New in 25R3 Limited Release

Limited Release Dates: August 22, 2025 (25R2.2); October 3, 2025 (25R2.3); October 17, 2025 (25R2.4) | General Release Date: December 5, 2025

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

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

Platform

Highlights

Label SetsConfiguration25R2.2

Label Sets allow Admins to display alternative labels in the Vault UI within a single language to support use cases where different groups of users within a given country or region may have different terminology. Admins can set up new Label Sets in Admin > Configuration > User Interface > Label Sets:

Admins can create up to ten (10) Label Sets per language. Once a Label Set is created, Admins can define terminology using the Bulk Translation tool for any label in Field Labels:

Admins can use a new Label Set field on the User object to assign users who need to see labels defined in a Label Set:

Similar to translations, Label Sets are specific to the Vault UI, including Vault reports. Label Set labels are not supported in Vault Mobile, Vault API, Vault Loader, VQL, Vault Admin, Notification Templates, System Messages, User Account Emails, Configuration Migration packages, or the Audit Trail. Also, the following UI elements do not display Label Set labels: picklist values, object types, lifecycle states, and document types.

Learn more About Language & Region Settings.

Managing Data

Detect Duplicate Persons When Editing RecordsAuto-on25R2.2

The existing Duplicate Person Detection functionality has been extended to detect duplicates when existing Person records are edited.

Prior to 25R3, Vault only detected duplicates when Person records were created. Applying this detection to both creation and update of records helps further ensure that customers can better manage their Person directory and further reduce potential for duplication.

If a duplicate email address is identified while editing, Vault will display a message on the Email field:

If a potential duplicate is detected via other methods, such as an exact match of First Name and Last Name, Vault displays the Similar Records Found dialog box:

Vault will flag potential duplicates when a user is specifically editing a field defined in the Duplicate Match Rules:

For instance, based on the above settings, updating Email or First Name would trigger Vault to check for duplicates, but updating a Person’s Manager would not.

Learn more about Duplicate Person Detection.

User Experience

New LocalesConfiguration25R2.2

To better support global organizations, Vault will now include over 200 new Locale values. A user’s assigned Locale determines how dates and numbers are formatted in the Vault user interface, ensuring a familiar user experience. Supporting a wider range of Locale values reduces the potential that a user needs to be assigned a Locale that doesn’t match their standard localized formats for dates and numbers.

Learn more about Supported Locales.

Process Optimization

Action Triggers Support IsChanged FunctionConfiguration25R2.2

Action Triggers support the IsChanged() function to help users evaluate if fields have been modified so that Action Triggers are more efficient.

25R2 Update Trigger Best Practice

PriorValue($priority__c) != priority__c && priority__c = PicklistValue($priority__c, "high__c")

25R3 Update Trigger Best Practice

IsChanged($priority__c) && priority__c = PicklistValue($priority__c, "high__c")

Action Trigger Operator Menu Displays All OperatorsAuto-on25R2.2

The operator menu in the context aware editor now displays the full list of all Vault formula operators by category and sorts the suggested operators at the top of the list.

Workflow Job StepConfiguration25R2.2

A new workflow Job step allows Administrators to configure workflows that automatically start an eligible Vault Job then wait for its completion before advancing to the next step. The workflow Job step enables seamless integration with long-running, asynchronous work by tightly coupling the start and completion of a Vault Job within a single workflow step.

Multiple User Reference Fields for Workflow Participant GroupsConfiguration25R2.2

Workflow participant groups that use a user reference field to populate the group now support multiple user reference fields.

Analytics

Additional Relative Filters for DatesAuto-on25R2.2

When filtering on dates in reports, users now have additional relative filter options. These filter options allow for more dynamic filtering and reduce the need for users to adjust date filters on an ongoing basis.

The following new filter options are available:

• Today
• Yesterday
• Tomorrow
• Previous Week
• Current Week
• Next Week
• Is in the last full (years, quarters, weeks, months, or days)

Learn more about Using Report Filters.

Search Filters on Non-Primary Objects in ReportsAuto-on25R2.2

The new Search filter (introduced in 25R1) for Rich Text and Long Text fields in reports is now available to use on all objects in a report. With the initial release of this feature in 25R1, the Search option was only available to use for fields on the primary object in the report.

With 25R2, this filter is available on Rich Text and Long Text fields on all related objects in a report:

Extending this feature to all objects provides users the flexibility to filter their results without needing to be concerned with the structure of their report type.

Learn more about Using Report Filters.

Enhanced Merge Cells in Multi-Pass ReportsAuto-on25R2.2

When merging the cells in a multi-pass report, Vault now provides an additional option to only merge the cells if the cells are associated with the same primary record of the report view. This option is enabled by default when Enable merge cells with same value is selected.

Additionally, when exporting multi-pass reports with cell merging to PDF or formatted Excel, the exports now maintain the cell merging. If the report is included in a flash report, it also shows the merged cells in the email.

Descriptions & Footers on Dashboard ChartsAuto-on25R2.2

Users can now add a description and footer to dashboard charts. These options are added to the formatting section of each chart and make it easier to understand the content of the chart.

Support Ladder Multi-Pass Reports in DashboardsAuto-on25R2.2

Customers can now add reports with multi-pass ladder configuration to dashboards. They can be added to all chart types, and all chart functionalities are supported. A ladder multi-pass report is a report type that joins each secondary Report View directly back to the primary Report View:

Prior to 25R3, only chain multi-pass reports were supported for dashboards.

Admin Experience

Document Relationships Administration PageAuto-on25R2.2

Admins can now directly configure Document Relationship settings, providing direct control on which relationships are configured and the specific settings for each relationship. Admin > Configuration > Document Setup now includes the Document Relationships page:

Within this page, Admins can view all document relationships and create new document relationship types:

Within a relationship, Admins can also adjust relationship-specific settings, such as filters, doc types, and version-specificity settings.

Prior to 25R2, these settings could only be changed by submitting Support tickets.

Permission to manage Document Relationships is controlled by a new Document Relationships option in the Admin tab of Permission Sets. This permission is granted automatically for the standard System Administrator and Vault Owner security profiles.

Learn more about Document Relationships.

Delegate Access: Vault Owner Group RestrictionAdmin Checkbox25R2.2

Admins can now better control delegation of Vault Owner accounts by using the Delegate access allowed only among group members option on the standard Vault Owners group:

Prior to 25R3, this option could be used to constrain delegate access on all groups except the standard Vault Owners group. By supporting this on the Vault Owners group, customers can prevent a Vault Owner from delegating their account to a user who is not a Vault Owner.

The ability to control delegation based on group membership is dependent on the group-level setting as well as a Vault-level setting:

Learn more about Restricting Delegate Access.

Standard User LayoutConfiguration25R2.2

In 25R2, the User layout when viewing records from Users & Groups was updated to align the user interface with other objects in Vault and support full object layout functionality.

Building on this feature, Admins can now leverage a new standard User Layout that takes advantage of pages and layout rules to better organize the layout:

Like other standard layouts, an Admin can use the Save As function to create a copy of the standard layout and adjust as needed:

Learn more about Configuring Object Layouts and About the User & Person Objects.

Bulk Support for Document Text ExportAuto-on25R2.2

Building on the Document Text API released in 25R2, Vault Loader now allows you to set an Include Text checkbox when exporting documents. This setting generates a text file (.txt) for documents extracted that will contain their document text.

Bulk-Cancel Jobs in Queued or Queueing StateAuto-on25R2.2

Admins can now cancel in bulk certain jobs in the Queued or Queueing states. If there are jobs in the list that are not cancellable, they will not be cancelled.

Learn more about Managing Job Instances.

Performance & Availability

Increase User Role LimitsConfiguration25R2.2

A single user can now have up to 50 assigned user roles, increased from the prior limit of 15 per user. This enhancement provides customers with more flexibility in managing permissions granularly by allowing a larger number of distinct permission combinations to be assigned to a given user.

Scheduled Data Exports: Entity Modification LimitsAuto-on25R2.2

When modifying Scheduled Data Export configurations, the system enforces a strict limit of 30 entities. Customers with more than 30 entities in the configuration must remove entities until it is below the limit to save the changes.

Minor Enhancements

Picklist Field Search Behavior EnhancementsAuto-on25R2.2

When searching in picklist fields on objects, Vault will now treat searches as “starts with” rather than “contains”. This enhancement makes the picklist field search behavior consistent across Vault.

Prior to 25R3, searching picklist fields on documents or searching object picklist fields with over 100 values used “starts with” - only object picklists with less than 100 values used “contains”, which created an inconsistent user experience.

As an example, searching “Pur” or “Agree” will return the following types of results in this picklist:

However, searching “ment” would not return items with the term “Agreement”:

Hide Inactive Stages in UIAuto-on25R2.2

The Lifecycle Stage chevron UI will not display a stage when it is inactive and does not have any states configured for it.

Label Limit Increases for Attachment & Workflow Timeline SectionsAuto-on25R2.2

This feature applies the Section Help Content (255 characters increased to 500) and Section Label (40 characters increased to 150) limits to the Attachment and Workflow Timeline sections in object layouts.

Veeva Connections

Clinical Operations - EDC

Clinical Operations-EDC Connection: CTMS Managed Protocol DeviationsAuto-on25R2.2

This feature enhances the management of Protocol Deviations (PDs) that originate in EDC and are created in CTMS by the connection and managed within CTMS. This new functionality limits connection updates to connection created Protocol Deviations in CTMS to only specific fields on Protocol Deviation records to prevent overwriting information that has been updated within CTMS. The connection will now only update the Protocol Deviation Status in EDC and Deviation Date fields and will mark records as deleted if they are deleted in EDC. This ensures that the CTMS-managed records remain the single source of truth for Protocol Deviations and improves data integrity and oversight in CTMS. This feature applies to both Restricted and Unrestricted records.

Learn more about other new Clinical Operations features below.

Safety - EDC

Safety-EDC Connection: Improvements for Mapping, Merging & Error HandlingConfiguration25R2.2

This feature introduces several improvements to the Safety-EDC Connection, including:

• Mapping enhancements: A new EDC AESI field on the Case Adverse Event object maps to the CDMS Subject Adverse Event when users add Adverse Events when running the Add Relevant Subject Information action. Additionally, Admins can define custom Significance Criteria for the EDC AESI field, taking into account its value on both the Inbox Item and the Case.
• Error handling: When Inbox Item creation fails because the Organization of the Study or Transmission Profile is not of type Sponsor, Vault now displays a user warning to alert users of the issue.
• Merge support for auto-follow-up: When a second Inbox Item is merged as an additional Adverse Event, Vault tracks the associated Safety Case ID, preventing missed Case associations for subsequent follow-ups. To support this, the connection creates an additional Case Identifier record at the time of Case promotion, using the second EDC global_id as the identifier’s Name. This ensures that when future follow-ups are received carrying the second global_id, they correctly match to the original Case and are set to the Marked as Follow-up state.

Learn more about other new Safety features below.

QMS - RIM Registrations

Quality-RIM: Requires Correction State for Change ItemConfiguration25R2.2

This release introduces an enhancement to the Quality-RIM Connection that provides a new feedback loop for the Enhanced Change Control process. During the regulatory assessment step in RIM, users can now formally notify the Quality team that corrections are needed on a Change Control before the assessment is completed. This ensures that issues, such as a missing Product Variant, are resolved efficiently within the system, creating a clear audit trail of the correction process.

The feature introduces a new two (2)-step workflow managed by two (2) new lifecycle states:

1. Requesting a Correction (RIM-to-Quality):
   • A Regulatory user in the RIM Vault, while a Change Item is in the In Assessment state, identifies an issue.
   • They change the Change Item state to the new Requires Correction state.
   • Details of the required changes are entered into the new Correction Details text field.
   • The connection automatically updates the corresponding Regulatory Change Item in the Quality Vault to the Requires Correction state and syncs the details.
2. Confirming a Correction (Quality-to-RIM):
   • The Quality team is notified and makes the necessary updates to the Change Control.
   • Once complete, a QMS user changes the Regulatory Change Item state to the new Corrected state.
   • The connection notifies RIM, and the Change Item in the RIM Vault is automatically updated to the Corrected state.
   • The Regulatory user can now proceed with their assessment of the corrected item.

Key Benefits

• Improved Communication: Formalizes the feedback process between Regulatory and Quality teams.
• Increased Efficiency: Reduces delays by clearly flagging items that need correction without manual follow-up.
• Enhanced Compliance: Creates a clear, traceable history of corrections within the change control record.

Important Considerations

• This feature reuses existing connection points and does not require new integration rules, but relies on filters on the existing rules. The new states do not apply to Activity Change Item or Regulatory Activity Item records.
• Configuration is required to enable this feature.

Learn more about other new Quality and Regulatory features below.

QMS - Safety

Quality-Safety: Follow-Up & Single Intake Creation LogicConfiguration25R2.2

We’ve enhanced the Product Quality Complaint (PQC) connection between Quality and Safety Vaults to deliver faster, more accurate processing of PQCs with less manual effort. This update improves the handling of PQCs received by a Quality Vault from the source Safety Vault by reducing the number of Complaint Intakes initially created and automatically identifying follow-up Complaint Intake records.

Additionally, Safety Case Assessment records promoted to the Quality Vault will see the following improvements:

• Richer data regarding products: Vault now flags Complaints from the connection if they represent a combination device and pharmaceutical product as part of their context by capturing Reported Product information directly from the Safety Case as record relationships in the Quality Vault. This reduces the amount of back-and-forth between Quality and Safety teams during Complaints processing.
• Smarter follow-up processing: Follow-ups are automatically tagged and linked to the existing initial Complaint Intake and any applicable Complaints associated with the Complaint Intake. This automation eliminates the need for Quality users to manually identify and mark up new Complaint or Complain Intake records from the connection as follow-ups to existing records, which improves processing speed and accuracy.
• Clearer traceability to Case Assessments: We’re introducing the Safety Case Assessment object to Quality Vaults to ensure that the Quality Vault creates only the required number of Complaint Intake records, even if there are many Case Assessments in the Safety Vault that result in those Complaint or Complaint Intake records, and that the Quality team has visibility into all appropriate Case Assessments from the Safety team.

Together, this functionality works to ensure that Quality and Safety teams can work together more seamlessly in their core competencies, with higher quality data, for faster, more accurate Case and Complaint processing, resulting in fewer records.

Learn more about the Quality-Safety Connection.

Learn more about other new Quality and Safety features below.

RIM - Clinical Operations

RIM-Clinical Operations Connection: Updates to Regulatory Tracking for Clinical TrialsAuto-on25R2.2

The RIM-Clinical Operations Connection streamlines regulatory tracking by bridging RIM Vault and Clinical Operations Vault. Since 25R2, the Connection automatically transfers key regulatory approval information, including submission dates and verdicts, from RIM objects to Clinical milestones, preventing double-entry and ensuring data integrity for global initial clinical trial approvals like EU CTR.

While the Connection successfully streamlines regulatory data flow, it is crucial to recognize that Ethics Committee/Institutional Review Board (EC/IRB) approvals and EU Clinical Trials Regulation (EU CTR) final country approvals represent distinct and separate regulatory processes. This inherent difference demands a clear distinction in how these critical milestones are tracked within Veeva Vault. Using the EC/IRB Approval milestone for EU CTR has created challenges for consistent and accurate data tracking, leading some customers to use custom milestones as a workaround.

This new feature introduces an update to the Connection that supports transferring key dates and data to a new standard Final Country Approval milestone. This milestone is specifically designed for EU CTR, replacing the previous use of the EC/IRB Approval milestone for these trials. This change ensures standardized and comprehensive tracking of critical regulatory information within Veeva Clinical Vaults.

Learn more about other new Regulatory and Clinical Operations features below.

Clinical Operations

All Clinical Operations Applications

Editable External ID for Study Team RolesAuto-on25R2.2

External IDs are crucial for integrating data with external systems and ensuring consistency across the customer ecosystem. These IDs often need to be updated due to changes in external system configurations, data migration, or simply to correct errors. Previously, if Study Team Roles were assigned to Study Persons with Grant Access enabled, the External ID could not be modified without revoking individual access. This not only created a manual burden for Admins but also disrupted business continuity for end-users, as their access would be temporarily removed. 

This enhancement significantly simplifies the process. You can now directly edit the External ID field on Study Team Roles and Role Dependencies, even when those roles are in use by Study Persons with Grant Access set to Yes. This means you no longer need to revoke access or disrupt ongoing work to make these crucial updates, providing greater flexibility and efficiency in managing your study team configurations.

CTMS

Prevent Recalculate Enrollment Metrics for Transferred MetricsAuto-on25R2.2

The Recalculate Enrollment Metrics action now prevents users from applying it to Study records where the Metric Calculation is set to Transferred Metrics. External processes, such as Vault Loader or an integration, create the metric values for when a Study record uses Transferred Metrics. Therefore, recalculating these metrics within the system is not applicable. Users who attempt to use this action on a Transferred Metrics Study now receive an error message that indicates the action is only available for Studies where the Metric Calculation is set to Date-Based, Metrics Only, or Status Snapshot.

Recalculate Enrollment Metrics: Consistency & Error Handling ImprovementsAuto-on25R2.2

This feature introduces enhancements to the Update Metrics, Update Metrics (Metrics Only), and Recalculate Enrollment Metrics jobs to improve consistency and error handling.

The following updates are applicable to all the jobs:

• New job notifications 
• Updated job log details
• Handling of duplicate Metrics records
• Respect Metrics Not In Use and Global Subject Metric Enablement status
• Vault now uses Study Milestones as a fallback when Subject Group-specific Milestones are not defined

The following enhancements are job specific: 

• Update Metrics
  • The Update Metrics job is now scheduled and runs on a per-study basis
• Update Metrics (Metrics Only)
  • Update Metrics (Metrics Only) job is now scheduled and runs on a per-study basis. The label has also been updated for clarity from Update Metrics (Metrics Only Studies) to Updated Metrics (Metrics Only)
• Recalculate Enrollment Metrics
  • For Metrics Only Study records, adding or removing a Metric type from Metrics Not In Use no longer automatically schedules the Recalculate Enrollment Metrics job
  • When a Subject Group’s Track Enrollment Metrics field is changed from True to False, the Recalculate Enrollment Metrics action will no longer set existing Subject Group Metric values to zero (0), preserving historical data
  • For Date-Based and Status Snapshot Study records, the Recalculate Enrollment Metrics job now only creates new Metrics based on the Study’s subject data if a Metric record for that level does not already exist. The Seed Metrics user action or workflow system action can be used to create a full set of Metrics records
  • The Recalculate Enrollment Metrics job does not make changes when no Subjects exist for a Status Snapshot Study

Monitoring Event Review Comment BadgesAuto-on25R2.2

We have updated Monitoring Events to make it easier to locate and navigate to open comments.

Sections containing unresolved review comments now show a speech bubble icon on the section header and in the Navigation Panel. Clicking the icon automatically opens the relevant section, helping users find open comments faster.

Seed Metrics via User & Workflow ActionsConfiguration25R2.2

The ability to effectively plan and track subject recruitment metrics (screened, enrolled, randomized) is crucial for the success of any clinical trial as it directly impacts budget allocation or project timelines. Previously, Vault’s automated generation of these Metrics records was strictly tied to lifecycle state changes. 

This new feature introduces a dedicated user action to Seed Metrics Records. This on-demand action empowers users to manually generate Enrollment Metrics records at the Study, Study Country, and Study Site levels whenever they need to. This is the ideal solution for:

• Seeding Metrics records for new Study Countries or Study Sites added after the Study lifecycle state change
• Generating new Metrics records to include Arms or Cohorts that are added while the Study is in an Active state

Enrollment Rate Calculation ImprovementsAuto-on25R2.2

We’ve improved the way the system calculates Enrollment Rate (subjects per month) to provide a more accurate and realistic average. The previous calculation used a fixed 30 days per month. The updated calculation is now more precise, using 30.436768 (the average number of days per month).

In addition, the calculation now accounts for the enrollment period by factoring in the Last Subject In Milestone’s Actual Finish Date.

• When the Last Subject In Milestone has an Actual Finish Date, the system calculates the Enrollment Rate using the enrollment period: (Total Enrolled / # days between First Subject In and Last Subject In Milestone Actual Finish Dates) * 30.436768
• When the Last Subject In Milestone does not have an Actual Finish Date, the system calculates the Enrollment Rate based on the time elapsed since the start of enrollment: (Total Enrolled / # days since First Subject In milestone Actual Finish Date) * 30.436768

These updates are also made to the Enrollment Rate calculation for Monitored Metrics.

CTMS, Disclosures

Clinical Trial Notifications (CTN) for Japan Tracks Internal IRB ChangesAuto-on25R2.2

This feature enhances the scope of the CTN Change Log tracking to watch changes to the use of an Internal IRB at the site. These CTN Change Logs are also incorporated into the corresponding CTN section of the generated output. When used, the Internal IRB is always included with an Order value of one (1) in the relevant CTN section.

Clinical Trial Notification (CTN) Change Logs Display Reference NamesAuto-on25R2.2

This feature enhances CTN Change Log tracking to provide the related object name in the field displayed instead of the Vault object id when the change field is for an object reference, i.e. a Medical School change. This allows users to more easily understand the corresponding change when reviewing the change logs. Existing change logs with object ids are not updated with this release and are still supported.

Payments

Payments: Exclude from ThresholdConfiguration25R2.2

This feature introduces the ability to override existing payment thresholds. You can now designate specific Fees in a Fee Schedule or individual Payable Items to be paid regardless of any outstanding advances or predefined payment thresholds. This ensures that essential payments can be made to sites even when an advance has not yet been fully recouped or when immediate payment is otherwise required. This feature requires configuration to enable.

Restrict Payment Request to Study OrganizationConfiguration25R2.2

This new feature gives customers greater flexibility in managing Payment Requests. You can now prevent the automatic grouping of Payment Requests for a Study Organization within a Study. This allows for the tracking of specific costs tied to different entities or distinct cost structures, such as various purchase orders, so that your organization can maintain separate payment records for these items.

Generate Payment Request: Location Population with Multiple Study OrgsAuto-on25R2.2

This enhancement reduces potential data entry errors by only populating the Location field on the Payment Request if a single, consistent Location is specified across all related Study Organization records. If multiple, different Locations are found, the field will remain blank, ensuring data accuracy. This feature is Auto-on.

Site Connect

Auto-create System LinksAuto-on25R2.2

This feature automates Site System Link creation via Site Connect, thereby providing Veeva ID site users with seamless access to Veeva-owned systems like Vault EDC, Study Training, eCOA, and RTSM, all readily available from the System Links page in Site Connect.

This simplifies navigation for Veeva ID site users to the systems they already have access to and reduces the administrative burden of manually sharing these links with each Study for Sponsors/CROs, ensuring a more seamless experience for all.

When a Study is marked to use one of our connected applications, the system will automatically create a system link for it.

Revise & Return for Study or Country Level DocumentsAuto-on25R2.2

This feature enhances and simplifies Document Exchange for Sponsors/CRO’s by enabling sending study or country-level documents to Sites for a Revise and Return task.

This feature is particularly helpful for clinical documents, such as Protocol signature pages, that often originate as study-level or even country-level documents and when sites receive these documents, they must download, sign, and re-upload them back into the system to finalize them as site-level documents. An alternative approach currently used is Sponsor/CRO’s creating site-level copies of these documents and assigning these as Revise and Return tasks to Sites, which is cumbersome, time-consuming and  repetitive.

With this feature, when the document is returned from the Site upon completion of the task, the system creates a site-level document in the Vault.

Study Startup

Download Referenced Document in SurveyAuto-on25R2.2

To support wet-ink signing of CDAs, this enhancement allows survey respondents to directly download Reference Documents within Site Surveys and Outreach Surveys to their device. The download capability will only be available on documents within surveys that are sent after the 25R3 release.

Site Connect, Study Startup

Additional USN Sign Up EnhancementsAuto-on25R2.2

This feature focuses on enhancing the site USN search and sign up experience. When sites access the Sign Up page from a Site Survey, their First Name, Last Name, and Email will be pre-filled using the Person record from the survey invitation. If accessed from the Study Site Addresses tab, these fields will be pre-filled using the current user’s information. Any changes on the USN Search or Sign Up page will persist when navigating to the FAQ and back. 

This feature also includes updates to the sign up instructions and FAQ pages. The set of FAQs available through Surveys will differ from the FAQs available through the Study Site Addresses tab, ensuring that only relevant FAQs are available to sites. These enhancements are auto-on for all Vaults leveraging USN Sign Ups.

Study Training

Auto-Add Differentiated Security ProfilesAuto-on25R2.2

This feature automates Security profile assignments for Users coming over from Clinical based on what’s determined in the new Security Profile Mapping object records (security_profile_mapping__v). Training Admin users are able to set up these mapping records in Study Training. 

This allows Sponsor/CROs to leverage automated group permissions without manually updating the Security Profile for these users. 

If a mapping for a Security Profile is not set up, the Study Training-Clinical Operations Connection will create users with the standard “Training User” Security Profile by default.

Training Assignment Resolved Lifecycle StateConfiguration25R2.2

This feature introduces a new Resolved object lifecycle state for Training Assignments, to act as a terminal state for assignments and address specific scenarios that existing lifecycle states don’t adequately cover. These scenarios include:

• Learners dropping out of a study with incomplete Training Assignments that shouldn’t be canceled or marked as completed.
• Mistakenly assigned training that needs to be acknowledged as invalid without canceling it.

This new lifecycle state enables Sponsor/CROs to manually transition these assignments to the terminal Resolved state, providing a more accurate representation of their status and allowing for better tracking and management. The user can optionally record a Resolution Reason too.The records in this new state are ignored by the system for all future processing.

Auto-Sync Clinical User Status in Study TrainingAuto-on25R2.2

This feature ensures consistent treatment of user status across global directory by syncing a Clinical Operations user’s status with their Study Training user status. When a Clinical Operations User record Status changes to inactive or active, Vault updates their corresponding Study Training User record Status to match.

Synchronization is one-way only, from Clinical Operations to Study Training, and applies only to User records created or updated after this feature’s release.

Self Enrollment & Direct Assignment: No Due Date OptionConfiguration25R2.2

This feature enables Training Administrators to choose due date options for Direct Assignments and Self-Enrollment assignments. This includes setting a specific due date or no due date for those types of assignments. Prior to this feature, Training Assignments created via Direct Assignment or Self-Enrollment were required to have a Due Date. 

The ability to not set a Due Date allows Training Administrators to assign training that can be treated as optional. For example, a Learner may want to complete cross-training in another work area, but it is not a requirement for their job at the current time.

• Training Requirements can now have a specific Self-Enrollment Duration.
• Due Date is now optional for Direct Assignments.
• In the Open tab of the My Learning page, Learners can filter their Training Assignments by no due date.
• In addition to the Overdue, Due Soon, and Due Later categories of the Open tab, Learners can also see the number of assignments without a due date.

Display Latest Steady State Documents on Learner Task PageAuto-on25R2.2

With this feature, Learners can view the latest Steady State document related to a completed Training Assignment in the History tab. Previously, when accessing documents through the History tab, a superseded document would cause Learners to encounter a “Document Not Found” error.  

This feature provides Learners the ability to look back at previously completed training and access the current related document. This can be used as a way to quickly access the Library directly from assignments that the Learner knows they have already completed. 

• Vault presents the Learner with the latest Steady State document.
• A message is displayed telling the user which document version they actually trained on, as well as the version they are currently viewing. 

Training Homepages: Export FunctionalityAuto-on25R2.2

This feature enables Learners to export data from the Open and History tab as a CSV document. Previously, the History tab could only be exported as a PDF. These documents can also be exported from the My Study Team page. 

• The data exported is based on the current page filters. 
• In the My Teams tab, the assignments of the Open, Completed, and All tabs can be exported to CSV.

eCOA

Library Manager

Library Manager Enhancements Available for Use25R2.2

This feature includes the following enhancements to help Library Managers find and manage surveys more efficiently:

• Filter Changes: The Library includes new Status and Type filters to help you more quickly find the surveys you want, and it remembers your filter selections during each user session, only resetting selections after you log out of the site.
• Updated Survey Status: The New survey status has been renamed to Draft to better align with the survey creation workflow.
• Last Published Date: The Created Date column in the survey list has been renamed to Last Published to show the most relevant date for a survey’s current version.
• Download Survey Library Snapshot: You can now download a .CSV file of your entire survey library from the More Actions menu in the Library.

Studio

Update Between Schedules to Be Inclusive Auto-On25R2.2

This feature allows Between schedules to be configured so that when the event datetime falls within the window the survey is made available to the user.

New Survey Image Type: Joint Count Interactive Image Auto-On25R2.2

This feature enables study builders to add interactive joint count images to surveys. MyVeeva users or site staff can select specific joints on a body diagram to indicate tenderness or swelling. This new component allows sponsors to configure surveys for studies that require joint counts, a common assessment type for conditions like rheumatoid arthritis.

New Survey Image Type: Free Draw Image Auto-On25R2.2

This feature enables Study Builders to add interactive free draw images to survey. This image type enables the MyVeeva User or site staff to draw on a blank canvas to provide a more nuanced answer than a standard image or text answer would allow. This feature allows participants to create, erase, undo, and clear their drawings before saving them as part of their survey submission.

Commercial

PromoMats

Text Assets: Indication for Auto-LinkingConfiguration25R2.2

With this release, documents with specified Indications are only auto-linked to Claims with the same Indication via either the new Primary Indication field on the Claim object or the new multi-indication join object Text Asset Indication, or Claims where the Indication field is blank.

eCTD: Alphabetical Ordering Dependency RemovedAuto-on25R2.2

The Generate eCTD Compliance Packages bulk action no longer requires Product values to appear in the same order to correctly group materials for eCTD submissions. Previously, in Vaults where the Sort Multi-select Field Values in Alphabetical Order setting was not enabled, the system would not group documents together when the order of Product values was different.

Medical

MedInquiry

Send Emails to the Email Found in the Case ResponseConfiguration25R2.2

This feature enables the user to determine which of the related Case Contact email addresses the response package should be sent to.

In 25R1, the Case Contact data model was expanded to allow users to add multiple records of the same type of contact information. For example, if a Case Contact has more than one email address, users may add these email addresses as Email records related to the Case Contact. For cases where Case Contacts have multiple email addresses associated with them, this functionality can be configured to give users the option of selecting the appropriate email address at the time that they are drafting an email Case Response.

Only Show Steady State Documents in the Enhanced Fulfillment Document PickerAuto-on25R2.2

With this release, the Enhanced Fulfillment Document Picker now includes a Steady State Only filter by default. Admins can remove this criteria.

Steady State Only joins the Product, Country, and Language filters, which show only if those fields are populated.

Generate and Attach Case Report to Case Response or EventConfiguration25R2.2

This feature streamlines the generation and attachment of the Case Report to the Case Response or Event. Admins can configure a new user or entry action on a Case Response or Event object lifecycle state to attach the Case Report (created from the associated Word Formatted Output template) directly to the record.

Quality

QMS

Quality Teams: User Name HovercardAuto-on25R2.2

This feature adds hovercards to Quality Team members’ names, providing related user information.

Admins can configure which fields are displayed by selecting the Display in default lists and hovercards option for fields on the User object. This feature is automatically enabled by this release, which means hovercards will automatically appear when a user hovers on a Quality Team member’s name, showing all User object fields configured to display in default lists and hovercards.

Field Corrective Action: Ingest Reply from External PersonsAuto-on25R2.2

In this release, we are introducing a new feature that enhances the Field Corrective Actions (FCA) workflow by allowing recipients of External Notifications to reply directly to the notification email, with Vault automatically attaching the response to the corresponding Product Action record. This streamlines how acknowledgment forms, which are commonly returned via email, are processed by eliminating the need for manual handling. As a result, Vault ensures more accurate record-keeping, reduces manual tracking efforts, and improves overall process efficiency.

This functionality is especially critical during recalls or field actions, where acknowledgment from the Consignee is required to confirm a receipt of the notification and the agreement to take the appropriate action regarding the affected product.

Enable Auditing for Standard Legacy Migration ObjectsAuto-on25R2.2

We’ve updated the Legacy System Data data model objects to provide more control to customers who opt to bring this information into Veeva QMS. This feature allows Admins to turn on Auditing for the following standard objects:

• Legacy System
• Legacy Process Record
• Legacy Process Artifact
• Related Legacy Process Record

In prior releases, this function wasn’t available to Admins in the Vault UI. These changes unify the experience of viewing legacy and live records; both types of data now can display the Audit Trail user action, improving clarity and reinforcing consistency for Auditors reviewing legacy system information.

QMS Change Related Object Lifecycle State Action: Allow Download of Failed RecordsAuto-on25R2.2

In this release, we have enhanced the QMS Change Related Object Lifecycle State entry action to improve error handling and user visibility. When an error occurs while transitioning related records to a destination lifecycle state, users with the appropriate permissions can now download the job log file for detailed insight into the issue. Additionally, if any related records fail to transition successfully, the notification provides a link to download the failed records, enabling easier troubleshooting and resolution.

External Collaboration: Qualification & Organization QuestionnairesConfiguration25R2.2

The External Collaboration feature empowers customers to seamlessly manage interactions with external partners. It provides designated contacts from partner organizations with temporary access to a Vault in order to receive and complete tasks. Once tasks are completed, their access to the Vault is automatically revoked, ensuring security and efficiency.

With this release, External Collaboration functionality is expanded to Organization and Qualification records. This allows customers to send external partners tasks to complete questionnaires instantiated from Organization and Qualification records using the Veeva Vault Platform Checklist functionality. Organizations can use checklist questionnaires during the qualification and requalification process to gather comprehensive information about a supplier’s capabilities, quality management system, compliance, and overall reliability. This feature provides a robust tool for enhancing communication and data gathering with your external contacts.

The screenshots below show an external collaborator’s user experience receiving a task to complete a checklist questionnaire for an initial qualification to become a material supplier.

Checklist questionnaires are designed and approved by your Business Admin before use, ensuring that they meet your specific organizational needs. Learn more about working with checklists. Prior to sending a checklist questionnaire to an external partner, Admins must configure the External Collaboration feature. You can learn more about configuring External Collaboration for checklist questionnaires.

Reassign External Collaborator on ChecklistsConfiguration25R2.2

Organizations often encounter situations where an assigned external collaborator becomes unavailable for an active workflow task. Until now, it was not possible to reassign external collaborators on checklists linked to these workflow tasks. This disrupted critical business operations that rely on external partners completing checklist questionnaires, such as pre-audit assessments or supplier qualifications.

With this release, the Reassign External Collaborator feature now supports the reassignment of external collaborators on both the workflow task associated with an object record, and on any associated in-progress checklists. This crucial enhancement ensures uninterrupted execution of external partner workflows, particularly for processes involving checklist questionnaires.

Upon execution of the Reassign External Collaborator action, Vault prompts the user performing the reassignment to select a new external collaborator.

The newly selected external collaborator is assigned to the associated checklist’s active workflow task, and becomes the new targeted respondent for the in-progress checklist.

Vault also updates the External Collaborator field on the checklist’s parent record.

Enabling this expanded reassignment capability for both workflow tasks and their associated checklists requires configuration by an Admin. Admins can configure the Reassign External Collaborator action to include checklist reassignment on any lifecycle of objects supported for External Collaboration.

Quality Record Checks with Non-Editable Prompts: Display Exact Match Field ValuesAuto-on25R2.2

For customers using Quality Record Checks with editable prompts turned off, exact Matching Fields now display corresponding values derived from the record being evaluated. The before and after images below demonstrate this change.

This feature is automatically enabled in this release.

Batch Release

Genealogy Check Using Bill of MaterialsAuto-on25R2.2

The Genealogy Batch Disposition Check can use the standard bill of materials (BOM) for Related Material records to locate Quality Events in a batch’s genealogy that are tied to materials, like Change Controls, without requiring the full batch genealogy. This feature introduces a new object, Material Genealogy, for this process.

Close Disposition ItemsConfiguration25R2.2

Users can make decisions, optionally add justifications, and close individual Disposition Check Items on the Batch Disposition Execution page. Admins can enable this feature by setting the Check Requirement Item Behavior picklist to Automatic & Manual.

Surveillance

PMDA: Truncation and Validation Rules UpdateAuto-on25R2.2

In line with continued investment for PMDA support introduced in 25R1, in this release we are updating the truncation rules to better align with health authority specifications. These improvements ensure a better user experience and greater compliance with PMDA requirements.

QualityDocs

Process Navigator EnhancementsAuto-on25R2.2

User Preference for Preferred Visual Hierarchy Type Default in Process Navigator

Users are able to set their preferred default object type for the Process Navigator Landing Page, providing a more customized experience.

On the Process Navigator Homepage, a new Set Default Process Hierarchy button allows users to select a default object type for their Process Navigator Homepage. This preference overrides the default based on the Visual Hierarchy object’s default Object Type. When users do not set a user preference, Vault applies the existing default object type setting logic.

Process Navigator document links open in new tabs

Prior to this release, document links from Process Navigator Favourites and Details Pages will open in new pop up windows. In this enhancement, document links opened from Process Navigator Favorites and Detail Pages will open in new Tabs, making user experience consistent with opening document links from the Process Navigator Homepage.

Icon field Optional on Process Navigator Homepage for Root Parent Process

Prior to this release, the Icon field on the Process Navigator Homepage for a Root Parent Process was required. In this enhancement, users can create a root process without defining the Icon field, providing a consistent experience.

Manually associated documents with inactive Hierarchy Document records will not display in Process Navigator

In this enhancement, when a Hierarchy Document record is inactive, the corresponding manually-associated document will not be displayed in either the Process Navigator Homepage or the Process Navigator Detail Page. For dynamically-associated documents, as the dynamical association relationship is based on association rule instead of the Hierarchy Document record, dynamically-associated documents with a valid association rule will continue to display in both pages.

Ability to Disable the Relationships PanelConfiguration25R2.2

An Application Setting checkbox allows Admins to disable the standard Document Relationship panel to help avoid user confusion and redundancy if using the Document Relationships section in the Quality Relationships panel.

Training

Training Assignment Resolved Lifecycle StateConfiguration25R2.2

This feature introduces a new Resolved object lifecycle state for Training Assignments, to act as a terminal state for assignments and address specific scenarios that existing lifecycle states don’t adequately cover.

For example, when a person is given a Training Assignment by mistake, it can now be moved to the Resolved state, instead of the Cancelled state.

This new lifecycle state enables Training Admins to manually transition these assignments to the terminal Resolved state, providing a more accurate representation of their status and allowing for better tracking and management. The records in this state are ignored by Vault for all future evaluation.

This is primarily a Veeva Study Training feature, but may be used in Veeva Training where applicable.

Self Enrollment & Direct Assignment: No Due Date OptionConfiguration25R2.2

This feature enables Training Administrators to choose due date options for Direct Assignments and Self-Enrollment assignments. This includes setting a specific due date or no due date for those types of assignments. Prior to this feature, Training Assignments created via Direct Assignment or Self-Enrollment were required to have a Due Date.

The ability to not set a Due Date allows Training Administrators to assign training that can be treated as optional. For example, a Learner may want to complete cross-training in another work area, but it is not a requirement for their job at the current time.

• Training Requirements can now have a specific Self-Enrollment Duration.
• Due Date is now optional for Direct Assignments.
• In the Open tab of the My Learning page, Learners can filter their Training Assignments by no due date.
• In addition to the Overdue, Due Soon, and Due Later categories of the Open tab, Learners can also see the number of assignments without a due date.

Display Latest Steady State Documents on Learner Task PageAuto-on25R2.2

With this feature, Learners can view the latest Steady State document related to a completed Training Assignment in the History tab. Previously, when accessing documents through the History tab, a superseded document would cause Learners to encounter a “Document Not Found” error.

This feature provides Learners the ability to look back at previously completed training and access the current related document. This can be used as a way to quickly access the Library directly from assignments that the Learner knows they have already completed.

• Vault presents the Learner with the latest Steady State document.
• A message is displayed telling the user which document version they actually trained on, as well as the version they are currently viewing.

Training Homepages: Export FunctionalityAuto-on25R2.2

This feature enables Learners to export data from the Open and History tab as a CSV document. Previously, the History tab could only be exported as a PDF. These documents can also be exported from the My Team page by the Learner’s Manager.

• The data exported is based on the current page filters.
• In the My Teams tab, the assignments of the Open, Completed, and All tabs can be exported to CSV.

LIMS

Test Execution: Instrument Integration EnhancementsConfiguration25R2.2

In this release, we are improving the experience of using integrated instruments during Test Execution. Users can trigger requests for data from instruments directly from a Result or manage them through a separate integration partner URL. Enable this feature by creating a relationship between integrated Inputs and Result Definitions within the Test Definition.

Block Reopening Tests on Imported Batches Instead of Blocking Reopening Spec ExesAuto-on25R2.2

In this release, we are relaxing the limitation that blocks the reopening of a Batch Release Spec Execution that has results being used by a Stability Initial Timepoint’s Spec Execution. Moving forward, users can reopen the approved Batch Release Spec Execution; however, the system blocks Tests from being reopened unless the Stability Initial Timepoint’s Spec Execution is reopened first.

T0 Use Batch Results: Add Sorting & Filtering for Sample & Sample Type ColumnsAuto-on25R2.2

In this release, we are adding sorting and filtering capability to the Sample and Sample Type columns of the match selection grid in the popup dialog when selecting Batch Release Tests to use for a Stability Study’s Initial Timepoint.

Improved Merging of Criteria Rows in Stability ExportAuto-on25R2.2

With this release, in a Stability Export Report, Spec Data Criteria with identical Spec Data Criteria on the same Result are now merged based on criteria formula into a single row in Excel, even if their descriptions differ. This reduces duplication and improves readability.

Support for Generate Document from Formatted Output Actions in LIMSAuto-on25R2.2

With this release, LIMS now supports the Generate Document from Formatted Output action as both a User Action and an Entry Action. Both actions can be added in LIMS Vaults.

Test Set: Updated UI for Ordering SamplesAuto-on25R2.2

With this update, we have made several minor User Interface improvements for ordering and reordering Samples in a Test Set including updating the Drag & Drop styling.

Create Variation Result Action Excludes Certain Result RecordsAuto-on25R2.2

The Create Variation Result action no longer shows Results with Aggregate Variables or Cross-Test Variables.

Enhanced Validation to Prevent Loops with Calculated ResultsAuto-on25R2.2

When a Spec Data is made effective, the system now performs an additional check to ensure that there are no loops with Calculated Results that could prevent a Test from being completed.

Prevent Duplicate Documents from Being Added to Test Definitions & Test SetsAuto-on25R2.2

The same document and version combination cannot be added to the same Test Definition or Test Set more than once.

Update Expected User Permission for Certain ObjectsAuto-on25R2.2

Users are now only required to have Read object permission for the following objects:

• Criteria Evaluation Set
• Criteria Evaluation History
• Lab Investigation Request

Lab Sample: Select Sample Action Automatically SetAuto-on25R2.2

When a user manually sets the Selected Sample field on a Spec Execution Sample Action of type Select, the Spec Execution Sample Action field on the Sample record now automatically references that Spec Execution Sample Action record.

This was already done with AutoMatch set to Yes. With this release, it also occurs when AutoMatch is set to No.

Sibling Check Related Record State Change Entry Action Available in LIMSAuto-on25R2.2

The Sibling Check Related Record State Change entry action, which allows the action to execute based on the lifecycle state of sibling records, is now available in LIMS Vaults. Previously, this action was only available in Quality Vaults.

Add Samples to Empty Test SetConfiguration25R2.2

With this release, users can create an empty Test Set and add Tests to it from the Test Set record. Previously, it was necessary to begin a Test in order to create a Test Set to which it is added.

Spec Data Object Type Can No Longer Be ChangedAuto-on25R2.2

Once a Spec Data is created with a certain object type, its object type cannot be changed.

Regulatory

RIM Core

Active Dossier Viewer - Filter by SectionAuto-on25R2.2

A new Section filter is now available in the Active Dossier Viewer. This feature allows users to easily navigate large dossiers by filtering the view to show only records belonging to specific sections. You can select up to 50 sections to display records from, making it simpler to find the information you need and improving the overall user experience.

When you select a section, all of its parent sections will also be visible up to the Root. For example, if you filter by 3.2.S Drug Substance, its parent sections (3.2 Body of Data, 3 Quality, and the root level) will also be displayed. All of its child sections will also be displayed down to the lowest level that contains Active Dossier records (for example, 3.2.S.1 and 3.2.S.2, and their records).

The Section filter is a secondary filter. It becomes available for use only after you have selected a Root Active Dossier Template (ADT) and at least one other primary filter (transactional or non-transactional).

Prerequisites for Optimal User Experience

For the new filter to be useful, an administrative update is required. The Section filter displays the Name (name__v) field from Active Dossier Templates (ADTs). Since this Name field was originally provided as a technical code (e.g., ADT-000003), Vault Admins need to update it to match the more descriptive Display Name (display_name__v) (e.g., 3.2.S Drug Substance).

To assist with this update, a Loader Sheet will be available with this release. Contact your Managed Services team or Support for the template and instructions.

RIM Submissions

Content Plan Viewer: Header Styling UpdateAuto-on25R2.2

The Content Plan Viewer grid now has a new appearance to support additional filtering for Global Content Plans. The header row now contains a new gray background, with additional space to support special filter dropdowns for GCPs, such as View by Activity and View as Root. While the styling changes specifically support GCPs, all Content Plans (including SCP and RLCP) will display the new styling:

RIM Publishing

Tunisia eCTD 3.2 Publishing & Validation (TN v1.1)Configuration25R2.2

Veeva Publishing now supports Tunisia eCTD (ICH eCTD specification 3.2) publishing and validation, based on the National Agency for Medicines and Health Products (ANMPS) regional specification package v1.1. Publishing customers can build eCTD Submission Content Plans including a new TN Module 1 template, include optional STFs or node extensions, publish compliant submissions per XSD v1.1, and validate per the ANMPS Validation Criteria v1.1.

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

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

European Union eCTD 3.2 Validation (EMA v8.2) 25R2.2

Veeva Publishing now supports the new EU eCTD M1 specification version 3.1.1 and validation criteria version 8.2.

The new validation criteria (v8.2) will be mandatory for all v3.1.1 electronic submissions to National Competent Authorities (NCAs) and EMA starting December 1, 2025.

The submission timeline is as follows:

• June 2, 2025 – September 30, 2025 (Initial Period): Only eCTD submissions compliant with EU M1 v3.1 and validation criteria v8.1 are accepted.
• From October 1, 2025: eCTDs compliant with either EU M1 v3.1 or v3.1.1, and validation criteria v8.1 or v8.2, will be accepted.
• From December 1, 2025: Only eCTDs compliant with EU M1 v3.1.1 and validation criteria v8.2 will be accepted.

EU publishing will require configuration to encompass the above changes, which can be provided to customers via VPK to aid in deployment.

Non-PDF Documents will not display results in Link EvaluatorAuto-on25R2.2

As links are not published in non-PDF published output, non-PDF document links will no longer appear as actionable in Link Evaluator. Veeva Publishing does not modify source files when the Source of Published Document (SOPD) value is Source Document. Therefore, if non-PDF source documents contain external hyperlinks, link information that appeared previously was inactionable, and often inaccurate.

Key Changes:

When the source of an external document hyperlink is a non-PDF document, the linking rules will appear as Not Executed. This new rule value more accurately reflects how SOPD Source files are handled by the system.

Link Evaluator results will be empty for non-PDF files that contain external hyperlinks, as these links can be neither suppressed nor retargeted.

Add Bookmark Level Column to Edit Table of Contents PageAuto-on25R2.2

A new column, Bookmark Level, is now available on the Edit Table of Contents page. Bookmark Level values will provide users a convenient reference to specify which level of bookmarks they want the Include Bookmarks to Defined Level action to include. 

Impact: The new column display will be available for users of system-generated TOCs in Submission Content Plans and RLCPs. Key Changes: Previously, the Level column on the Edit Table of Contents page did not apply to both bookmark actions. To improve the end user experience and reduce TOC editing rework, users can reference the bookmarks to be included in their TOC as follows:

Include bookmarks to defined level: 

• Users can launch from the Root, Content Plan, or Content Plan Item level
• Users will reference the new Bookmark Level column, which includes filtering and an information dialog icon
• The value will correspond to the level the bookmark is away from its parent 
• The information presented with more logical values (e.g., selecting ‘2’ will include Levels 1 & 2)

Include all to defined level: 

• Users will continue to launch only from the Root level
• Users will continue reference the existing Level column and filters

Support Table of Contents Linking for Duplicate Matched ContentAuto-on25R2.2

When the same source document in a Content Plan has been matched to multiple Content Plan Items, and each CPI has a unique Published Output Location value, the separate system-generated Table of Contents entries will link to each document individually. 

Impact: This new TOC linking behavior is particularly valuable for non-eCTD submissions, where the same document may be matched to different sections with the intent of being published multiple times (instead of using Reference Leafs). The new linking behavior will also be reflected in RLCPs or eCTD SCPs where Reference Leafs are not in use. 

Key Changes: While Reference Leaf creation is not used for non-eCTD submissions, previous iterations of the system-generated TOC did not reflect this difference and links could target any of the instances of the matched source file. With this release, TOC target links will more accurately reflect the published output.

RIM Registrations

Impact Assessment EnhancementsAuto-on25R2.2

This release includes enhancements designed to streamline and facilitate the management of the impact assessment process. The following changes provide new flexibility for administrators and improve the workflow for all users.

What’s New for Users

• Simplified Country Scoping (IARs): When you run an impact assessment report (IAR) from an Event and the Report Type includes the Registration > Country filter, Vault now automatically pre-populates that filter with the countries defined as Event Country records (the Event Country object was introduced in 25R2). This removes the need for manually filtering the report once created. You can still modify the list of countries to narrow the scope for a specific report run.
• Simplified Country Scoping (Create Related Records): When you run the Create Related Records action from an Event, the wizard automatically pre-populates the Event Countries. However, if you deselect all countries, the action is not limited to the Event Countries and will apply more broadly.
• Optional Prompts: You can now use IARs that include optional prompts, giving you more flexibility when running a report.

Areas for Admins to Consider

Admins have now new opportunities to optimize their report configurations. Here are a few areas you may want to review:

• Look for opportunities to combine reports: Admins can review their existing IARs to see if multiple reports can be consolidated into a single one using optional prompts. This can help simplify the user experience and reduce the total number of reports to manage.
• Evaluate existing prompts: Consider whether any current reports with required prompts could be more flexible with an optional prompt.
• If you have the Registration > Country filter in your IAR Report Types: We recommend setting this filter as optional. This will allow the system to automatically pre-populate the countries from the Event Country records (if they exist) while still giving users the flexibility to manually adjust the country scope or skip the filter in the prompt.
• If you want to use the functionality related to the Event Country object: You must ensure the Registration > Country filter is included in your Report Types as an optional filter. You will also need to add the new Event Countries section to your Event object page layouts.

EUDAMED Container Packages Submission GenerationAuto-on25R2.2

Vault RIM users can now generate UDI-DI Container Packages submissions for medical devices registered in the European Union. This feature allows you to create compliant XML submissions for all levels of device packaging that are not the smallest unit of use, such as boxes or shipping containers.

When you add or update packaging information for a registered device, you can now generate a submission specifically for those container packages. In the Select UDI Submissions dialog, choose the new UDI-DI Container Packages option from the UDI Submission Type picklist. Vault automatically compiles all relevant package information from related registrations.

This feature also introduces the Enable default EUDAMED XML Version setting, providing the ability to set a default value for the XML Version when generating an EU UDI Submission. This replaces the manual effort of entering the XML Version when a newer version is required but there have been no XSD updates for UDI submissions. This feature saves you from manually entering a version for each submission and helps manage different version requirements for EUDAMED’s Playground and Veeva RIM environment, as XSD versions can differ.

RIM Submissions Archive

Tunisia eCTD 3.2 Archive & Viewing (TN v1.1)Auto-on25R2.2

With this release, Submissions Archive supports importing, viewing, and exporting of Tunisia submissions using the ANMPS regional specification v1.1.

Viewing eCTD 4.0 Keyword OptimizationAuto-on25R2.2

To improve the eCTD 4.0 Submissions Archive Viewer experience, Health Authority eCTD Keywords will now be populated in grid cells of Selected Columns, and only for individual documents. The Viewer will not display content at the Section level. This provides essential context at the document level without adding redundant information or complicating the Viewer display unnecessarily.

Key Changes: Health Authority eCTD Keywords will be removed from Section-level rows and will only be displayed in grid cells at the document level.

Impact: These changes apply when using Submissions Archive Viewer to view published or imported eCTD 4.0 submissions.

Hide Cumulative View for Japan eCTD 3.2 SubmissionsAuto-on25R2.2

To provide a cleaner, more intuitive experience in the Submissions Archive Viewer, the Cumulative View action is no longer shown for Japan eCTD 3.2 submissions. This view is not compatible with the JP XSD 1.0 Cumulative XML format (eCTD 3.2). The Historical Lifecycle of Document user action remains supported in Japan eCTD 3.2 submissions.

The previous availability of the Cumulative View in the Action menu was an invalid action for Japan eCTD 3.2. To prevent user confusion when trying to launch this nonfunctional view, the user action has been automatically removed from the Archive Viewer actions.

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.

In addition to the below release notes, the Safety and SafetyDocs Veeva Connect communities offer general release communications, release highlights, and key feature demos.

Safety

Combination Product Type IdentificationConfiguration25R2.2

With this release, Veeva Safety adds the Combination Product Type field to the Product object, which clearly identifies when Combination Products include drugs, devices, or both. Vault populates the field based on the related Product Constituents and their Product Registrations.

Auto-Code CAS Numbers for Case External ProductsAuto-on25R2.2

With this release, Veeva Safety automatically identifies and maps Chemical Abstracts Service (CAS) numbers to Case Product Substances created when a user codes an External Product using the WHODrug Search browser. As CAS numbers are required for submissions to the Korean Ministry of Food and Drug Safety (MFDS) and optional under ICH E2B(R3) guidelines, this enhancement streamlines regulatory compliance by reducing the manual effort necessary to produce accurate substance-level information.

Exclude Concomitant Products from Auto-CodingAdmin Checkbox25R2.2

With this release, Admins can exclude concomitant products from auto-coding against the Product library during structured intake, including E2B, JSON, and CSV files. When promoting Inbox Items to Cases, Vault classifies concomitant products as External Products. Previously, Vault attempted to match concomitant products to Products in the Product library. This enhancement addresses a common challenge where concomitant medicinal products are classified as company products, resulting in the need for manual correction.

Auto-Update Related Case Identifiers in Case RelationshipsConfiguration25R2.2

With this release, following changes to the related Case on a Case Relationship record Vault can automatically update the Related Case Identifier value with either the UID or Worldwide UID of the new related Case. This eliminates the need to manually update this information, which is particularly helpful in scenarios involving literature or legal cases where multiple related Cases are linked. This feature reduces manual data entry, minimizes errors, and improves the accuracy and consistency of linked case data, ultimately enhancing operational efficiency and user productivity.

Updated SUSAR Tagging BehaviorAuto-on25R2.2

With this release, Vault tags Cases as SUSAR only when the report type is classified as Study. This update resolves situations where Vault tagged Cases with a report type of Spontaneous as a SUSAR if they referenced a Study with unspecified products. In such cases, Vault previously allowed SUSAR tagging on Cases or Case Assessments despite the report type not meeting the criteria. This ensures SUSAR tagging is correctly restricted to Study reports, ensuring more accurate classification and compliance with regulatory standards.

Tag Only Clinical Trial Study Cases as SUSARAdmin Checkbox25R2.2

With this release, Admins can configure their Vault to tag Case Assessments as SUSAR only when they are associated with a clinical trial study. Previously, Vault tagged SUSARs on any Case with the Report Type set to Study, regardless of the study type. By improving tagging accuracy, reducing the risk of misclassification, and ensuring compliance with regulatory definitions, this enhancement supports higher-quality data and more reliable safety reporting.

Blinded Cases Rule Evaluation for AgenciesConfiguration25R2.2

With this release, the Veeva Safety Reporting Rule Engine supports the ability to determine agency reportability for blinded clinical trial Cases. This feature helps satisfy regulatory requirements for health authorities where blinded Serious Adverse Event reporting is required.

PMDA: Clear Non-Reportable Case Product RegistrationsAuto-on25R2.2

With this release, when processing PMDA-reportable Cases, the Retrieve Reportable Case Product Registrations action on Localized Cases now removes non-reportable Case Product Registrations if no PMDA-reportable registration exists for the Product. Previously, these non-reportable registrations remained on the Case.

Allow Case Data Expressions to Reference Inbound TransmissionsConfiguration25R2.2

With this release, Veeva Safety extends the Case Data - Expression parameter to allow references to Inbound Transmissions for Safety Reporting Rules and Validation Criteria. This enhancement provides additional reporting flexibility, allowing for tailored evaluation criteria without the need for custom SDK development.

FDA MedWatch 3500A (August 2024 Version): Compounded Product UpdateAuto-on25R2.2

With this release, Veeva Safety adds support for the G.4 Compounded Product field on the FDA MedWatch 3500A (August 2024 version) form. Across all Case Products in sections C and D, if any component of a Product has an FDA Product Registration with a Compounding Type value, Vault now selects the G.4 checkbox on the form.

MFDS E2B(R3): G.k.i.2.r.3.KR.1 Export UpdateAuto-on25R2.2

This release updates how Vault populates the G.k.9.i.2.r.3.KR.1 WHO-UMC Result of Assessment data element when generating MFDS E2B(R3) files for domestic Cases that are not associated with a study. If the Localized Case Assessment Result does not contain a Localized Assessment Result value, Vault exports a value based on the Assessment Result on the Case Assessment Result.

Sender-Based Inbound Validation CompatibilityConfiguration25R2.2

With this release, Admins can now enable Sender-Based Inbound Validation for inbound sources that also use Automated Case Promotion or Local Intake Auto-Translation for E2B transmissions received via the AS2 Gateway or Vault API. 

Safety Workbench

Navigate to a Safety Object from WorkbenchAuto-on25R2.2

This feature allows users to directly access related Safety object records, such as Cases or Products, from Workbench Dashboards and Workbench Report Excel outputs. Users can now select a link to view or modify detailed information within Veeva Safety. This creates a seamless workflow and eliminates the need to search for records in separate tabs.

Filter a Workbench Report by Signal Case SeriesAuto-on25R2.2

This feature allows users to filter Workbench Reports using Signal Case Series, constraining results in the report output to only the Cases within that series. This enhances targeted reporting and analysis by leveraging existing signal data for more precise insights in Veeva Safety Workbench.

Filter a Workbench Report Using Starts With and Contains OperatorsAuto-on25R2.2

With this release, Veeva Safety Workbench allows users to filter reports using the starts with and contains operators for text fields. This enhances data search flexibility, enabling users to easily find specific information, such as lot numbers, directly within Workbench Reports.

SQL Editor EnhancementsConfiguration25R2.2

Veeva Safety Workbench introduces improved UI for the SQL Editor section on safety views, which includes syntax highlighting and line numbers. Keyboard shortcuts are also now available for the SQL editor. This feature enhances the experience of writing and reviewing custom SQL views, boosting user efficiency for advanced reporting.

Clearer Error Handling for SQLAuto-on25R2.2

This feature allows users configuring safety views to see SQL error messages when saving or previewing a view. Users can also download a log file to troubleshoot more complex queries. This feature provides essential troubleshooting tools for custom SQL development, reducing reliance on Veeva Support and enabling faster issue resolution for reporting teams.

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

Export a Workbench Dashboard Component as CSVAuto-on25R2.2

This feature allows users to export data directly from a Workbench Dashboard Component to a CSV file. This enhances data analysis flexibility, enabling users to easily extract filtered dashboard data for further use in documents or spreadsheets.

Workbench Standard ReportsSupport25R2.2

With this release, Veeva Safety Workbench introduces the following standard Workbench Reports: 

• Adverse Event Summary
• Clinical and Post-Market Line Listings
• Lot-Based Safety Listings
• Review by Age Group
• Global Report Set
• AOSE (Analysis of Similar Event) 
• Agency Tracking
• Transmission Report
• Partner Transmission Report

Safety Signal

Successful Record Creation During Scheduled CalculationsAuto-on25R2.2

During scheduled Signal Calculation runs, if some parts of the data creation fail, Vault now retains the records that were successfully created, such as Product-Event Combinations, PEC Periods, and Statistical Data, to allow you to access successfully processed information.

SafetyDocs

Clearer Error Handling When Generating PSMF PDFsAuto-on25R2.2

With this release, Veeva SafetyDocs introduces a clearer error message when a user attempts to run the Generate PSMF PDF action on a PSMF Binder containing a placeholder document of type PSMF Generated Report with missing required fields. 

Convert HTML Markup in Literature AbstractsAuto-on25R2.2

With this release, Veeva SafetyDocs  converts HTML markup in the Abstract field of Literature Articles imported from external databases to formatted text.

Product Family Support for PV AgreementsConfiguration25R2.2

With this release, Veeva SafetyDocs supports the classification of PV Agreements at the Product Family level enabling more efficient agreement management and improving scalability across product portfolios. Previously, PV Agreements could only be classified at the Product level.

Risk Measure Support for EMA GVP Module XVI Revision 3Auto-on25R2.2

With this release, Veeva SafetyDocs aligns with the EMA’s updated guidance on the categorization and subcategorization of additional risk minimization measures (aRMMs), by introducing new picklist values to Core Risk Measures and Local Risk Measures in accordance with EMA’s guidance to support GVP Module XVI Revision 3.

Safety & Safety Workbench

Transmission: Sent & Completed DatesAuto-on25R2.2

This feature introduces two new standard fields on Transmission objects: Transmission Sent Date and Transmission Completed Date. This provides a standardized way to capture and track the exact dates of Transmission events, improving visibility into compliance for Submissions, Distributions, and Early Notifications.

Safety & Safety Signal

Simplified Deletion for Case Products & Case Adverse EventsAuto-on25R2.2

With this release, Veeva Safety supports deleting Case Products and Case Adverse Events with a single click. Deletions cascade to associated records and clear references in related records. Previously, users had to manually delete multiple records across various objects, which was time-consuming and error-prone. This enhancement saves time, reduces manual effort, and minimizes the risk of data inconsistencies during Case processing.

Safety Workbench & SafetyDocs

Scheduler EnhancementsConfiguration25R2.2

This feature introduces several improvements to the Veeva SafetyDocs and Veeva Safety Workbench scheduling capabilities:

• Additional monthly Schedules: Vault introduces standard Schedules for the last day of the month and the first selected day of the week each month, and corresponding Schedule Components for creating custom Schedules.
• Enhanced support for end-of-month scheduling: Monthly scheduling now adjusts to months with fewer days. If a selected day doesn’t exist in a given month (e.g., 29th, 30th, or 31st), Vault schedules the event on that month’s last day and returns to the original scheduled day for the next applicable month. This includes leap year handling for February 29.
• Audit trails: Date changes on scheduled events will now be shown in audit trails.

QualityOne

QualityOne

Error Message EnhancementsAuto-on25R2.2

With this release, users now see more user-friendly wording on validation error messages, and impacted fields on the object record are now referred to by their user-facing label values. Prior to this release, validation error messages referenced impacted fields by their API names only rather than their labels (for instance, inspection__v rather than Inspection).

QMS (QualityOne)

5 Whys Analysis: Increased Global LimitsAuto-on25R2.2

With this release, the limits within the 5 Whys Analysis UI for both the number of Why trees per diagram and the number of Why items per tree increase from ten to 20. These expanded limits provide users with greater flexibility for more exploratory comprehensive analysis, particularly for complex issues.

QMS (QualityOne) & HSE

Expanded Print Record SupportAuto-on25R2.2

This feature introduces Print Record support for the following QualityOne features:

• Auditor Profiles & Qualifications
• Comments
• Inspections

This enhancement improves the completeness and legibility of the data in downloaded PDFs in cases where application controls are used to display data, images, and special characters.

Audit Report Printable View: Accessibility EnhancementsAuto-on25R2.2

This feature introduces accessibility enhancements to the Audit Report Printable View, including Alt Text and additional keyboard shortcuts. These enhancements improve the user experience for users that utilize keyboard navigation and screen readers.

RegulatoryOne

Registration & Dossier Management

Specify Type for Local Impact Assessment Lifecycle RulesConfiguration25R2.2

This feature extends the Local Impact Assessment Enhancement: Ignore Cancelled & Withdrawn Objectives functionality delivered in 24R3 so that Registration & Dossier Management users can reuse an approved Registration when conducting a Local Impact Assessment, while avoiding any expired Registrations.

Compliance Management & Registration & Dossier Management

Display Full Text Values in ViewersAuto-on25R2.2

This feature enhances the Requirement Hierarchy Viewer and Registration Item Viewer in Registration & Dossier Management Vaults and the Formulation Composition Viewer in Compliance Management Vaults. Users can now hover over truncated text displayed in the viewers to view the entire value before selecting records.

Veeva Claims

Veeva Claims

Assign Available Claims: Copy Related RecordsAuto-on25R2.2

This feature enables users to copy Local Adaptations and Substantiations to Claims created when assigning available Claims related to a Product when running the Assign Available Claims action, significantly reducing the number of clicks needed to copy existing Local Adaptations and Substantiations.

Enhanced Substantiation Document Panel with Supported Local AdaptationsAuto-on25R2.2

This feature enhances the Substantiation Doc Info panel so users can view and directly access all Local Adaptations supported by the substantiation document.