New in 26R3 Limited Release

Limited Release Dates: August 21, 2026 (26R2.2); October 2, 2026 (26R2.3); October 16, 2026 (26R2.4) | General Release Date: December 4, 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

Admin Configurable Entry Criteria Validation MessagesConfiguration26R2.2

To provide a better user experience for entry criteria on document and object lifecycles, Admins can now configure an optional Validation Error Message for each rule with up to 500 characters. When no custom validation message is configured, the default system error message is returned.

Additionally, we have made enhancements to the default system messages:

Document Entry Criteria

• Messages will list the affected documents in the new Document ID: {ID} v{major version}.{minor version} format (for example, Document ID: 701 v0.2)
• Messages where there is no Field validation will no longer display the Edit Fields button, and will display OK instead.

Object Entry Criteria

• Messages will display the complete list of each entry criteria validation failure.

Managing Documents

Create Incomplete Documents via Drag and Drop into LibraryAuto-on26R2.2

Users can now create Unclassified documents in the Incomplete state by dragging and dropping documents from their desktop into the Library tab or other custom document tab:

This creates the documents in the Incomplete state and adds them to the Document Inbox. This allows users to upload more content more quickly and easily. Prior to 26R3, this drag-and-drop option was only available directly within the Document Inbox.

Learn more about Incomplete Documents.

Analytics

Process Graph Full-Screen & ExportAuto-on26R2.2

When working with the Process Graph, users can now make graphs full screen and easily export graphs as image files.

Viewing a graph in full screen makes it easier for users to navigate more complex process variants:

Being able to easily export Process Graphs as images supports users who may need to include these visualizations in presentations or sharing with others within the organization.

Learn more about Process Monitor.

Drill Down from Metrics & ChartsAuto-on26R2.2

Users can now drill down into specific records or documents from metrics and charts in Process Views, making it easier to dive into details when assessing process efficiency in Process Monitor.

For instance, when looking at the Cycle Time Distribution chart, a user could easily click in to see more information about the outliers represented by the point on the chart:

This ability applies to standard and custom charts, as well as the following metrics that may be displayed at the top of a Process View:

• First Time Right (Total and %)
• Total with Rework
• Completed Late (Total and %)
• Completed Ontime (Total and %)
• 1st Quartile
• 3rd Quartile
• Entered End State
• Entered Start State

Learn more about Process Monitor.

Reorder Objects in Reports with Multiple Down ObjectsAuto-on26R2.2

For reports that contain more than one down object, report editors can now reorder the objects with their columns when editing reports, providing more flexibility in formatting for more complex reports.

In the example below, this report type for the Account object contains two down objects: Contracts and Goals.

These related objects are now displayed in the order in which they were added, and when editing a report based on this report type, users can select the object headings and reorder them:

Admin Experience

Filter Admin Audit by Document Number and Record IDAuto-on26R2.2

Admins can now filter the Document Audit History log and Object Record Audit History log for specific lists of documents or records using new Document Number, Document ID, and Record ID filters.

This makes it easier for audit trail reviews to occur based on specific records, without needing to pull each record’s audit trail individually, or to filter through more information than needed.

Users can paste up to 1,000 values copied from a spreadsheet.

Learn more about Viewing Admin Logs.

Custom Margin Sizes for Overlay TemplatesAuto-on26R2.2

When creating or editing overlay templates, Admins can now specify margin sizes, making it easier to create precise templates that align with business formatting needs.

The size is set in points, which is a universal unit commonly used for typography and printing, equivalent to 1/72 of an inch. The default values are 54 points for each margin, which ensures parity with current margin sizes.

Learn more about Managing Overlays.

Minor Enhancements

Grouping ID in Audit ExportsAuto-on26R2.2

When exporting audit trails from Vault to CSV, the export files now include a Grouping ID column. This allows users to identify updates that occurred as part of a single action (sharing a Grouping ID value).

In this example, several changes that occurred on a given document as a result of reclassification, all with the same Grouping ID value:

Prior to 26R3, this was only available when using the Vault API to retrieve the audit history for a single object record. This feature applies the Grouping ID column to all document and object record audit exports, in both the API and the user interface.

Learn more about Viewing Audit Trails and Viewing Admin Logs.

User Role Limit IncreaseAuto-on26R2.2

Admins can now add up to 100 user roles to a single user. Prior to 26R3, this was limited to 50 user roles per user.

Learn more about Managing Permissions with User Roles.

Respect Page Size for HTML FilesAuto-on26R2.2

When rendering HTML files that have a page size defined in the HTML, Vault now respects the page size in the generated PDF viewable rendition.

Common Data Architecture: Updates to Language and Country PicklistsAuto-on26R2.2

The standard Country (country_cda__v) and Language (language_cda__v) Picklists now include the following updates:

• Country
  • Great Britain has been updated to United Kingdom
• Language
  • New values added:
    • Armenian
    • Kyrgyz
    • Indonesian
  • Filipino has been updated to Tagalog

Veeva Connections

Clinical Operations-EDC Connection

Clinical Operations-EDC Connection: Site PI AssignmentsConfiguration26R2.2

This feature enhances the Clinical Operations-EDC Connection to automatically transfer Principal Investigator (PI) records and PI site assignments from CTMS Vaults to EDC Vaults. By establishing a single source of truth, this automation eliminates duplicate manual data entry, reduces reconciliation errors, and simplifies downstream data usage such as safety reporting.

When you assign a PI to a Study Site’s Principal Investigator field in CTMS, their core details first name, last name, email, language, locale, and timezone are automatically transferred to create or update a corresponding Person record in EDC. Vault links Person records by populating the Link field in EDC with the record’s Global ID from CTMS.

As part of the Site Integration data transfer, EDC automatically updates the Site’s Primary Contact field with a reference to the transferred PI record. Person records created or updated via the Connection are designated as CTMS-managed in EDC and cannot be edited, inactivated, or merged. In Veeva CTMS, the Merge Persons action is blocked if the losing Person record is actively assigned as a PI on a connected Study Site.

This feature is delivered inactive.

Learn more about other new Clinical Operations features below.

PromoMats-CRM Connection

PromoMats-CRM Connection: Event Management Metadata Sync EnhancementConfiguration26R2.2

Sync objects and picklists now support Approved Email transferring CRM Event Management content. The PromoMats-CRM Connection transfers Event Topic and Event Type metadata from Vault CRM to PromoMats Vaults. The metadata is stored as records or picklist entries available for users to associate a document with specific events.

Learn more about other new Commercial features below.

Medical-CRM Connection

Medical-CRM Connection: Event Management Metadata Sync EnhancementConfiguration26R2.2

Sync objects and picklists now support Approved Email transferring CRM Event Management content. The Medical-CRM Connection transfers Event Topic and Event Type metadata from Vault CRM to Medical Vaults. The metadata is stored as records or picklist entries available for users to associate a document with specific events.

Learn more about other new Medical features below.

Study Training-Clinical Operations

Study Training-Clinical Operations Connection: Merge Person Enhancements for Study Training UsersConfiguration26R2.2

This feature introduces foundational backend support for merging Person records in Clinical Operations, eliminating previous system roadblocks that prevented merges whenever a Person was related to a Study Person on a study connected to Vault Study Training.

This initial implementation provides essential functionality, with further refinements planned for subsequent releases.

When duplicate Person records are merged within Clinical Operations, the Study Training-Clinical Operations Connection synchronizes the event to Study Training. A background worker job logs the transaction in a new Person Merge History object record, marks the duplicate Person record as deprecated, and links it to the surviving profile.

This deprecation safeguards compliance by preventing future automated assignment logic and canceling any open Training Assignments to eliminate accidental training generation. To achieve full data consolidation, Vault Admins must perform manual cleanup steps to merge historical training completions, update document Sharing Settings, and inactivate the deprecated User account.

Learn more about other new Clinical Operations: Study Training features below.

Clinical Operations

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

All Clinical Operations Applications

Address Type EnhancementsAuto-on26R2.2

To standardize tracking and improve data consistency for imaging and radiology facilities, the Address Type (address_type__v) picklist now includes a standard Imaging Location value, added as Active by default. This is fully compatible with Site Connect, enabling site users to create or reuse Imaging Location addresses when managing Site Address records and completing the Form FDA 1572.

Additionally, the Address Type field is now available on the Location object in an Inactive status. Once activated by an Admin, this enables the Address Type to be automatically populated on Location records created by utilizing the Create Location from Address action on Study Site Addresses.

Word Formatted Output: Support Document Field Mapping in Object Action and Job ConfigurationAuto-on26R2.2

To provide administrators with greater control over document field population during document generation, Vault now supports granular field mapping for Word Formatted Outputs configured through object actions and job steps. Previously, system-level rules automatically copied object fields to all available document fields. Administrators can now specify which active document fields are populated from the source object. If no specific fields are selected, Vault falls back to standard default mapping behavior.

CTMS

User Action and Bulk Action for Copy Study SDR Plan Available for Study SitesConfiguration26R2.2

During clinical trial planning and setup, organizations frequently deploy standardized Source Data Review (SDR) plans across various sites to maintain compliance and consistency. Prior to this feature, users had to manually create SDR Plans for each individual site when they wanted to apply an existing SDR plan to multiple active sites. This repetitive, time-consuming process was inefficient and prone to manual error. 

This new feature introduces a user action and a new bulk action to Copy Study SDR Plan, which facilitates the rapid and accurate deployment of SDR plans across multiple sites.This allows the execution of copying SDR plans to multiple sites simultaneously, or on an individual basis. 

This enhancement removes the inefficiency of manual, one-by-one copying and guarantees the consistent implementation of monitoring strategies across a trial portfolio, ultimately streamlining study setup and improving overall operational oversight.

Automated Forecast Roll-up for Metrics Over TimeAuto-on26R2.2

Streamlining recruitment planning and enrollment metrics tracking, this feature introduces a new Forecasted Roll Up field on the Metrics object that behaves identically to the existing Planned Roll Up field. The Forecasted Roll Up field shows the sum of the number of subjects forecasted in the Metrics Over Time records. 

When a Forecast value is added, updated, or deleted on a Metric Over Time record, Vault automatically recalculates and sums these values to the parent Metrics record. These values also roll up through the clinical hierarchy, Site > Country > Study, so that aggregate forecast recruitment data can be accurately tracked across the study without manual actions. For complex study designs using Subject Groups, forecast data aggregates accurately within the assigned group. 

By eliminating manual data calculations, this feature provides study teams with immediate visibility into metric forecasting, reducing reconciliation errors and improving oversight.

Clinical Global Directory Merge Enhancements: History TrackingAuto-on26R2.2

In Clinical Operations, maintaining accurate Global Directory records, including Persons, Organizations, and Locations, is essential for effective study administration and data integrity. However, duplicate records are routinely generated in clinical environments due to decentralized operations running multiple workflows or manual data entry errors. For effective and accurate data quality management, industry standards require cleaning up these redundant records while enforcing strict guardrails to prevent accidental merging or deletion of protected identities, all while maintaining a complete, persistent audit trail. 

To facilitate data cleanup, Vault provides native record consolidation capabilities including dedicated Clinical Merge actions for Person records, alongside Platform Merge tools across other Global Directory entities (Persons, Organizations, Locations, and Contact Information). Prior to this change, executing data cleaning activities using these tools presented key operational and technical challenges. When utilizing Clinical Person merge tools, system validation rules restricted merges whenever a duplicate Person record was associated with Study Training. Additionally, because duplicate records are permanently deleted upon merge completion across all Global Directory objects, historical context was lost during cleanup, compromising the granular audit trail required for compliance and downstream reconciliation (such as Veeva ID tracking).

This new feature introduces the following improvements:

• Study Training Unblocking: The system updates merge validation rules to allow merges involving duplicate Person records associated with Study Training, removing previous operational blockers.

• Automated Audit Tracking: Upon successful reference repointing, attachment migration, and deletion of the duplicate record, the system automatically creates a persistent tracking record in the new Global Directory Merge History object. During this process, the system automatically links the main record (Person, Organization, Location, or Contact Information) and populates key audit details from the deleted record, including its duplicate identifiers, initiating user, completion timestamp, and cross-referenced Job ID. 

This enhancement eliminates the risk of data corruption from merges, streamlines administrative workflows for Study Training, and guarantees the complete historical visibility required for data quality management and compliance.

Previous Monitoring Event Refinements: Ignore Inactive Records & Records Without Actual DatesAuto-on26R2.2

This feature refines the logic for evaluating Previous Monitoring Events. Vault now automatically excludes inactive records and events that lack actual dates when establishing previous monitoring event references. 

This update includes: 

• Exclusion of Inactive Records: The system now ignores inactive Monitoring Event records as well as active Monitoring Events linked to inactive Milestones. If a Monitoring Event or its related Milestone is set to inactive, it is automatically removed from consideration and replaced with an eligible active record. 

• Actual Visit End Date Requirement: To be eligible as a Previous Monitoring Event, a record must have an Actual Visit End Date. Monitoring Events with only planned dates are now excluded. 

This update applies to the Previous Monitoring Event, Previous Blinded Monitoring Event, and Previous Unblinded Monitoring Event fields. Any existing references to ineligible records will be automatically updated to an eligible record when the Previous Monitoring Event logic is triggered. 

By ensuring only completed, active Monitoring Events are linked, these enhancements eliminate unexpected data seeding and improve overall accuracy.

Auto-populate Open FUI and Open Issues for Trip Report Question ResponsesConfiguration26R2.2

This enhancement adds a new Pull Forward Open Issues and Follow-Up Items setting to the Seed Trip Report Question Responses system action. When enabled, Vault automatically generates new Response Issue or Response Follow Up Item join records, linking open items directly to the seeded Trip Report Question Responses in the new Monitoring Event when they were previously referenced in Trip Report Question Responses. 

This feature improves visibility into unresolved items and streamlines trip report completion, ensuring records are not overlooked between visits.

CTMS, eTMF

Clinical Homepages Enhancements: AccessibilityAuto-on26R2.2

Providing an accessible user interface is essential to ensure all clinical personnel, including those relying on screen readers or touch-screen devices, can seamlessly navigate operational views. This update aligns key clinical homepages (including the TMF Homepage, CRA Homepage, and Study Management Homepage) with Web Content Accessibility Guidelines (WCAG).

Key enhancements included in this release:

• Descriptive Filter & Field Labels: Added standard screen reader labels (aria-label) to key dropdown selectors, including Study, Study Country, Site, Milestone Category, and Quality Issues status filters, enabling screen readers to clearly announce each control without altering visual page design.
• Action Button Labels: Added accessibility titles and labels to ellipsis action buttons across the CRA and Study Management homepages so screen reader users can identify contextual menus.
• Improved Color Contrast: Updated text colors and warning highlights (refining gray #555555 and orange #D47C0A to compliant shades like #CC6600) to increase visual contrast and readability for low-vision users.
• Larger Touch Targets: Increased the size and spacing of interactive buttons to a minimum of 24 pixels, making controls significantly easier to tap on mobile and touch-screen devices.

This enhancement removes critical usability barriers and ensures an inclusive, reliable experience for all clinical users across devices.

CTMS, eTMF, Study Startup

Study Level EDL Overrides Based on Study CountriesAuto-on26R2.2

When a study-level Template EDL includes a country-specific override designed to add study-level milestone types, Vault will now conditionally apply those milestone types. The milestone types will only be added if an active Study Country exists for that specific country. This enhancement prevents the unnecessary linking of Expected Documents to study-level Milestones for clinical trials participating in limited regions, reducing administrative overhead.

This feature is Auto-On for all Vaults utilizing study-level EDL Template Overrides.

OpenData Clinical

Prevent Linking OpenData Clinical Investigator to Non-VeevaID UserAuto-on26R2.2

OpenData Clinical now exclusively supports linking VeevaID site users to OpenData Clinical Investigators to streamline identity management and reduce complexity. System triggers now prevent non-VeevaID site users from being linked to mastered OpenData Clinical records via Vault UI, API, and Vault Loader. The system now prevents both associating non-VeevaID users to mapped OpenData Clinical records and adding an OpenData ID to Investigators linked to non-VeevaID users.

Data Change Request Hyperlink in Resolution NotificationAuto-on26R2.2

Notifications sent upon the resolution of a Data Change Request (DCR) now include a direct hyperlink to the specific DCR record in Vault. This enhancement streamlines navigation, allowing users to quickly navigate to review resolution details and data updates without manually searching for the record.

Site Connect

Document FilteringAuto-on26R2.2

Users can now filter by Document Type across applicable tabs within the Document Exchange and Payment Information sections of Site Home. This will allow users to quickly narrow down exchanged files using multi-selection as well as search within the filter.

Distribute PDFs to SitesConfiguration26R2.2

This feature provides a new application setting, Distribute Viewable Rendition. When an administrator enables this setting, documents exchanged via Site Connect with an Expected Action of None will distribute the Viewable Rendition rather than the Source File. This behavior applies only to the following document formats:

• Microsoft Word
• Microsoft PowerPoint
• Text 

Additionally, if these documents are filed to SiteVault, the Viewable Rendition is filed rather than the Source File. 

If a Site Rendition exists, that rendition will be exchanged or filed rather than the Viewable Rendition. Administrators can enable this setting by navigating to Admin > Settings > Application Settings > Connected Studies. If left disabled, system behavior remains unchanged.

Cancel Distribution Tasks when Recalled or Not RequiredAuto-on26R2.2

To prevent unnecessary site effort and reduce confusion, Vault now automatically cancels open Document Actions when:

• Recalled Document: Open Revise & Return tasks are automatically moved to the Cancelled state and removed from the Site’s Document Actions tab. 
• Requiredness Updated to Not Required on Expected Documents: Open Provide Original tasks related to that Expected Document are automatically moved to the Cancelled state and removed from the Site’s Document Actions tab.

Recall Notification for Safety RecipientsAuto-on26R2.2

To ensure relevant Site Connect users are informed of safety letter updates, Vault now sends recall notifications to users assigned the Assess Safety Notifications (Primary or Secondary) responsibility, even if they do not hold the Maintain Essential Documents responsibility.

Conditional Auto-Create for Safety DistributionAuto-on26R2.2

Automatic Safety Distribution has been enhanced so that the auto creation of a Safety Distribution record will be bypassed if no Study on the document is set up to use Safety Distribution. To do this, Vault checks that at least one tagged study is configured with a Connected Study Type containing Safety Distribution before generating the record.

Site Home User Interface ImprovementsAuto-on26R2.2

This feature introduces user interface enhancements across Site Home to streamline navigation and improve information visibility for sites:

• Column Layout Optimization: The Sponsor/CRO Comments field has been moved directly to the right of the document name in the Received tabs of both the Document Exchange and Payment Information sections, making contextual notes faster and easier for sites to read.
• Exclusion of Obsolete and Deleted Documents: Document grids across Site Home now fully restrict access or actions from being taken on documents that have been hard-deleted or are associated with an Obsolete or Deleted state type. This update applies across the Document Exchange section, Safety Distribution section, Payment Information section, and End-of-Study Media section.
• Focused View for Study Announcements: When a user logs into Site Connect from an announcement email or clicks an in-app announcement notification link, Vault now opens a focused view displaying only that specific announcement allowing users to immediately review relevant details without distraction. A Show All button is also available to easily return to the full list of announcements.

Update Doc Fields on Distribution Task on Classify/ReclassifiedAuto-on26R2.2

When you classify or reclassify a document linked to a distribution, Vault now automatically updates the Document Type, Document Number, and Site Document Type fields on the associated Distribution Task to reflect the latest document metadata.

Cloning Enabled for Safety Distribution Default Mapping ObjectAuto-on26R2.2

Safety Distribution Default Mapping records are now classified as configuration data so that they will be included when cloning a Vault.

Edit Comments and Due Date on Distribution TaskAuto-on26R2.2

Users with edit permissions on Distribution Tasks can now edit the Due Date and Sent Comments directly within the Document Exchange tab as well as edit Sent Comments within the Document Exchange sections on Study Sites and Milestones.

Site Connect, Study Startup

USN Modal EnhancementsAuto-on26R2.2

This enhancement updates the terminology and messaging sites see when interacting with Universal Site Number (USN) entry modals, search and sign-up dialogs, FAQs, and related notifications. This update replaces more technical terminology with user friendly language and provides sites with clearer context on how entering a USN allows them to easily re-use standard survey answers and store Study Site Addresses.

Study Startup

Feasibility Homepage: Survey ResultsConfiguration26R2.2

Feasibility surveys are a critical driver in determining whether a site is a good fit for a clinical trial, especially when a Sponsor or CRO has not worked with a specific institution. Without a streamlined, interactive view, Feasibility Managers face significant risks of delays in identifying and qualifying the best sites for their trials.

The new Feasibility Homepage introduces a dedicated application page that allows users to dynamically filter and assess site feasibility data. This feature functions as follows:

• The user applies required page-level filters for a Study or Outreach Campaign and selects up to four Survey Type, such as Initial Interest with eCDA, Initial Interest without eCDA, Site Feasibility Survey, and Fast-Track Feasibility Survey.
• A structured table displays survey results and the user can scroll through and expand or collapse detailed survey sections and questions.
• The system uses visual indicators, such as color-coded Response Flags, including High, Medium, and Low tiers or Electronic Confidentiality Confirmed, to highlight key information instantly.
• An advanced filtering modal supports specific criteria for multiple-choice, date, or number questions, automatically highlighting corresponding answers in the table. This modal supports filtering across survey types to support analyzing across surveys, such as Initial Interest with eCDA and Site Feasibility Survey.
• Users can execute site-specific or bulk action, such as Select Site, Reject Site, or Send Survey, directly from the table.

Custom Email Sender CC/BCC ExtensionAuto-on26R2.2

Custom Email Sender supports defining which emails a survey should be sent from and those who should be copied. This extension feature reduces manual effort by supporting the copy functionality at a higher level for Site or Outreach Target Surveys. Copied individuals can now be defined at the Study Country or Study level for Site Surveys, while copied individuals can be defined at the Outreach Campaign level for Outreach Target Surveys. In doing so, all Site or Outreach Target Surveys that exist within a Study Country/Study, or Outreach Campaign, will include the copied email, respectively.

Study Training

Matrix Control Center: Training Requirement Auto-NamingConfiguration26R2.2

Today, when documents are synchronized from Clinical Operations, auto-created Training Requirement names default to Clinical document names, which are often cryptic or unintuitive for Learners.

To address this, we are introducing automated Training Requirement naming, which sets the foundation for the broader Matrix Control Center. 

Vault Admins can now configure Vault-wide rules to dynamically control Training Requirement record naming based on up to three document fields of supported field types (Picklist, Date, or Text). Admins can optionally append the system document version to the generated name.

To ensure seamless record generation, missing metadata is automatically skipped, and Vault falls back to the standard Clinical Operations document name when all configured fields are empty.

By enforcing standardized naming conventions, this enhancement ensures Learners receive clear, context-rich assignments on their Learner Homepage rather than raw clinical file names, improving overall clarity and comprehension.

Learner Exemption Request: Study ContextConfiguration26R2.2

To ensure Learner Exemption Requests are reviewed by the appropriate personnel, this feature introduces study-level metadata to exemption requests. This allows Vault to route review tasks directly to the responsible study team members (such as CRAs) based on matching study, country, or site data. 

When a Learner Exemption Request is created, Learners are prompted to enter optional Study, Study Country, and Study Site fields. These fields display pre-filtered options showing only the study paths associated with the Learner’s Training Assignments. For non-study specific training (such as LearnGCP), Vault sets a new Non-Study Specific field so that the request can be routed to a non-study specific reviewer.

By adding study context to exemption verifications, this feature enables targeted review by the appropriate study personnel, improving security and accelerating the review process.

eCOA

Studio

Automated Audit Trail ExportsAuto-On26R2.2

Sponsor/CRO Staff can now automate an FTP connection to export site audit trails. Options for Site Clinical, Site Non-Clinical, and Studio and Study Home reports will be included. Users can also choose to include a log file with the export.

Library Manager

Library Viewer RoleAuto-On26R2.2

Sponsor/CRO Staff can now access a read-only view of the survey library. Administrators can assign the new Library Viewer role in Vault to grant users access to the Library Manager tab to see only published versions of surveys.

eCOA (Sites)

Improved Visibility for Sequenced and Training SurveysAuto-On26R2.2

Site Staff can now access the Start In Person button on events with available surveys, even when a sequenced survey on another event blocks those surveys. Additionally, available training surveys now are displayed in the To Do list during an in-person session, and under the Today bar when a participant logs into the application. This helps users quickly identify that training surveys are available, especially if they block other pending surveys.

Commercial

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

PromoMats

MLR: Standard "Created From" ReportsAuto-on26R2.2

This feature provides a standard report: Materials with Expiring Created From Documents. We recommend that Admins create a custom copy of the standard report, adjust filters if desired, and schedule a Flash Report to send a notification to source document owners that link to an expiring target document.

Claims: Auto-Linking Matching EnhancementsAuto-on26R2.2

Auto-Linking now considers the Indication/Disease field on a document when filtering the Text Asset Library for eligible Claims to link. When a document carries one or more indication values, only Claims whose Indication/Disease field matches at least one of those values or is blank will be surfaced as candidates for linking. Documents with no indication specified remain unrestricted, allowing all Claims to be evaluated regardless of their indication value. This same logic has been applied when matching for Product Family, Product Form, and Product Variant fields, so that the document matches with Claims whose corresponding values are blank.

Additionally, Country matching has expanded to account for regional hierarchies, so that documents with a specific country will now match Claims assigned to broader parent regions. As an example, a document set to France will automatically pull in Claims tagged as EU, Global, or any region that lists France in its Included Countries (country_cda__v) field. To have a Country record represent a region and add multiple countries to it, be sure to select the Allow user to select multiple values checkbox in the field first.

Reviewer Queue EnhancementsAuto-on26R2.2

In this release we made a selection of small enhancements to Reviewer Queue, including defaulting to the current period rather than the last viewed period, respecting the Vault date format setting, and ordering tasks by due date when they have the same priority score.

eCTD Submission Ready Copies File Name ExclusionsAuto-on26R2.2

The functionality to remove unsupported characters from eCTD Compliance Packages is expanded to remove diacritics from characters and remove all characters defined as spaces, special characters, non-English letters, and other non-alphanumeric symbols. The characters included in the eCTD Submission Ready document names are limited to alphanumeric characters, underscores, and hyphens.

Modular Content: Standard Report for Documents Added to Content ModulesAuto-on26R2.2

Vault now provides a new standard report, Documents Added to Content Modules, enabling users to track document usage across Content Modules and identify where specific components are being used. This auto-on feature is available to all users immediately after release, with the underlying Report Types and Report Views also accessible to Admins for further customization. We recommend that Admins create a custom copy of the standard report and adjust the filters and layout as desired.

Multichannel

PromoMats: Support for Links in Multi-Slide PDF and MS Word CLM PresentationsAuto-on26R2.2

This feature introduces link support for Multi-Slide PDF and Microsoft Word CLM presentations. By automatically converting PDF and Microsoft Word hyperlinks into actionable CLM navigation elements during presentation creation, field representatives will be able seamlessly skip to specific slides and open external reference URLs all while capturing individual slide analytics.

Medical

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

MedComms

Medical: Standard "Created From" ReportsAuto-on26R2.2

This feature provides a standard report: Materials with Expiring Created From Documents. We recommended that Admins create a custom copy of the standard report, adjust filters if desired, and schedule a Flash Report to send a notification to source document owners that link to an expiring target document.

Scientific Statements: Auto-Linking Matching EnhancementsAuto-on26R2.2

Auto-Linking now considers the Indication/Disease field on a document when filtering the Scientific Statement Library for eligible Statements to link. When a document carries one or more indication values, only Statements whose Indication/Disease field matches at least one of those values or is blank will be surfaced as candidates for linking. Documents with no indication specified remain unrestricted, allowing all Statements to be evaluated regardless of their indication value.

Additionally, Country matching has expanded to account for regional hierarchies, meaning documents with a specific country will now match Statements assigned to broader parent regions. As an example, a document set to France will automatically pull in Statements tagged as EU, Global, or any region that lists France in its Included Countries (country_cda__v) field. To have a Country record represent a region and add multiple countries to it, be sure to select the Allow user to select multiple values checkbox in the field first.

Scientific Statements: Auto-Linking Settings EnhancementsAuto-on26R2.2

This enhancement for Auto-Linking Settings configuration extends the functionality to trigger Auto-Linking automatically when a document moves into a configured lifecycle state.

Content SimilarityConfiguration26R2.2

This feature introduces Content Similarity functionality to MedComms, facilitating a more efficient review of medical content. Previously added in PromoMats, these capabilities for MedComms include generating a similarity score for two related documents and the document compare action highlighting the differences between the documents. 

MedComms, MedInquiry, Publications

Team Security ManagementConfiguration26R2.2

The creation and management of User Role Setup records, User Role records, and user-managed groups can now be automated in Vault Medical via the Team, Team Assignment, and Team Member objects. This streamlines the process of managing user access in Vault Medical applications.

With this feature, which was previously introduced in PromoMats, adding a Team Member to a Team automatically provides that user with the security template associated with their Team Assignment.

Reviewer QueueAuto-on26R2.2

With the Reviewer Queue UI for the Vault Medical Home tab, content reviewers will see their tasks organized in a more user-friendly way. The new view displays reviewer tasks in two-week increments, with interactive charts and filters providing enhanced visibility. Support for expedited tasks is also added through this feature.

MedInquiry

Telephony Support: Moveable Telephony WindowAuto-on26R2.2

Users can now drag and reposition the Telephony pop-up window and minimized dock anywhere across the Vault UI. This enhancement allows for unobstructed access to crucial on-screen elements, for example, filters and Case details, while maintaining an active telephony session. By using the drag handle on the top of the header, the window can be moved to float over all UI elements.

Rename OmniConnect to OmnichannelAuto-on26R2.2

To better reflect our expanding suite of engagement capabilities and align with industry-standard terminology, we have renamed OmniConnect to Omnichannel. This update ensures consistency, clarity, and a more unified experience across your Vault configuration.

As part of this enhancement, the Omnichannel terminology has been comprehensively updated across all relevant objects and fields, including their labels, descriptions, and Help content texts. API names remain unaffected.

Multichannel

Medical: Support for Links in Multi-Slide PDF and MS Word CLM PresentationsAuto-on26R2.2

This feature introduces link support for multi-slide PDF and Microsoft Word CLM presentations. By automatically converting PDF and Microsoft Word hyperlinks into actionable CLM navigation elements during presentation creation, field medical team members will be able to seamlessly skip to specific slides and open external reference URLs, all while capturing individual slide analytics.

Publications

Project BuilderAuto-on26R2.2

The new Project Builder feature streamlines your workflow by automatically creating project Work Items, such as Workstreams and Milestones, based on preconfigured templates. Admins can easily configure these templates and tag them with specific metadata, for example, Project Type or Document Type, to ensure that the system selects the correct framework upon project creation. 

To further reduce manual data entry, the feature automatically populates standard baseline dates for both the project and its Work Items using predefined durations and reference types like Start on or Submit by. Additionally, this feature utilizes a dedicated Template object model that allows Admins to clearly designate which specific Work Items represent the project’s official start, end, submission, and publication milestones.

Quality

Batch Release

Market Specific MaterialsAuto-on26R2.2

With this release, Markets can be associated directly with Materials so that a Market Ship decision can be constrained by the Material instead of the Disposition Plan.

Check InstructionsAuto-on26R2.2

Admins can now show user instructions for each Check on the Batch Release Execution page. Admins can configure Check Instructions by adding text to the Check Requirement Decision field and adding this field to the Check/Item grid layout in Pages > Batch Release Page > Batch Release Page Layout > Check Grid > Options > Fields.

Parent Market for Market-Ship ChecksConfiguration26R2.2

This feature introduces a new self-referencing Related Market/Country object that enables Markets and Countries to be related to each other. Relating countries can be valuable in Batch Release when evaluating market specific checks which will evaluate “parent” markets when making market ship decisions for “child” markets. For example, customers can track regulatory approvals against the European Union (EU) as a “parent” market which will be evaluated for all related countries in the EU.

QMS

Complaint Intake Follow-Up EvaluationConfiguration26R2.2

In complaint handling, critical safety and quality data is often delivered through follow-ups with an initial reporter or complainant and captured directly within Complaint Intake Follow-Up records. Previously, evaluating the downstream impact of newly received information across associated complaints required manual tracking and review coordination.

This release introduces automated assessment of Complaint Intake Follow-Ups to optimize how organizations process updates to Complaint Intake records. The automation ensures that critical safety information, which often arrives after promoting a Complaint Intake to one or more Complaints, receives immediate review to assess potential impact.

A new Follow-Up Evaluation process automates impact analysis and streamlines task assignments when new information is received. When users create a Complaint Intake Follow-Up on a Complaint Intake, Vault automatically generates Followup Evaluation records for each related, active Complaint (excluding those in a Cancelled state). Each new Followup Evaluation captures a point-in-time snapshot of the response details and date, instantly routing the evaluation task to the Complaint Owner (who can be assigned through Quality Teams or Dynamic Access Control). This process is also triggered when updates are made to existing Complaint Intake Follow-Ups.

The Followup Evaluation Type field on Complaint Intake Follow-Ups allows users to indicate whether an impact assessment is required. Selecting No Impact allows users to bypass automated record creation for routine updates, such as typo corrections, while selecting Followup Evaluation Needed initiates the automated evaluation process.

This feature requires configuration by an Admin. Note that Quality Event: Complaint and MedTech Complaint object types are not supported.

Promote to Complaint: Promote Specific ProductsConfiguration26R2.2

The Promote to Complaint functionality helps organizations triage and transition quality complaints from an initial Complaint Intake into Complaint records. In some cases, a Complaint Intake may include more reported products than necessary for complaint processing, which can complicate and slow down the triage process.

Users can now choose to promote only a specific subset of products included in the initial Complaint Intake using a new Do Not Promote checkbox field on the Reported Product object.

When a user executes the Promote to Complaint action on a Complaint Intake record, Vault now skips all Reported Products with the Do Not Promote checkbox selected, generating Complaint records only for the remaining products.

Preventing unnecessary or irrelevant Complaint records from being generated allows organizations to maintain cleaner quality data and optimize downstream processing efficiency.

The new Do Not Promote field is provisioned as Inactive with a default value set to No, and requires configuration by an Admin.

QRM: Capture Inactive Values in Assessment History RecordsAuto-on26R2.2

The Periodic Risk Review feature allows customers to capture a point-in-time snapshot of a Risk Assessment when it is approved, preserving the state of the Assessment and each of its Risk records for traceability and compliance reporting.

This release enhances the feature by addressing a common system administration scenario that sometimes prevented creation of Assessment History records. Admins deactivate data referenced by Assessments, Risks, Risk Documents, and Risk Mitigations when that data represents information that should no longer be available for use. For example, an Admin might inactivate a picklist value assigned to a field on a Risk record that represents a manufacturing process that is no longer used. Similarly, an Admin might inactivate a record representing a vendor that is no longer used, so it cannot be selected in an Assessment.

Prior to this release, the process of generating an Assessment’s history fails when Vault encounters an inactive value. When this happens, Vault sends a notification to the Assessment record owner.

Most organizations configure the Periodic Risk Review feature to capture an Assessment’s history each time it is approved. The error does not block the Assessment’s approval, but it means the Assessment is approved without a history of the latest approved version. The workaround requires customers to identify inactive field values, reactivate them, re-run the action to capture an Assessment’s history, and then deactivate the values again. This is a time-consuming, error-prone, and risky process to temporarily restore values that were intentionally retired.

With this release, Vault now allows the Assessment history generation process to successfully capture deactivated values, eliminating errors caused by deactivated picklist values and referenced records.

The feature is automatically enabled in Vaults with the Periodic Review History feature configured for Assessments.

QRM: Capture Assessment History in a Workflow StepConfiguration26R2.2

The Periodic Risk Review feature allows customers to capture a point-in-time snapshot of a Risk Assessment upon approval, preserving the state of the Assessment and each of its Risk records for traceability and compliance reporting.

Prior to this release, Admins could only configure the Capture Assessment History action to generate an Assessment’s history when an Assessment record entered a particular state, typically the Approved state.

This feature gives Admins an additional configuration option to run the Capture Assessment History action from a system action step in a workflow. This is useful when your organization wants to:

• Ensure an Assessment’s history is fully generated before generating the Assessment’s formatted output document that includes references to the history records.
• Manually generate an Assessment’s history without changing the Assessment’s state.

To use this feature, an Admin must configure a workflow step to run the Capture Assessment History action.

Quality Team Locking During AssignmentAuto-on26R2.2

Prior to this release, multiple users attempting to simultaneously update a record’s Quality Team membership could result in issues such as duplicated role assignments in the record’s Sharing Settings, and execution of duplicate parallel workflows and task assignments.

This release introduces an enhanced locking process to prevent multiple users from simultaneously updating a record’s Quality Team, eliminating duplicate Sharing Setting and workflow task assignments. The first user to begin assigning roles on a record’s Quality Team triggers a lock on that record’s Quality Team. This prevents other users from updating the Quality Team at the same time. If a user attempts to save changes to a Quality Team that is already locked by another user, Vault now displays an error message like the one shown below.

This feature is automatically enabled in this release.

Surveillance

VPS: Health Authority Forms UpdatesAuto-on26R2.2

This feature enhances each of the health authority forms with several updates regarding data management.

eMDR Health Authority forms now render Country codes using 3 digits as opposed to the 2 digit system used in prior releases. Additionally, Vault now generates the Importer Report Number from section F2 automatically based on the Importer organization selected on the Adverse Event Report record.

EU MIR/UK MHRA smart contact blocks have received several updates to managing various Reporter information. The field for Role of Reporter - Other is now dynamically displayed (and included in the XML/PDF renditions) only when the Role of Report is set to Other. Relatedly, both health authority forms now validate that a Role of Initial Reporter has been captured. Lastly, for these two health authority forms’ smart contact blocks, in sections A2/A3 validations have been added to ensure that either the AER_type_of_report_urgency__v is set to Final or set to Update with Reporter Contact Information also present.

For PMDA health authority forms, the General Name Code message from the quality_surveillance__v message group has received a new translation value, and Periods of Use - Unit can now be correctly captured and rendered in the generated XML.

QualityDocs

Process Navigator: Document Association TypesAuto-on26R2.2

Process Owners in Process Navigator have the ability to associate documents to a process manually, as well as the ability to define Document Association Criteria rules to automatically associate documents to the process.

This feature adds a dedicated Association Type column to clearly distinguish whether a document was linked manually or automatically (“Manual” vs. “Auto”) directly within the Process Navigator side panel and process detail page.

This feature also includes a convenient export action on both the landing page side panel and detail view, allowing Process Owners to quickly download a complete, unified list of all associated documents—along with their association methods—to a CSV file.

The Association Type column and Export action are visible and available to users with Edit permission on the Visual Hierarchy and Hierarchy Document Association Rule objects.

Periodic Review Enhancement: Additional Auto-Start Periodic Review Workflow CriteriaConfiguration26R2.2

This feature provides expanded criteria for automated Periodic Review workflows, providing Admins greater control over when reviews initiate.

When configuring the Start Periodic Review Workflow as an entry action on a Periodic Review Lifecycle state, Admins can now select Do not start Periodic Review if the latest version is in the following state(s) and choose specific document lifecycle states.

In previous releases, if enabled, automated periodic reviews were launched regardless of the state of the latest document version. With this enhancement, the system will not initiate a new periodic review if the latest document version is in an excluded state.

This setting is only available when the Do not start periodic review if a later document version exists setting is disabled.

LIMS

Print Labels: Show User Input & Update Spark MessageAuto-on26R2.2

This feature enhances the Print Label action by showing the user a configurable form where they can enter additional information such as selecting a Print or entering a Reason. Additionally, each Print Label action now creates a Print Label Request record whose record ID is included in the spark message. Each Request record contains a reference to the source record where the Print Label action was performed, allowing for specific use cases such as tracking success or errors.

Exception Sections: Count of ExceptionsAuto-on26R2.2

The Exception Summary section now includes a count of exceptions, allowing users to quickly identify whether a given Sample, Test, or Spec Execution has exceptions.

Asset & Consumable Spec StandardizationConfiguration26R2.2

This feature introduces standard object types for Assets and Consumables across Spec Data, Spec Executions, and Lab Samples. Users can now use the Spec Data Builder UI to configure specifications for Assets and Consumables and automatically generate dedicated Asset and Consumable Lab Samples at runtime.

Stability Pull: Date/Time SupportAuto-on26R2.2

Stability Pull now supports pulls at the Hour or Minute mark.

Generate Document from Record: Workflow Job StepConfiguration26R2.2

This feature makes it possible to generate a document for an object record through a workflow job step. The workflow waits until the processing of the document is complete, allowing for Admins to manage failures in job creation directly within a workflow.

Retains Testing: Support Ad-hoc CriteriaConfiguration26R2.2

This feature allows Ad-hoc Criteria to be created from a Retains Testing Spec Execution record, which provides more flexibility when performing unscheduled testing.

Test Definition Builder: Add Hover Text for Fields in Variable ViewAuto-on26R2.2

In the Test Definition Builder, when viewing Variables, hovering over the value for Variable Type, Target Test Definition, Target, or Name shows the full value text.

Lab Study: Some Batches Cannot be UpdatedAuto-on26R2.2

On the Lab Study object, users can no longer update the Batch if at least one Spec Execution is initiated.

Trace ID is Now a Required FieldAuto-on26R2.2

Trace ID is now a required field on objects. Previously, it was not required, but always populated by code.

Label Definition Criteria VQL is EditableAuto-on26R2.2

The Label Definition field on Print Label User Input’s VQL criteria can be edited to include or exclude certain Label Definitions.

Stability Report: Configurable Timepoints per TableConfiguration26R2.2

This feature adds a new configurable input parameter to Report actions, allowing users to set a maximum number of Timepoints per table in the generated stability study report.

Prevent Test Definitions from Referencing Unusable ConstantsAuto-on26R2.2

This feature adds version verification checks to ensure that a Test Definition does not mistakenly reference an unusable constant as a variable.

SRE Tests Begin AsynchronouslyAuto-on26R2.2

This feature updates how Sample Result Entry Tests are started. Moving forward, the system updates the states of the Tests asynchronously, meaning that they move from the Not Started state to the In Progress state in the background without blocking the user from progressing to entering results. This is more consistent with the behavior of non-SRE Test Execution Tests and improves the performance and wait times to start SRE with a high number of Samples and Tests.

Stability Builder: Set Study or Study Design on Sample PlanAuto-on26R2.2

This feature adds Study and Study Design fields to the Sample Plan object.

Regulatory

RIM Submissions Archive

Edit Columns EnhancementsAuto-on26R2.2

The Edit Columns user experience in Submissions Archive Viewer now includes column groupings that align with the appearance of columns in the Viewer. Within the Select Columns to Display dialog, the Available Columns and Selected Columns modals include groupings for Archive Metadata, Submission, and Correspondence.

What’s New

When executing the Edit Columns action from Submissions Archive Viewer, users will see better alignment between the column selection modal and the appearance of columns in the Viewer. Previously, all available columns were selected from a single alpha-numeric list, even though the columns are arranged under separate groupings in the Viewer. With this new feature, the available columns are divided into their respective groups. Users can also arrange the order of column appearance within each group so the resulting Viewer appearance is accurately reflected in the column order.

Key Benefits

This feature aligns the column selection behavior of Submissions Archive Viewer with that of the Active Dossier and Content Plan Viewers. The new organization also improves the user experience of creating Saved Views and adding columns to the Viewer, improving its overall organization & usability.

RIM Registrations

Guided Event ActionsAuto-on26R2.2

What’s New

Guided Event Actions introduce dynamic, context-aware badges directly on Event record pages to guide users through end-to-end event management. This addresses a critical usability gap, especially for infrequent users, by helping them determine the appropriate sequence of actions to perform on an Event.

By evaluating record conditions in real time, these interactive badges serve as user-facing anchors that offer explicit guidance and in-line actions, such as launching the Create & Manage Event Details (CMED) or Update Local Regulatory Information (ULRI) wizards.

The following badges display at the section header level based on specific data triggers:

Section Header	Target Action(s)	Trigger Condition
Details	Create Event Details	The Event has no active change items and no active relationships.
Details	Update Local Regulatory Information (ULRI)	The Event meets standard criteria for local updates, AND there is at least one active item or relationship that has never been sent to impacted markets (and isn’t currently sitting in In Data Review).
Activities	Create Related Records (CRR) & Impact Assessment Report	The Event has active relationships or change items, BUT zero Activities, zero Regulatory Objectives, and zero Submissions.
Activities	Assess Local Activities	There is at least one related Activity sitting in a status that requires assessment (based on your system settings).
Regulatory Objectives	Create Related Records (CRR) & Impact Assessment Report	The Event has active items or relationships AND at least one Activity, BUT is still missing either Regulatory Objectives or Submissions (or both).
Global Content Plan	Create Global Content Plan (GCP)	The GCP field is blank and at least one relationship is flagged as Use for Content Plan = ‘Yes’.

Vault applies priority rules when multiple conditions are met within the same section or across related functions:

• ULRI vs. CRR: If conditions for both are met, Vault displays only CRR.
• ULRI vs. Create GCP: If conditions for both are met, Vault displays only ULRI.

Key Benefits

• Improved Process Compliance: Interactive badges highlight suggested next steps directly on the Event page, reducing skipped actions and downstream compliance risks.
• Simplified User Experience: Clear guidance helps infrequent users quickly identify and execute necessary bulk actions and wizards without manual analysis.
• Streamlined Operations: Automated identification of data gaps leads to increased data completeness early in the lifecycle and fewer data correction requests for Admins.

Additional Considerations

• Automatic Activation: This feature is Auto-On for all RIM Registrations Vaults and relies on existing RIM actions without requiring changes to the data model or enablement of any setting.
• No Asynchronous Automation: The feature does not create or update records asynchronously without direct user interaction. It strictly highlights process gaps and links to manual actions.
• Page Refresh Required: Badges evaluate display conditions when the Event page loads or refreshes. Changes made to an Event do not trigger automatic updates until you refresh the page.
• Conditional Visibility: Badges only display if the corresponding user action is configured for the Event’s current lifecycle state and all configured display conditions are met. They respect the existing conditions for the actions and wizards from the action UI menu.
• Security & Permissions: Badge visibility respects Atomic Security and permission sets. If your security profile lacks Execute permission for an underlying action, Vault suppresses the badge.
• Referenced Record Permissions: Vault does not consider the user’s permissions on the records referenced by the condition when evaluating whether a badge should display.
• Object Exclusivity: These badges are exclusive to the Event object.

Populate Packaging Field on Pack-Size RegistrationsAuto-on26R2.2

Vault now supports a new Packaging field on pack-level Registration records, enabling you to filter by packaging configuration within Manage Registered Details (MRD).

What’s New

• On Registration Creation: When you run Create Registrations, Vault automatically populates the Packaging field (packaging__v) on the Registration record (registration__rim) when the Registration Scope is set to Marketed Pack Size.
• On Registration Management: The Packaging field can now be added as a viewable column and filter criteria inside the Manage Registered Details (MRD) wizard grid, giving regulatory teams immediate visibility into specific packaging configurations.
• On Packaging Changes: To support replacing packaging on a pack-level registration when a new registration number is not required, a system trigger runs when you create a new Registered Packaging record to evaluate and update the parent Registration record’s Packaging field accordingly. Note: The trigger only runs when the parent Registration field is already populated.
• Extract Packaging Level Registrations Action: To ease the enrichment of existing Registration records, a new action in RIM Maintenance allows Admins to extract a CSV file for active, pack-level registrations with their proposed Packaging values. The extracted CSV includes the record’s ID, Name, Packaging, and Packaging Name. Admins can use these results to perform a bulk update via Vault Loader.

Key Benefits

• Enhanced Filtering in MRD: Filter Registration records directly by Packaging in Manage Registered Details (MRD), improving efficiency when managing Registrations with multiple packaging configurations.
• Automated Data Maintenance: Vault automatically captures the Packaging field during registration creation and updates it if the packaging changes without requiring a new registration number.
• Simplified Data Migration & Review: Admins can quickly extract active, pack-level registrations and proposed Packaging values into a downloadable CSV file for review and evaluation.

Additional Considerations

• Provisioning: Vault provisions the Packaging field (packaging__v) as inactive on the Registration object (registration__rim) for supported marketed object types (Marketed Drug Product Registration and Marketed Vet Drug Registration). Admins must activate the field, grant edit permissions to appropriate security profiles, and update page layouts and layout rules.
• Trigger on Registered Packaging: The trigger executes upon creation of a new Registered Packaging record when the parent Registration record has a populated Packaging value. The trigger does not execute when the field is empty.
• Extract Packaging Level Registrations Action: Vault populates proposed Packaging values using the related active Registered Packaging record. If a registration has multiple related Registered Packaging records, Vault uses the most recently created active record based on the creation date. If no active Registered Packaging records exist for a registration, Vault leaves the Packaging field blank in the extract and details the reason in the Errors column.

RIM Publishing, RIM Registrations

AS2 Gateway Profiles Require Sponsor Email AddressAuto-on26R2.2

What’s New

The Sponsor Email Address field is now a required field for all AS2 Gateway Profiles. Previously, the field was optional, but as it is a required value for the gateway to respond, the RIM field is now also required. This applies to all AS2 profiles, including integrations used by Publishing and Registrations.

When a profile is activated or updated, Vault prevents saving when the Sponsor Email Address is blank.

RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive

Health Authority Interactions: Edit Extracted RecordsAuto-on26R2.2

Users using the Health Authority Interaction (HAI) panel to extract Health Authority Questions (HAQs) and Commitments can now update existing record text directly from the document by modifying the related annotation highlight.

What’s New

A new Edit (pencil icon) button is available on individual HAQ and Commitment cards within the HAI panel. Clicking Edit places you into annotation mode and focuses on the existing highlighted text. You can then highlight any text in the document and click Save to update and replace the Full Question (full_question__v) or Full Commitment Text (full_commitment_text__v) field value.

Key Benefits

• In-Context Editing: Effortlessly update extracted HAQs and Commitments without leaving the document viewer.
• Improved Accuracy: Easily re-highlight text to replace full question or commitment values and maintain precise extraction records.

Additional Considerations

• Scope: You can only edit one HAQ or Commitment record at a time.
• Panel Filtering: The Edit button is available only when filtering the panel by Health Authority Questions or Commitments. It does not appear in the All Interactions view.
• Enablement: This feature is automatically enabled for all organizations using HAI extraction for users with Edit permission on HAQ or Commitment objects.

Health Authority Interaction Extraction: Support for Custom Document FieldsAuto-on26R2.2

This feature enables immediate adoption of Health Authority Question (HAQ) and Commitment extraction by significantly reducing the need for prior metadata migrations.

Before vs. What’s New

• Previously: Adopting Health Authority Interaction (HAI) extraction required a tedious metadata migration to map existing custom fields and relationship objects to Veeva standard:
  • Custom document fields (such as commitment__c) had to be migrated to standard fields (such as commitment__v).
  • Creation of standard relationship objects (like HA Question Reg Objective (health_authority_question_reg_objective__v)) required the use of standard document fields (such as regulatory_objectives__v).

What’s New:

Customers can now bypass these migrations. Vault natively supports custom document fields by dynamically falling back to alternative namespaces if a standard component is inactive.

Core Functionality

• Dynamic Field Fallback: When processing extractions, Vault automatically searches for active document fields sharing the same base name as the standard document field (such as commitment or regulatory_objectives), ignoring the namespace suffix (such as __v or __c).
• Namespace Prioritization: If multiple active fields exist with the same base name, Vault automatically prioritizes standard Veeva namespaces over custom ones.

Key Benefits

• Minimal or Zero Migration Effort: Unlocks immediate use of the HAI Extraction tool in all RIM environments.

Additional Considerations

• Enablement: Prior to enabling this feature, custom and standard document fields should be evaluated. Document Types containing both standard and custom versions of the same field (like regulatory_objectives__v and regulatory_objectives__c) are not supported. Reference Constraints on standard and custom document fields should also be reviewed, so that automatic field population does not fail.
• Field Type Requirement: Custom fallback document fields must be Object Reference fields pointing to the appropriate parent object when attempting to create standard relationship objects (like HA Question Reg Objective (health_authority_question_reg_objective__v)). Picklist fields are not supported.
• Multi-Select Field Handling: If a custom document field is a multi-select object reference field containing multiple values, Vault seamlessly generates a unique join record for each selected value—identical to standard behavior.
  • Example: If a correspondence document’s application__c field references both Application A and Application B, Vault automatically generates two separate HA Question Application join records upon extraction—one linked to Application A and another to Application B.
• Backward Compatibility: No impact on existing customers who are already using standard document fields.
• Enablement: Auto-on for any customer with HAI Extraction enabled.
• List of Components: Below is the complete list of fields where the base name must match:
  • Document Fields:
    • health_authority_question__v
    • commitment__v
    • regulatory_objectives__v
    • health_authority_meeting__v
    • product__v
    • application__v
    • submission__v

Safety

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

For SSL and AS2 certificate updates for your Safety Vault, see the Veeva Certificate Expiry Date Ranges and Frequently Asked Questions (FAQs).

Safety

Web Intake Form: Usability ImprovementsConfiguration26R2.2

With this release, Veeva Safety introduces several improvements to the Web Intake forms including:

• Google reCAPTCHA: The Google reCAPTCHA now displays in the language selected by the respondent.
• Expanded File Support: When configured, attachments now support PPT, PPTX, and PNG file formats.
• Updated Email Response Checkbox: The Email a copy of my response to (email address) checkbox now dynamically shows the recipient’s address after email entry on single-use forms, and it is automatically pre-checked for verified users on repeat-use forms.
• Country-Based Product Alias Filtering: When configured, Product Name field values automatically filter by Products associated with the Reporter Country or Event Country.

Potential Matches Page: FilteringConfiguration26R2.2

With this release, Veeva Safety introduces flexible result filters for the Possible Matches section and visual review tracking. Admins can also enable an Intake Setting to specify default category filters on page load. This enables users to quickly isolate the most relevant results for streamlined reviews.

Key updates include:

• Matching Category Filtering: Users can refine returned results in the Possible Matches section by matching categories, helping them to quickly isolate specific candidate criteria.
• Default Filter Application: When default category filters are defined by an Admin, Vault applies all selected filter options on page load, displaying the most relevant matches immediately.
• Visited Record Indicators: To help users track their review progress, all potential matches returned in the left panel default to an unvisited state of display, indicated by bolded record names, until selected for review.

Usability Improvements for Case Compare PagesAuto-on26R2.2

To optimize data review and reduce navigation friction when processing cases, Veeva Safety introduces key usability enhancements to the Case Compare Page used to display data on the Inbox Item to Case Compare and Case Version Compare pages. Managing follow-up data on large cases previously required repetitive vertical scrolling because section headers and pagination controls moved out of view. Users risked losing manual selections if they accidentally navigated away from the page, and case promotion actions could sometimes execute without confirmation.

Key enhancements include:

• Sticky Section Headers & Pagination Controls: As users scroll down the page, the page header minimizes while section headers and pagination controls stay pinned below it, eliminating the need to scroll back to the top to navigate sections or change pages.
• Auto-Collapsed New Child Records: New child record sections (records exist only on the incoming side) now default to a collapsed state on the Case Version Compare page, significantly shortening long pages and reducing visual clutter.

Follow-Up Questionnaires: Email Response HandlingConfiguration26R2.2

With this release, Veeva Safety introduces automated questionnaire reply tracking to streamline intake workflows. Outgoing follow-up questionnaire emails now allow Vault to detect, classify, and link incoming replies directly to the originating Case version. This eliminates manual reconciliation and ensures traceability.

Managing follow-up responses from case contacts is critical for maintaining complete and accurate case follow-up. Previously, when a contact replied to a follow-up questionnaire email, users had to manually review the incoming response and correlate the generated Inbox Item to its corresponding Case version. This manual process was time-consuming, introduced administrative friction, and increased the potential for matching errors.

Follow-Up Questionnaires: Rules-Based Content Data ModelConfiguration26R2.2

With this release, Veeva Safety introduces the necessary data model that enables dynamic content generation in documents sent to eligible reporters for solicited follow-up. This lays the foundation for features planned for a future release.

Multi-Study Product Selector: Usability ImprovementAuto-on26R2.2

With this release, Veeva Safety automatically deletes empty placeholder records when adding Study Products using the multi-product selector and introduces enhanced validation rules to ensure Inbox Items include required product details prior to promotion, streamlining case intake and improving data quality. 

Key updates include:

• Automatic Placeholder Deletion: When adding Study Products via the multi-study product selector, Vault marks the default placeholder product for deletion if users have not entered any custom data.
• Role-Based Action Visibility: The Specify Study Products action in the Products section is now visible in View mode based on application role security and displays only to users with Edit permission for the applicable Inbox Item lifecycle state.
• Error Messages: If you do not specify all required product details, Vault displays a section-level error dialog and highlights the Study Product Blinded Name field with an error message upon save or promotion.

Create FDA E2B R3 Validation Criteria: C.1.7Auto-on26R2.2

To prevent FDA submission rejections (NACKs) caused by unpopulated expedited criteria, Veeva Safety now includes a standard validation rule for FDA E2B(R3) ICSR transmissions. Previously, if neither the ICSR Transmission nor the Case record specified whether the case met local expedited criteria, Vault exported element C.1.7 (Does This Case Fulfill the Local Criteria for an Expedited Report?) with a nullFlavor (NI) value, which resulted in FDA FAERS and VAERS gateway rejections. Vault Safety now validates that element C.1.7 is populated prior to submission.

Key enhancements include:

• Submission Validation Rule: Vault evaluates element C.1.7 during submission validation for both FDA FAERS E2B (R3) and FDA VAERS E2B (R3) file formats.
• Rule Evaluation Hierarchy: Vault checks the Local Expedited Criteria field on the ICSR Transmission record. If blank, Vault then checks the Expedited field on the Case record.
• Validation Failure Safeguard: If both the Transmission-level and Case-level expedited fields are unpopulated, the validation check triggers a Fail result. This prevents the generation and export of invalid E2B messages containing nullFlavor values for element C.1.7.

PMDA Domestic Case Processing EfficienciesConfiguration26R2.2

To optimize Japan domestic Case processing, Veeva Safety now consolidates regional and global data on the global Case, providing complete visibility and execution of PMDA workflows for drug, device, and regenerative product cases. Previously, local domestic Case Processors had to navigate between the global Case and the Localized Case to manage regional data, input device codes, calculate local reportability, and generate PMDA submission documents.

Key enhancements to Japan domestic Cases include:

• Consolidated Regional Case Layout: A new Regional section for Case Product Registrations is integrated into the Case layout. In addition, the Japan Case Product Registration layout includes Local Reporting Details, Localized Case Assessments, and Localized Case Comments, eliminating context-switching.
• Localized Device & Regenerative Tracking: To support device and regenerative product processing, the Company Device and Company Product layouts on the Case now include the Localized Case Product Device Codes section, allowing users to view and edit local device terms, local codes, and patient health damage details.
• PMDA Automation Actions: Users can run PMDA-specific actions directly from the Case:
  • Calculate Japan Reportability: Sequentially retrieves reportable Case Product Registrations, evaluates regulatory obligations to determine local due dates, and generates Local Reporting Details records in a single step.
  • Retrieve Case Product Registration: Fetches and populates reportable Japan product registrations.
  • Generate Localized Case Documents: Initiates generation of Localized Case Documents for all documents and literature articles attached to the Case.
• Expanded Adverse Event Outcomes: Case Adverse Events now support long-text Outcome (Other) field entries. Vault maps values to the Localized Case Adverse Event.

FDA E2B Reporting: Device Follow-Up Type Export AlignmentAuto-on26R2.2

To ensure device follow-up information is accurately reflected in E2B submissions, Veeva Safety updates the population of the FDA.G.k.12.r.2.r (If follow-up, what type?) data element on FDA FAERS E2B(R3) and FDA VAERS E2B(R3) files. In addition to case-level evaluations, Vault now also evaluates product-level device follow-up information. Vault then removes duplicate values and exports all applicable E2B codes in ascending numerical order. Including products in evaluations ensures a complete list of follow-up classifications, particularly for cases involving multiple products or combination products.

Key enhancements include:

• Product-Level Evaluation: For each device product exported in a G.k.12.r block, Vault checks the Device Follow-Up Type field on the Case Product and repeats the FDA.G.k.12.r.2.r data element for each applicable E2B code.
• Case-Level Merging & Fallback: Vault then checks the Case-level multi-select Device Follow-Up Type field (device_multi_followup_type__v) and exports the FDA.G.k.12.r.2.r data element for any codes that did not apply at the Case Product level. If the multi-select field is blank, Vault checks the Case-level single-select Device Follow-Up Type field (device_followup_type__v) to export E2B codes based on the Device Follow-Up Type controlled vocabulary, if needed.
• Ascending Code Ordering: All applicable E2B codes resulting from the aggregated product and case evaluations appear in ascending numerical order in E2B(R3) files.

Evaluate One Last Time Reporting from Localized CasesAuto-on26R2.2

To streamline local case processing, when running Re-evaluate Reporting Obligations from a Localized Case, Veeva Safety now automatically executes local One Last Time (OLT) evaluation alongside localized rules. Previously, re-evaluating reporting obligations on a Localized Case processed only local rules, which could cause Vault to misinterpret prior global submission history and incorrectly flag valid submissions as Not Submittable.

Safety Aggregates: Cumulative Start Date FilterAuto-on26R2.2

Preparing regulatory aggregate safety reports sometimes requires control over reporting timeframes to meet global compliance requirements. Previously, cumulative aggregate reports automatically pulled in all historical cases up until the specified Data Period End, preventing organizations from defining a custom start date to align with key milestones such as the International Birth Date (IBD) or country specific registration dates, limiting flexibility when generating cumulative reports for specific health authority guidelines.

With this release, Veeva Safety introduces a new optional Cumulative Start Date filter for Safety Aggregate Reports (DSUR, PBRER and PSUR). Organizations can now filter cumulative cases using key milestones including the International Birth Date (IBD), regional birth dates, or custom dates of interest prior to report generation. This ensures cumulative reports reflect precise regulatory timeframes while eliminating the need for manual data filtering. Optionally, to display the filter higher on aggregate reports, move the field on the Aggregate Report object layout to below Data Period End.

Safety Aggregates: Country FilterConfiguration26R2.2

Meeting specific Health Authority requirements for aggregate safety reporting often requires localized data views. Previously, users could not apply country-level filters to Safety Aggregate Reports (DSUR, PBRER, PSUR). Generating targeted reports to satisfy regional Health Authority requests required manual data filtering post-generation, increasing operational effort, and the risk of error.

With this release, Safety Aggregate Reports (DSUR, PBRER, PSUR) now support flexible country filtering capabilities. Organizations can easily include or exclude case data based on specific country criteria, streamlining the creation of targeted aggregate reports tailored directly to individual Health Authority requirements.

Safety DSUR: Expectedness LogicAuto-on26R2.2

Accurately reporting aggregate safety data in Development Safety Update Reports (DSURs) requires precise handling of adverse event expectedness across complex trials. Previously, when a single DSUR included multiple study products with differing expectedness statuses for the same event, cumulative and interval Serious Adverse Reaction (SAR) tabulations defaulted to displaying the event as Expected if marked Expected for at least one product. This forced safety teams to manually review and adjust tabulations to align with conservative reporting standards.

With this release, Veeva Safety updates the expectedness aggregation logic for multi-product DSURs. Vault now automatically evaluates expectedness across all study products included in the report and applies conservative logic: if an event is Unexpected for any single study product, the aggregate tabulations classify the event as Unexpected overall.

Safety CIOMS II: Complete PDF Export Data VisibilityAuto-on26R2.2

Maintaining complete data visibility for Health Authority (HA) submissions is critical to regulatory compliance. Previously, when large amounts of data were returned for a case, content in single Excel cells could be cut off due to row height limitation. Because PDF exports directly mirror the Excel layout, this truncated content was missing entirely from final PDF submissions, introducing potential compliance risks for organizations.

With this release, Vault introduces updated report formatting to ensure all cell content is fully displayed during PDF export. By restructuring the layout specifically for the CIOMS II, data is now distributed across multiple rows to prevent cell overflow and guarantee that generated PDFs reflect complete case details.

Align MFDS Validation Criteria with Submission LogicAuto-on26R2.2

To ensure pre-submission validation checks accurately reflect actual E2B export behavior, Veeva Safety updates standard MFDS E2B(R3) validation criteria for South Korea ICSR transmissions. Previously, certain out-of-the-box validation rules evaluated global Case fields without accounting for localized data fallback logic, IDMP-MPID configurations, or device constituent product exclusions. This update aligns Validation Criteria expressions directly with Veeva Safety’s MFDS export logic, eliminating false validation failures and ensuring all mandatory data elements are properly populated prior to submission.

Key enhancements include:

• Localized Fallback Logic Alignment: Validation Criteria for Medicinal Product ID (MPID) on Case Products and Past Drug History (MFDS.D.8.r.1.KR.1b and MFDS.G.k.2.1.KR.1b series) now verify the Local MPID on localized records first before checking global Case fields (MPID), matching Vault’s domestic E2B export hierarchy.
• Device Constituent Exclusion: Case Product validation rules now exclude Device object types, preventing false validation failures on Combination Product cases where device components do not carry drug MPID codes.
• IDMP-MPID & Foreign Case Refinements: Validation Criteria for Medicinal Product Version and Substance ID Version (the MFDS.G.k.2.1.KR.1a and MFDS.G.k.2.3.r.1.KR.1a series respectively) incorporate IDMP-MPID lookup logic and restrict foreign-specific WHODrug version checks exclusively to foreign Case submissions.

Safety Workbench

MedDRA Browser Filter for Reports & DashboardsAuto-on26R2.2

Veeva Safety Workbench now allows users to filter Workbench Reports and Workbench Dashboards using an interactive MedDRA browser, enabling precise term selection across all hierarchy levels (SOC, HLGT, HLT, PT, and LLT). This feature eliminates manual coding, reduces selection errors, and accelerates analysis workflows for safety teams.

Large Custom MedDRA Query Filter SupportAuto-on26R2.2

Veeva Safety Workbench now supports filtering by MedDRA Queries that include all lower level terms (LLTs) in the MedDRA library. Previously, users could filter by custom MedDRA Queries (CMQs) with less than 20,000 LLTs only. This feature improves analysis accuracy for complex CMQ configurations.

Maximize Dashboard Component DisplayAuto-on26R2.2

This feature simplifies the analysis of large datasets by expanding data visibility beyond standard dashboard sizes. Veeva Safety Workbench users can now maximize individual dashboard components into a full-screen mode. This provides more space for data visualization while preserving active filters, sorting, and scroll positions.

Launch Dashboard from Case Series & Saved FiltersConfiguration26R2.2

Users can now navigate to a Workbench Dashboard directly from a Workbench Case Series or saved Workbench Dashboard Filter. This feature eliminates manual filter setup and facilitates initiating data analysis straight from object records, significantly streamlining the review process.

Case Series Import by Related FieldsConfiguration26R2.2

This feature simplifies ad-hoc reporting by enabling users to create custom Workbench Case Series using external identifiers. Veeva Safety Workbench now supports importing CSV files with alternative matching criteria, such as External System IDs or specific Case versions. This automated matching eliminates manual data transformation when analyzing large case lists.

PMDA J-DSUR Aggregate ReportsConfiguration26R2.2

Veeva Safety Workbench provides PMDA regulatory compliance for Japanese Development Safety Update Reports (J-DSUR). This feature introduces the ability to generate the following tabulations:

• J-DSUR Annex Form 2: Clinical Trials
• J-DSUR Annex Form 2: Post-Marketing Clinical Trials

Admins can configure these reports to run individually or together within their existing DSUR Report Set.

Safety Signal

Include Additional FAERS & VAERS DataConfiguration26R2.2

This feature enhances signal detection precision by introducing additional FDA AEMS (Adverse Event Monitoring System, formerly known as FAERS) and Vaccine Adverse Event Reporting System (VAERS) data fields into Veeva Safety. Users can leverage critical information, such as patient weight, directly within Workbench Dashboards and safety views. This feature empowers teams to create specific subgroupings for Signal Calculations and access richer case data.

Statistical Data Direct Links to DashboardAuto-on26R2.2

This feature accelerates Signal Case Series review by seamlessly connecting statistical results to underlying case data. Veeva Safety Signal now presents Statistical Data field values as clickable hyperlinks that open a default Signal Case Series dashboard. This feature enables users to instantly analyze the exact Signal Case Series behind case counts without requiring additional user clicks. 

SafetyDocs

PSMF Binder Periodic Review GroupingConfiguration26R2.2

Managing Pharmacovigilance System Master File (PSMF) periodic reviews across multiple binders often requires operational flexibility to align with organizational oversight models. Previously, SafetyDocs automatically consolidated all documents scheduled for review that month into a single PSMF Periodic Review record, limiting Admins from isolating review tasks by binder when different teams or specialized workflows were required.

With this release, Veeva SafetyDocs introduces a new setting for configurable grouping and generation of PSMF Periodic Reviews, allowing Admins to determine whether periodic review tasks are consolidated into a single record or partitioned into unique records based on the binder. This provides granular control over review management, allowing organizations to streamline oversight without altering established review assignments. Regardless of the selected configuration, Vault supports assigning multiple reviewers to PSMF Document Reviews across both single and binder-partitioned review records.

Display Document Title in PSMF LogbookConfiguration26R2.2

With this release, Veeva SafetyDocs extends the PSMF: Display Document Title in PDF Table of Contents feature to ensure documents represented in both the PSMF Table of Contents and the PSMF Logbook within the generated PSMF PDF are displayed using the same document field (Title or Name). Admins can configure their Vault to display either document titles or names in the table of contents and logbook of the generated PSMF PDF, enabling organizations to leverage more descriptive or formal titles.

PVA Email CommunicationsConfiguration26R2.2

Managing Pharmacovigilance Agreement (PVA) obligations often requires tracking distribution activities that do not involve an actual document. Previously, distribution events within SafetyDocs, including both individual PVA Activities and PVA Multi-Agreement Activities, strictly required a related document to be attached. This created administrative friction for routine activities not requiring a document such as audit or inspection scheduling, often forcing teams to rely on placeholder files.

With this release, Veeva SafetyDocs removes the mandatory document requirement for partner distribution events. Organizations can now manage PVA-related communication distribution activities without attaching a file, streamlining workflows while maintaining clear compliance tracking for all partner obligations.

Earliest Due Date Calculation for Multi-Agreement ActivitiesAuto-on26R2.2

Managing timelines and regulatory commitments requires automated and reliable due date calculation across safety activities. With this release, Veeva SafetyDocs extends the Earliest Due Date calculation logic directly into the Generate Related Activities action, allowing Vault to populate the Earliest Due Date on the PVA Multi-Agreement Activity during activity generation. This ensures PV Operations teams can take timely action when PVA Obligation timelines vary by PV Agreement.

Simplified RMP Local Record AutomationConfiguration26R2.2

Managing local risk management plans and local implementation strategies in Vault often required extensive setup, including maintaining full product libraries and global product registrations. For organizations that do not track global product registrations within Vault, this created unnecessary administrative overhead and forced complex configuration workarounds.

With this release, Veeva SafetyDocs streamlines the creation of Local RMPs and Local Implementation Strategies by removing global registration dependencies. By updating the data model on both the Core RMP and Core Implementation Strategy objects, Vault now enables organizations to define covered countries directly on these records, providing greater operational flexibility and simplifying local risk management without requiring a full Product Registration library.

QualityOne

QualityOne QMS

Exclude Inactive Requirements from Inspection ActionsAuto-on26R2.2

The following Inspection actions now complete successfully if the associated Inspection Plan contains inactive Inspection Plan Requirements:

• Analyze COA
• Analyze Inspection
• Generate Samples

This update allows users to complete inspection analysis processes which previously failed due to inactive Inspection Plan Requirement records.

RegulatoryOne

Compliance Management

Formulation Questionnaires: Delete Attachments Upon Checklist DeletionAuto-on26R2.2

This feature ensures when deleting a Formulation Questionnaire type of Checklist, Vault also deletes its attachments.

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.