tracks how long the Learner was focused on the assignment page. Each time the Learner is focused, Vault adds the number of seconds to the assignment’s Task Page Focus Seconds field.

Customers can now use tracking data to draw their own conclusions related to training effectiveness or efficiency.

• The “timer” starts when the Learner opens the document’s assignment task page.
• When the browser identifies that the Learner has “clicked away,” the timer stops. When focus is back on the page, the timer starts again where it left off.
• For multiple browser tabs, each has its own timer.
• When the Learner closes the browser without completing the Training Assignment, Vault adds the time (in seconds) to the focus time. When the Learner opens the assignment again and completes it, Vault adds these seconds to the Focus Time.
• Admins can view focus time via the Task Page Focus Seconds field on the Training Assignment record, or via a custom report.

LIMS

Trend ChartsConfiguration25R3.2

This feature introduces embedded statistical process control charts in Veeva LIMS. From a Spec Execution detail page, users can now use control charts to compare the batch’s results against previous batch results. The charts identify and highlight the results that are out-of-control (OOC) and out-of-trend (OOT) using Nelson and Westgard Rules.

This feature supports the following chart types: X-bar, R Chart, S Chart, I and MR Chart.

Design Data Administrators can pre-define the type of analysis and chart to use for each test result type. The definition also supports version control and change analysis, and considers dependencies on their related Product Test and Spec Data definitions.

Allow Documents To Be Selected For Sample Result Entry Test DefinitionsConfiguration25R3.2

For Sample Results Entry (SRE) Test Definitions, users can select and display documents during Test Definition build. This allows Admins to reference procedures while building and updating an SRE Test Definition.

Design Data Builder: Save Last Page User Was OnAuto-on25R3.2

With this update, when a user exits and then reenters Design Data Builder, Vault automatically returns them to their last accessed spot.

View Version History From Design Data BuilderAuto-on25R3.2

With this update, from Test Definition or Spec Data Builder, an Admin can view all versions of that design data record.

Updated UI for Result DefinitionAuto-on25R3.2

With this release, the following field types now have icons next to them:

• Picklists:
  • (Result) Data Entry Method
  • (Criteria) Indication
  • (Result) Precision and Precision Type
• Object Reference:
  • (Inputs) Expected Amount + Units
  • Mode of Entry
• Other
  • (Result) Object Types

Mode Of Entry Can Be UpdatedAuto-on25R3.2

With this feature, users can now change a Test Definition’s Mode of Entry. If the Mode of Entry is Sample Result Entry, it can always be changed to Guided Test Execution. If the Mode of Entry is Guided Test Execution, it can be changed to Sample Result Entry if it meets all of the following conditions:

• No attached documents
• No Inputs
• No Operational Results
• Only one Step
• Check integrations, SLRs, Cross Test, Aggregate
• No Variations with Mode of Entry of Guided Test Execution

Auto-Scroll to New Result/Input RecordAuto-on25R3.2

When there is a long list of Inputs or Results, when a user creates a new record, Vault automatically scrolls to the record and focuses on the Name field.

Operational Results Renamed to Method Parameters in Test Definition BuilderAuto-on25R3.2

With this update, we have renamed Operational Results to Method Parameters in the Test Definition Builder.

Test Definition Builder: General UI UpdatesAuto-on25R3.2

With this update, we have made the following changes to the Test Definition Builder UI:

• Placeholder text is now displayed for field entries
• Tooltips appear when hovering over fields
• Not Applicable is hidden for locked Test Definitions

Updates to Calculated Method Parameter ResultsAuto-on25R3.2

With this feature, we’ve made the following changes to Calculated Method Parameter Results:

• For Operational Results, for Calculated Result, for Basic Variables, the Target Result now filters out
• For Operational Results, for Calculated Result, the Cross Test Variable variable type is not shown
• For Operational Results, for Calculated Result, the Aggregate Variable variable type is not shown
• For Operational Results, for Calculated Result, Material constant types for Constant Variable type are not shown

Inline Field ValidationAuto-on25R3.2

Before saving, Veeva LIMS now shows inline errors if a required field is left blank or (for text and number field types) if the field value does not meet minimum or maximum requirements.

Test Definition Builder: Test MethodAuto-on25R3.2

With this release, the Test Method text field is available in the Test Definition Builder.

Test Definition Builder: Respect Default ValuesAuto-on25R3.2

The Test Definition Builder now respects default value configuration at the field level or object type field level.

Test Definition Builder: Keyboard Shortcuts & NavigationAuto-on25R3.2

Keyboard shortcuts can be used to perform certain actions (create, edit, save, delete) on Test Definition Builder. In addition, keyboard navigation (TAB) can be used to navigate across the screen.

Test Definition/Spec Data Builder: SearchAuto-on25R3.2

Users are now able to search within the Test Definition and Spec Data Builders.

Spec Data Builder: Edit Spec Data CriteriaAuto-on25R3.2

Users can edit Spec Data Criteria without having to go through the Assign Tests dialog.

Spec Data Builder: Respect Default ValuesAuto-on25R3.2

The Spec Data Builder now respects default value configuration at the field level or object type field level.

Spec Data Builder: Sample Plan Can Be Edited If BlankAuto-on25R3.2

With this update, users can edit blank Sample Plans within the Spec Data Builder.

Spec Data Builder: Spec Data Defaulted for Criteria SetAuto-on25R3.2

In the Spec Data Builder, when creating a new Spec Data Criteria Set, the Spec Data field is now populated and read-only.

Spec Data Builder: General UI UpdatesAuto-on25R3.2

With this update, we have made the following changes to the Spec Data Builder UI:

• The Lab Samples Collected terminology has been updated to Lab Samples Defined.
• Text underneath circles has been updated to Click a sample or group of samples to define actions.
• The Order tab for Assign Test does not display if only one SRE Test Definition is selected.

Spec Data Builder: Export List of Unsupported SetupAuto-on25R3.2

When opening the Spec Data Builder, if the configuration is unsupported, users can export the configuration list to XLSX format.

Spec Data & Test Definition Builder: Keyboard Navigation & Shortcut SupportAuto-on25R3.2

The Spec Data and Test Definition Builders now support keyboard navigation and shortcuts.

Test Definition Compare: Hide Fields Not Applicable to Object TypeAuto-on25R3.2

This feature enhances Test Definition Compare by hiding fields that are not applicable to the Object Type being viewed.

Stability Summary Report: Grouping Logic for Multiple Test Definition VersionsAuto-on25R3.2

This feature updates the Stability Summary Report to group results from Test Definitions with the same Trace ID into a single row, splitting rows only when the Criteria Description differs. For multiple versions, it uses the most recent version’s Test Definition name, Result Definition name, and Criteria Description.

Spec Data Builder: Not Applicable Behavior UpdateAuto-on25R3.2

Checking the Not Applicable box now decrements the denominator for Lab Samples Defined.

Spec Data/Test Definition Builder: Enter Key Support 25R3.2

All dialogs on the Spec Data builder perform the primary action on enter. This includes the following dialogs:

• Delete confirmation dialogs for all Sample Action cards, Not Applicable, and Clear buttons
• Dirty warning dialogs when canceling create/edit of Sample Action cards, clicking Next/Back buttons, or clicking Sample Definitions on the sidebar

Test Definition Builder: Default Basic Variable NameAuto-on25R3.2

When a Variable is created, LIMS defaults the Variable Name to the Result Name. Users may further edit Variable Name.

Test Definition Builder: For Sample Result Entry Variations, Only Allow Valid SetupAuto-on25R3.2

With this update, the following cannot be configured on a Test Definition Variation of Variation type Sample Results Entry:

• Integration Results
• Inputs
• Any results on > 1 unique step
• Any cross test or aggregate variables

Test Definition Builder: Including Results for Sample Result Entry VariationsAuto-on25R3.2

For Sample Results Entry Test Definition Variations, Admins cannot select results that are not allowed to be included.

Test Definition Builder: For Variation Result Inclusion, Auto-Select Dependent ResultsAuto-on25R3.2

When a result is selected for inclusion in a Test Definition Variation, dependent results will now be automatically selected. For example, if a calculated result is selected for inclusion in the Variation, the results that feed into the calculated result are now automatically selected.

Sample Result Entry Display Sample NameAuto-on25R3.2

This feature adds the display of the Sample Name when selecting samples, and when entering results for samples, making it easier to identify the samples when selecting and entering results.

Stability Study CSV ExportAuto-on25R3.2

This feature updates the Stability Study CSV export to output result values and units in separate columns, making it easier for downstream tools to sort, filter, and analyze data without manually separating units from values.

Set Lab Study Owner on Creation from Lab Study DesignAuto-on25R3.2

This feature sets the Owner of the Lab Study to the user who generates it from a study design.

Validation Management

Test Step Change: Full Attachment NamesAuto-on25R3.2

With this release, Vault will capture the full attachment names in the original and new value fields on the Test Step Change records when completing the Test Step Change process on an executed test step’s attachments.

Previously, the attachment names were truncated at 20 characters in the original and new value fields. While the full names of current attachments (as seen on the test step) and removed attachments (captured as attachments on the test step change record) were available, this could lead to confusion if multiple attachments had the same or similar file names.

With this feature, the full file names of the features will now be captured in the original and new fields, removing any uncertainty around what files were added or removed from the test step. This feature will be auto-on.

Application Interface Side Panel ImprovementsAuto-on25R3.2

With this release Validation Management interfaces (Author Test, Review Test, Execute Test, etc) will introduce the ability to collapse and expand the side panel, where step navigation, requirement burndown, and comments are shown. This allows authors, executors, and reviewers to focus specifically on the test steps by increasing the space available for steps. The side panel can be collapsed through the collapse button, and expanded through the expand button or by clicking on an existing tab (such as step navigation). This feature also includes further refinement for the width of the side panel across different browser resolutions. This feature will be auto-on.

Validation Team Warning ControlsConfiguration25R3.2

With this release, customers will be able to decide when Validation Team Assignment (VTA) based user fields (e.g. Author, Executor, Activity Owner, etc.) are verified by object and state.

Previously, whenever a record was updated (directly through editing, or indirectly through a state change or related record state change or update) and the user selected no longer had an active VTA, Vault would provide an error indicating that the user was not valid. This feature will allow administrators to determine when these VTA-related user fields no longer need to be checked through a new Admin configuration under Quality Configurations. For example, an Admin could add a Validation Team Warning Control record which identifies that the Author should not be checked for test scripts which are in states which are used after Pre-Approval (such as In Execution, In Post-Approval, Post-Approved, or Cancelled). This provides more flexibility to support different lifecycle and workflow configurations, while still ensuring that only users with active VTAs are selected in key user fields which are leveraged for roles and workflows.

This feature is enabled through configuration. An Admin will need to add Validation Team Warning Control records to identify for which objects and states the existing warnings should be disabled.

Regulatory

Features in the Veeva Connections section also affect the Regulatory application family.

RIM Publishing

South Korea Validation UpdatesConfiguration25R3.2

What’s New?

Veeva Publishing now supports the latest updates to South Korea’s Ministry of Food and Drug Safety (MFDS) Validation Criteria v1.0. The most recent version introduced the implementation of five new rules (1.9, 3.8, 3.9, 3.10) and updates to two existing rules (1.15) as detailed here:

• 4 new rules implemented (1.9, 3.8, 3.9, 3.10):
  • 1.9 validates the relative path of the Published Output Location
  • 3.8 checks the application submission file
  • 3.9 checks if there is one or more applications being submitted
  • 3.10 checks the existence and validity of the application file
• Updates to Rule 1.15 which checks the file extensions

Key Benefits

The inclusion of these updates ensures that Submissions Publishing remains fully compliant with the latest regulatory standards for customers working with South Korean submissions.

Configuration of Validation Criteria can be provided to customers via VPK to aid in deployment, provided in the Veeva Product Support Portal.

eCTD 4.0 UpdatesAuto-on25R3.2

What’s New?

Improved Japan Cover Letter Handling

Vault now supports the XML Element Name = unreferenced-files when publishing eCTD 4.0 submissions. The Japan eCTD 4.0 Content Plan will include a new Content Plan Item in Module 1 for the Cover Letter (Published Output Location = m1/jp/cover.pdf). These ‘unreferenced-files’ will not be included in the submissionunit XML upon publishing, but will be included in an unreferenced files section under Module 1 in the Submissions Archive Viewer.

For Example, unreferenced cover letters would have the following:

• CP Name: ${submission__v.xml_submission_id__v} Cover Letter
• CP Title (xml_title__v): ${submissionv.xml_submission_id__v} Cover Letter
• XML Element Name: unreferenced-files
• CPI Name (as desired)
• Published Output Location (xml_xlinkhref__v): m1/jp/cover.pdf

Automated Sequence ID Updates

Automated Sequence ID generation for eCTD 4.0 submissions will now look at previous eCTD 3.2 sequences and increment the next sequence by 1 (dropping any leading zeros). For example, the last submission in an application that was submitted with eCTD 3.2 was ‘0045’. When creating the first eCTD 4.0 submission for the same application, the automatically generated Sequence ID will be set to ‘46’ (instead of 0045). In an eCTD 4.0 application, the automatically generated Sequence ID will be set to ‘1’ if there are no previous sequences.

Table of Contents Generation for Japan eCTD 4.0

Publishing now supports the creation of a TOC document with the heading jp_m1.1 for Japan eCTD 4.0. Vault now allows for a Content Plan Item Node Type (node_type__v) value of table_of_contents__v for a Context of Use, and will also generate a Priority Number. Vault will also include a checksum (sha-256) for the TOC on the submissionunit.xml. The TOC will be automatically generated and handled as a replace operation if a previous TOC exists.

Key Benefits

These changes support ongoing regulatory compliance efforts, as well as usability and automation improvements to make eCTD 4.0 publishing more efficient, and to offer additional functionality specific to Japan eCTD 4.0 publishing.

Additional Considerations

These enhancements build upon the previous configuration and adoption of eCTD 4.0 data model updates and configuration changes.

RIM Publishing, RIM Submissions Archive

Streamlined Import with Automated eCTD Data PopulationAdmin Checkbox25R3.2

This enhancement improves the Submissions Archive import experience by streamlining the Submission record data entry. For eCTD submissions, the XML will serve as the source of truth for any data discrepancies between data previously entered in Vault and the incoming submission’s XML values. Additionally, the Sequence ID (xml_submission_id__v) field will be protected from editing on imported or finalized published submissions.

What’s New?

Submissions Archive Import User Interface For all imports via the UI, users will see a new dialog box that includes Dossier Format and Actual Submission Date fields. Users will be prompted to complete these mandatory fields if they are not populated. This prevents downstream viewing errors due to missing data, and prevents users from having to return to the Submission record for manual data entry if these fields were not populated.

eCTD Import Data Consistency Upon import of eCTD sequences, Vault will automatically read the incoming XML file and populate or overwrite missing or discrepant key Vault record fields. As the XML file represents what was submitted to the Health Authority, its values will be regarded as the source of truth in the event of any discrepancies with data values entered into Vault RIM. In particular, if Vault will check the following values:

• Application > Application UUID
• Submission > Sequence ID
• Submission > Submission UUID
• Submission > Submission Unit UUID

Should a discrepancy be corrected by Vault, the user will be notified of the system action, including the previous and new values. The system action and on-behalf-of User will be included in the audit trail for traceability.

Sequence ID Lock
Upon successful submission imports (e.g., Dossier Status = Import Successful), the Sequence ID field will be locked from edits. This prevents users from intentionally or accidentally changing a Sequence ID that has been used in a finalized submission. The Sequence ID field will also be locked from editing if a submission published with Submissions Publishing reaches its finalized state (e.g., Publishing Inactive, Transmission In Progress). This automatic action protects the archived source file path and ensures the data integrity of dispatched submissions.

Invalid XML Handling
Upon import of an eCTD submission with an invalid, yet Health Authority-accepted XML, users will be prompted to complete the missing XML-related field on the RIM Submission record. This will allow the system to complete the import job and bypass the missing XML element.

Key Benefits
These enhancements reduce the manual effort of Submissions Archive importers by streamlining their data entry steps, and by identifying and auto-correcting data entry errors that do not match those in the submitted XML. These enhancements preserve the data that was submitted to the Health Authority, and ensure the same submitted data is reflected in Vault RIM object records.

For example, a Submission record Sequence ID was entered as “9009” and the imported XML file value equals “0009.” Vault will update the Submission record value to “0009” and notify the import user of the discrepancy. The XML was submitted to the Health Authority and is therefore considered the source of truth. The audit trail will include the system-managed action to change the RIM Submission record value. No changes will be made to the XML file, nor to any files included in the imported dossier.

Additional Considerations

• The new import modal will appear for every Import action, regardless of incoming Dossier Format (e.g., eCTD, NeeS, Paper). The Import-initiating user will require Edit permission to specify the Dossier Format if it is not defined on the Submission record.
• XML auto-population will run for all supported eCTD versions as defined in the Veeva Help documentation.
• The Sequence ID lock will apply to all Submission records (existing and all new imports) with a Dossier Status = “Import Successful”, and to Submission records that only have the Submissions Archive Status field populated with “IMPORT_SUCCEEDED” (Dossier Status = empty)

RIM Registrations

Update Local Regulatory Information: Limit to ActivitiesAuto-on25R3.2

What’s New?

The Update Local Regulatory Information action now includes a Define Activities step in its guided flow. This new step appears after the Define Relationships step and allows you to limit the scope of the update to specific Activities.

• You can now choose to scope the update down to select Activities.
• If you choose to limit the scope, you will be prompted to select one or more Activities.
• Once the action is complete, Vault limits the creation or updating of details (joins) to the selected Activities and their related Regulatory Objectives and Submissions.

The core validation logic for determining if an update is necessary remains unchanged.

Key Benefits

This feature helps maintain data integrity by preventing the creation of irrelevant data. By limiting the activities considered, you ensure that creation or updating of regulatory details is only performed for the records you specify.

Additional Considerations

• Today, without this feature, Vault considers all Activities, Submissions, and Regulatory Objectives associated with the Event.
• The validation logic will continue to determine if an update is necessary.

Support for Defaulting Event in Impact Assessment Report PromptAuto-on25R3.2

What’s New?

Impact Assessment Reports configured with an Activity > Event prompt and the “in” operator will now automatically default the Event in the Impact Assessment Report Options dialog.

Key Benefits

Allows users to skip entering the Activity > Event prompt, limiting overall clicks to get to the results.

Additional Considerations

Only the “in” filter prompt will prepopulate for Event. Vault does not prepopulate for the “equals” or “is not equal to” operators.

Create Event Details Support for Event Product & Event Indication FieldsAuto-on25R3.2

What’s New?

The Create & Manage Event Details (CMED) wizard has been updated to improve the handling of related Event fields: Event Product (on Event Inactive Ingredient) and Event Indication (on Event Clinical Study). These fields are now appropriately populated based on whether the detail is used for Registrations or Content Planning.

Event Inactive Ingredient Records

When CMED creates or generates Event Inactive Ingredient records:

• If Use for Content Planning = No, the Event Product field on the created Event Inactive Ingredient record will not be populated.
• If Use for Content Planning = Yes, an Event Inactive Ingredient record is created by that change where Use for Content Planning = Yes, and one of the following is true:
  • The Inactive Ingredient is related to the Product Variant on the Event Product via a Product Variant-Inactive Ingredient join.
  • The Inactive Ingredient is related to the Complex Product on the Event Product via a Product Variant-Inactive Ingredient join between the Inactive Ingredient and one of the Complex Product’s components.
  • The Product on the Event Product is not complex, and Product Variant is left blank.

Event Clinical Study Records

When CMED creates or generates Event Clinical Study records:

• If Use for Content Planning = No, the Event Indication field is not populated on the created Event Clinical Study record.
• If Use for Content Planning = Yes, the Event Indication field is populated on the created Event Clinical Study record with the first Event Indication record created by that change where Use for Content Planning = Yes.

Key Benefits

This update ensures that Event relationship fields are accurately and automatically populated based on the intended use of the Event details (Registrations or Content Planning).

Update to Select All within Create Related Records WizardAuto-on25R3.2

The Create Related Records wizard has been updated to support the selection and deselection of records across all pages on the detail selection grids in the Define Relationships step.

• The existing checkbox in the grid’s column header is replaced with a new Select All / Unselect All button above the grid.
• When Select All is selected, records across all pages for the object are selected.
• When Unselect All is selected, records across all pages for the object are deselected.

Key Benefits

The previous functionality only allowed the selection or deselection of records within a single page of the detail selection grid. Users can now efficiently select or deselect all records across every page in the detail selection grids, eliminating the need to click across multiple pages.

Updates to Styling of Registrations Wizards & PagesAuto-on25R3.2

What’s New?

The styling has been updated on several Registrations wizards and pages. The update ensures a consistent look and feel across all Registrations wizards and pages by aligning the page header, navigation pane, and wizard/page descriptions.

The following wizards and pages have been updated to use the consistent styling:

• Split Activity
• Update Local Regulatory Information
• Create & Manage Event Details (CMED)
• Preview pages for Create Related Records & CMED
• UDI viewer
• IDMP viewer
• Bulk generate, export, and submit FHIR messages.

Previously, Registrations Wizards and pages used differing styling patterns.

Styling Patterns 1 and 2 are shown below. All Wizards and Pages will now be updated to follow styling Pattern 2.

Styling Pattern 1 (Update Local Regulatory Information as example):

Styling Pattern 2 (Create Related Records as example):

Key Benefits

This update provides a more consistent and streamlined look across the application by ensuring all Registrations wizards and pages use a single styling pattern.

Additional Considerations

This update affects the styling only and does not impact the functionality of the wizards or pages.

RIM Submissions, RIM Submissions Archive

Create GCP from AD - Clinical/Nonclinical Study & Indication SupportConfiguration25R3.2

The initial functionality to create a GCP from Active Dossier only supported relationship matching and document mapping for Product, Active Substance, and Inactive Ingredient repeating section records. Documents in Clinical Study, Nonclinical Study, and Indication repeating sections were previously logged in the warning file. The capability to match relationships and map documents is now extended to support documents in repeating sections for Clinical Study, Nonclinical Study, and Indication records. This enables users to create a new Global Content Plan as a Baseline from a reference Application that includes Module 4 and/or Module 5 documents within these repeating sections.

Active Dossier Replaced StatusAuto-on25R3.2

A new Replaced status has been introduced for Active Dossier Item Details. This status will now explicitly track document versions that have been superseded before reaching the Current status.

Key Change: These superseded documents were previously represented with a blank or empty Active Dossier Status. They will now clearly display Replaced.

Impact: This change enhances clarity and provides clearer traceability without altering the existing criteria for determining which document versions are superseded.

Scenarios Covered

The Replaced status is applied in scenarios where the status was previously blank/empty:

• Multiple Versions Submitted: When multiple document versions are submitted across different Submissions for the same Regulatory Objective:
  • The earlier versions are now moved to Replaced.
  • Only the latest version moves to Pending Current (behavior remains unchanged).
• GCP Dispatch: If later document versions are dispatched from a Global Content Plan (GCP) and their related Active Dossier records are created with a status Pending Current those earlier versions that have a status of Pending Current are now moved to Replaced.
• GCP Subsequent Dispatch: When document versions are replaced or removed from the SCP during subsequent dispatches of the GCP, these records are set to Replaced.

Viewer & Editor Support

The new Replaced status is fully supported in the Active Dossier Viewer and Editor:

• Viewing: Available in the AD Viewer (both country overview & item detail layouts).
  • Icon: Represented by the far shuffle icon .
  • Hover Text: Additional hover text/alt-text has been added to the status bubble for a short description.
• Filtering: The new status is available for filtering in the AD Viewer.
• Editing: The new status is available for editing in the AD Editor.

Safety

For the latest central dictionary updates for your Safety Vault, see Safety Central Dictionary Updates.

Several features listed in the Veeva Connections section also affect the Safety application family.

Document Follow-Up QuestionnairesConfiguration25R3.2

This feature extends the ease and usability of online follow-up questionnaires rule setup to every follow-up questionnaire document template in your Vault Library. This allows users to review and approve generated questionnaire content prior to offline or email distribution, supporting accuracy and consistency. This enhancement leverages automated email tracking and follow-up attempts, matching what is already available for scheduled email questionnaires for case reporters. Also, Admins can customize email notification contents for email correspondence methods to match the language of the Case Reporter, making communication clearer and more effective, and can incorporate custom tokens, making messages more personalized and dynamic.

Study AliasesConfiguration25R3.2

To address manual time spent reconciling external study numbers with those in your Study library, Veeva Safety now allows Admins to configure Study Number Aliases for automated Study matching for structured intake sources. This enhancement is particularly useful for customers with co-sponsored studies who commonly receive reports containing the partner’s study number. Previously, such reports resulted in manual effort during intake, as Vault could not automatically reconcile the external study number with the internal one. By allowing Admins to map aliases, Vault can now match incoming reports to the correct study. This feature reduces manual effort, improves intake efficiency, and enables automated Case promotion for structured sources being sent by trusted partners.

Duplicate Detection Results Log & Usability ImprovementsAuto-on25R3.2

With this release, Veeva Safety introduces more tracking, usability, and navigation to the Potential Matches page for duplicate detection.

Tracking

• Results Log: When duplicate detection returns at least one search result, Vault now creates a CSV log of all potential matches and attaches it to the applicable Inbox Item and Case.

Usability Improvements

• Loading Indicator: During duplicate detection after users run the Promote to Case action from an Inbox Item or the Duplicate Search on Case action from a Case, Vault now displays a page to indicate clearly that potential matches are loading.
• Indication Banner: When users run the Create New Case, Compare Details, or Mark as Duplicate actions on the enhanced Potential Matches page, Vault now displays a banner to indicate clearly that the action is running.

Enhanced Navigation

• Improved Breadcrumb Functionality: When clicking the breadcrumb trail on the Inbox Item to Case Compare page to return to the enhanced Potential Matches page, Vault now returns users to the previously selected matching record. Prior to this release, navigating back via the breadcrumb trail always returned users to the first record in the list, regardless of which record they last viewed.

This feature improves efficiency, usability, and auditing capabilities.

This feature is Auto-on in Vaults configured for the enhanced Potential Matches page. Other Vaults require configuration.

Duplicate Detection Subject Matching for Clinical Trial CasesAuto-on25R3.2

To accelerate follow up and duplicate evaluation for clinical trial study Cases, the Potential Matches page now includes a Subject Matches section to emphasize and organize Inbox Items and Cases with a Study Type of Clinical Trial. Appearing after ID Matches, Subject Match search ranks and lists matches using the following criteria:

1. EDC subject information (for records generated by the Safety-EDC Connection)
2. Study number and investigational MRN
3. Study number and patient initials

By applying precise subject matching criteria, this enhancement significantly reduces the risk of missing duplicate clinical trial reports, improving data integrity. 

This feature is Auto-on in Vaults configured for the enhanced Potential Matches page. Other Vaults require configuration.

Follow-up Case Compare: Always Promote Non-Displayed DataAuto-on25R3.2

This feature simplifies follow-up case comparison by resolving a known limitation with Case promotion that promotes data only for fields that appear on the Case Compare Followup page. Now, Admins can hide non-essential fields on the page layout, and Case promotion includes the non-displayed data during merge to an in-flight Case or promotion to a follow-up Case.

Product Family Substances Sync ActionAuto-on25R3.2

This feature simplifies Product library maintenance, moving product substance administration to the Product Family level. This release introduces single-click Substance propagation across all Products in a Product Family, reducing Admin labor in Product library maintenance. A new action maps all Substances on a Product Family to every Product within the family group. By automating the relationship of Substances to Products based on Product Family, this feature eliminates manual effort.

Product Use Type for ProductsConfiguration25R3.2

With this release, to ensure search results in the Product Browser are relevant, Veeva Safety now enables you to define the Product Use Type on Products in your Library. Using the Product Use Type field, you can designate Products as Company Use, Study Use, or External Use. 

Company Product Browser Usability ImprovementsAuto-on25R3.2

With this release, Veeva Safety updates the Product Browser, used for fast selection of company products on Inbox Items and Cases, to further streamline and improve efficiency during case processing.

Filtering Improvements

• Dose Strength and Dose Unit fields: The previously combined Dose Strength/Unit field is now two distinct fields: Dose Strength and Dose Unit. Allowing users to filter individually supports more precise product selection.
• Marketing Authorization Start Date: You can now filter based on the Marketing Start Date on Product Registrations.

Usability Improvement

• Expanded Browser View: The Product Browser is now taller and wider. This enhancement reduces the need for scrolling because more rows appear in the browser at once.
• Product Use Type: To return only relevant results, Vault displays only Products with a Product Use Type that is blank or Company Product.

Individual Case Routing Criteria Expression RequirementsAuto-on25R3.2

With this release, when saving an Individual Case Routing Criteria record, Veeva Safety now requires the Expression field to be populated and to start with VS_LET. When the Expression is blank or incorrectly configured, Vault displays a clear error message.

FDA eMDR Automated Site Report NumberingAuto-on25R3.2

With this release, starting January 1, 2026, Veeva Safety generates Site Report Number names using the format {ManufacturerSite.SiteNumber}-{CurrentYear}-{#####}. This feature supports tracking the number of reports per site per year when reporting device cases to the FDA, improving compliance with regulatory requirements when submitting with either the FDA eMDR or FDA MedWatch 3500A form.

PMDA: Multiple Marketing Authorization Holder AutomationAuto-on25R3.2

If you have multiple Market Authorization Holders (MAHs) in Japan, this automation saves time for your data entry team. With this release, Veeva Safety automates support for submitting a single safety case to the PMDA under multiple MAHs. This is useful, for example, when a product containing the same substance is marketed under various entities in Japan. This feature is essential for pharmaceutical companies navigating corporate changes such as mergers or product divestitures, which require submitting reports under multiple MAH entities. To streamline this time-consuming and error-prone process, Vault now considers Registration Holder/Applicant values on Product Registrations to generate Case Product Registrations for each MAH, along with the supporting distinct submissions based on the configured reporting rules. This update reduces the need for manual data entry and supports efficient and compliant regulatory reporting.

Although this feature is Auto-on, some components may require additional configuration.

PMDA MHLW Paper Form: Export Sender's OrganizationAuto-on25R3.2

With this release, Veeva Safety exports the Organization of the User associated with the Sender (User) to Transmissions using PMDA MHLW Paper Forms. Vault populates this value in data elements C.3.4.1–C.3.4.3 in section [1-28] of forms. If a Transmission does not include a Sender (User), Vault maps the Organization on the Case. This update supports compliance with regulatory reporting requirements. 

MHRA MIR (XML)Auto-on25R3.2

With this release, Veeva Safety supports the generation and submission of the MHRA Manufacturer Incident Report (MIR) to the Medicines and Healthcare products Regulatory Agency (MHRA). Vault formats the document as an XML using the schema definitions (XSD) for Great Britain for the Manufacturer’s Online Reporting Environment (MORE) reporting system and conforming to the GB MIR 7.2.1 schema.

Transmission Reason Defaulting for Migrated CasesAdmin Checkbox25R3.2

With this release, Admins can configure their Vault to default the Transmission Reason to Initial when a Submission or Distribution is generated for a Case with no previous Transmissions. This setting applies this behavior even when Vault generates a Transmission for a follow-up to an imported Case with no previous Transmission. This feature streamlines case processing and reduces the risk of error by supporting correct initial reporting for Vaults that migrated previous transmissions into the system.

FDA E2B(R3) Standard Reporting Rule Version 4Configuration25R3.2

With this release Veeva Safety updates the standard FDA ICSR Reporting Rule Set to add Investigational to Investigational reporting scenarios for FDA E2B(R3) cross reporting. This update ensures compliance with regulatory reporting requirements.

Case Approval Due DateConfiguration25R3.2

Cases with regional requirements require additional processing after approval, which can vary greatly by region (for example, Japan, China, Korea) and result in stricter timelines for global case processing teams to reach approval. With this release, Veeva Safety introduces a new Approval Due Date field on Cases. This field represents the internal deadline for Case approval, ensuring that Case Processors are immediately aware of the target date necessary to complete processing ahead of the regulatory submission due date. Admins can configure an Approval Due in Days Safety Rule Parameter in Safety Rules, allowing the Safety Reporting Rules Engine to automatically calculate and populate the Approval Due Date on a Case based on configured regulatory timelines. This automation significantly improves internal compliance and reduces the risk of late regulatory submissions by providing critical visibility into internal processing deadlines.

LATAM E2B(R3) Relabeled to Vigiflow E2B(R3)Auto-on25R3.2

This change communicates that Vault’s E2B(R3) file for submitting through Vigiflow is available for use with all health authorities and partners (for example, TÜFAM Türkiye) that accept submissions through Vigiflow. To clarify this, Veeva Safety is updating the label of the LATAM E2B(R3) document type to Vigiflow E2B(R3). Vault now displays Vigiflow E2B(R3) as the label in both the Document Type and Document Classification fields. This update simply clarifies the report format for users. There are no changes to document export or data mapping. 

Transmission Document Generation StatusConfiguration25R3.2

With this release, Veeva Safety introduces the Transmission Document Status field on the Transmission object, allowing users to track the generation status of transmission documents. This enhances operational visibility and control over document generation, supporting timely submission preparation.

Validation Criteria: Assessments Require Products and Adverse Events (G.k.9.i.1)Auto-on25R3.2

With this release, Veeva Safety introduces additional ICH validation criteria for ICH. G.k.9.i.1 to check for blank Case Product or Case Adverse Event references on Case Assessments. This ensures that the validation of regular Cases and E2B imported Cases remains fully aligned with the latest agency business rules.

Safety Workbench

“Not In” Report FilterAuto-on25R3.2

Veeva Safety Workbench introduces the not in filter operator for reports for Object and Picklist field types. Users can now easily exclude specific Cases, such as those within a Case series, from their ad-hoc reports. This filter operator provides greater flexibility and precision when defining report criteria directly in the UI.

Calendar Date Report FiltersAuto-on25R3.2

With this release, Veeva Safety Workbench enhances reporting flexibility by adding calendar-based filter operators that are relative to the current date, for example, Current Quarter, Previous Month, and Today, for date fields. This eliminates the need for hardcoded SQL to define dynamic date ranges and streamlines the creation of reports for routine signal analysis and quarterly or monthly case review.

Workbench Report StatusAuto-on25R3.2

In 25R3, Veeva Safety Workbench introduced canceling a running Workbench Report. With this release, users can now view the running status on Workbench Reports, for example, whether a run is in progress, was canceled, or resulted in an error. Furthermore, reports can no longer be edited while they are running.

Reusable Excel TemplatesAuto-on25R3.2

Veeva Safety Workbench now allows users to reuse the same Excel template across Workbench Reports with different safety views. This is possible due to column tokens now using a generic namespace, enabling portability for reports that share the same columns. This feature streamlines report creation and makes generating new safety views more efficient.

Infinite Scroll on Dashboard DataAuto-on25R3.2

Veeva Safety Workbench introduces the Infinite Scroll option on Workbench Dashboard Components to view large datasets, eliminating the need to repeatedly navigate to the next page. The infinite scroll option loads all data (up to 100,000 cases per component) on a single page, which provides a more fluid and continuous browsing experience. Users can choose to display data using either the existing Pagination option or Infinite Scroll option. This customization allows users to align the dashboard’s behavior with their preferred way of consuming safety data.

SafetyDocs

PSMF Binder Periodic ReviewsConfiguration25R3.2

With this release, Veeva SafetyDocs supports the ability to configure periodic reviews for PSMF Binders, helping organizations to remain compliant by maintaining up-to-date PSMF content. This feature eliminates the burden of manually scheduling reviews and tracking review completion by automating review task assignment, allowing users to assess PSMF content and make updates as necessary. 

Literature Integration to PubMed EnhancementsConfiguration25R3.2

With this release, Veeva SafetyDocs significantly improves Literature Integration to PubMed, introducing flexible scheduling options by:

• Introducing weekly and monthly literature article search jobs, giving users the ability to precisely customize search frequency 
• Populating the URL on Literature Articles sourced from PubMed
• Adding warnings on the Search Term field of Literature Search Terms to reduce errors during automated searches

This update ensures increased flexibility in data retrieval, contributes to optimized system performance, and provides clearer job identification across all automated searches.

First Day of the Month ScheduleAuto-on25R3.2

With this release, Veeva SafetyDocs introduces a standard Schedule for the first day of month and a corresponding Schedule Component for creating custom Schedules. 

PVA: Defer Contact EntryConfiguration25R3.2

With this release, Veeva SafetyDocs provides greater flexibility for managing PVA obligations, allowing users to create obligations before sponsor or partner contact information is known. The ability to defer contact entry streamlines the obligation creation process, preventing delays caused by waiting for specific contact details, improving operational efficiency, and ensuring that critical safety tasks can be initiated faster.

PVA: MAA Document Required for DistributionAuto-on25R3.2

With the release, Veeva SafetyDocs now requires a document when creating a PVA MAA Document for Distribution, preventing distribution errors that occur when records are created without a specific document.

Terminate PVA Documents ActionAuto-on25R3.2

With this release, Veeva SafetyDocs reduces the manual effort required to maintain your PVA documentation in Vault by introducing the Make Agreement Documents Terminated action on the PV Agreement object. This action allows PVA documents to automatically transition states in accordance with their related PV Agreement’s state. This action replaces the Make Agreement Documents Superseded action. 

Safety Workbench & Safety Signal

Ability to Specify Product Families in Aggregate Reporting GroupsConfiguration25R3.2

With this release, you can specify Product Families in Aggregate Reporting Groups. These updates lay the foundation for the Signal Calculations for Product Family Combinations feature, which will allow users to select multiple Product Families to be used for combined signal calculations in a future release.

Safety Signal & SafetyDocs

Signal Review SchedulingConfiguration25R3.2

With this release, Veeva Safety Signal and SafetyDocs automate the scheduling of routine signal surveillance reviews by introducing automated creation of Signal Reporting Periods based on a predefined schedule for a Signal Product Profile. This feature eliminates the need for manual tracking in external tools like spreadsheets.

Safety, Safety Workbench, Safety Signal & SafetyDocs

26R1 Safety Suite Data Model and StandardizationAuto-on25R3.2

With this release, Veeva Safety adds several standard components to ensure customers can easily adopt best practices for major business processes. Additional Standardization capabilities will be available in upcoming releases. This release also relabels the study_has_arms__v field on the Study object to Single Arm Selection on Inbox Items.

QualityOne

QMS (QualityOne)

Print Record Support for CommentsAuto-on25R3.2

This feature allows Comments and associated user mention details on supported object records to be exported when an eligible user runs the Download as PDF action on a record. This enhancement improves clarity and context in the downloaded PDF and retains consistency with what users see in Vault at the time of export.

HACCP

Increase Batch Size Limit for Master Data DeletionAuto-on25R3.2

This feature enhances the process of deleting master data, such as Process Steps, Hazards, and so on. In Vaults with HACCP Plan Translation enabled, when a user deletes a master data record, Vault deletes the corresponding child translation records. Previously, users could bulk delete up to 26 master data records with 500 associated translation records at once if all 19 supported languages were active in their Vault. With this enhancement, users can bulk delete batches of up to 394 master data records and 7,500 associated child translation records in a single transaction.

RegulatoryOne

Registration & Dossier Management

Support Filtering on Managing Registrations from EventsConfiguration25R3.2

This feature enhances the actions to create Registrations and Registration Objectives and generate registration data on the Registration Items associated with an Event. When configuring the actions, Admins can populate the new VQL Criteria field to restrict the scope to only a subset of the Registration Items associated with an Event. For example, they can configure the actions to exclude Registrations in completed or cancelled states.

Exclude Matched Documents when Creating Dossier Documents from TemplatesConfiguration25R3.2

This feature enhances the Auto create document from template action to ensure it skips document generation for excluded matched documents. This allows organizations to prevent the automatic matching of specific documents at the Requirement level that are unlikely to match properly.

Veeva Claims

There are no Veeva Claims features in this release. The Claims Veeva Connect community offers general release communications, release highlights, and key feature demos for previous releases.