New in 26R2 Limited Release

Limited Release Dates: May 1, 2026 (26R1.2); June 12, 2026 (26R1.3); June 26, 2026 (26R1.4) | General Release Date: August 7, 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

Responsive UIAuto-on26R1.2

The Vault user interface now automatically scales to a user’s browser width, collapsing sidebars to maximize space and adjusting field layouts to reduce horizontal scrolling.

Even without adjusting browser width, users can manually collapse and expand sidebars, allowing them to focus on content over navigation, if desired.

If a sidebar is manually collapsed, Vault remembers that as a user preference across tabs.

Also, Vault now respects font size changes made within a user’s browser preferences, ensuring a consistent experience across different sites and web applications users may leverage.

Copy Link for RecordsAuto-on26R1.2

Vault supports a new Copy Link action for object records, allowing users to copy a clean and shortened URL to share with others. The copied link automatically redirects users to the record detail page when pasted into a browser web address bar. This new action supports new shortcut keys.

Managing Documents

Launch Collaborative Authoring from LinkConfiguration26R1.2

For Document Notification Templates for single document workflows, Admins can now configure templates to include links to join collaborative authoring sessions directly from email notifications. This enhancement can streamline the user experience by allowing authors to more quickly work on documents that they need to author.

To enable this feature, Admins can use a new token, ${docCollaborativeAuthoringSessionLink}, in HTML link syntax.

For instance, the following notification would show the Document Name as a hyperlink that launches collaborative authoring:

<a href="${docCollaborativeAuthoringSessionLink}">${docNameNoLink}</a>

When recipients click one of these links from an email, they are required to authenticate (unless they are already authenticated in that Vault), and are then routed to a new landing page that automatically opens the document in collaborative authoring.

This enhancement applies to workflows run on single documents only (where Use workflow for single document is enabled) that are configured to use Document Notification Templates. With the HTML syntax, if including a different token to display as the link (such as ${docNameNoLink} above), the token must not resolve to its own hyperlink.

Learn more about Email & Messages Administration and Collaborative Authoring.

Dynamic Styling for Claim-Based Link AnnotationsAuto-on26R1.2

Reviewers can now quickly gauge how a Claim-based link annotation was created, as well as the current lifecycle state of the associated Claim record.

Vault now displays distinct annotation banner colors based on the method of creation. In addition, for Auto Link annotations only, when the related Claim is withdrawn, the annotation banner color changes to silver.

Vault also now displays a colored circle indicator to better highlight the related Claim’s lifecycle state.

Banner colors:

• Dark blue for Claim Link, Approved Link, Document Link, and Permalink Link
• Blue for Auto Link
• Light blue for pending Suggested Link
• Silver for Auto Link when the Claim record is withdrawn

Circle indicator colors:

• Green for Approved
• Red for Withdrawn
• Orange for all other states

Learn more about Claim Link Annotations.

Managing Data

Document Fields in Object Formula FieldsConfiguration26R1.2

Admins can configure formula fields on objects to use document fields if the object references one or more documents. This feature allows Admins to use or display data from a document selected in a document reference field, such as Major Version, Minor Version, Document Number, and other supported document field types.

Control Binding for Object FieldsAuto-on26R1.2

This feature allows Admins to bind object fields to a control. In the past, Admins could only configure controls on a layout. An object field with control binding is always displayed using that control in record detail views, list views, and related object sections.

Word Formatted Output: Support for GetRelatedRecords FormulaConfiguration26R1.2

When configuring Word Formatted Output templates, Admins can now leverage the GetRelatedRecords() formula in HideRowIf() and HideTableIf() syntax.

This feature allows scenarios where an Admin may need to hide a row or table based on whether or not a particular related record exists. For example, the following formula hides the Impact Assessment Summary row if no Impact Assessment records are associated to the Change Control object by combining CountA() and GetRelatedRecords():

${HideRowIf(CountA(GetRelatedRecords($impact_assessments__vr))=0)}

Learn more about Managing Word Formatted Output Templates.

Process Optimization

Layout Profiles Supported in Action TriggersConfiguration26R1.2

Admins can evaluate Layout Profiles in a condition and use Update Records and Update Current Record Action Triggers to set a Layout Profile.

Relative Date Filters in JobsAuto-on26R1.2

Admins can now configure job definitions with dynamic date-based expressions in datetime fields, enabling automated execution based on relative date filters rather than manual, fixed-date updates.

Analytics

Exclude Inactive Users in Report FiltersConfiguration26R1.2

Reports can now exclude inactive users from being available in report filters and prompt dropdowns. This can be controlled for all reports with the Allow inactive users to be used in reports Admin checkbox in Admin > Settings > General Settings:

If enabled at the Vault level, users can still choose to exclude inactive users on a case-by-case basis using a new Show inactive users checkbox in Advanced Options when creating and editing reports:

Both checkboxes are selected by default to maintain current behavior.

Learn more about Creating Reports.

Permissions & Access

Enforce Atomic Security in Audit LogsAuto-on26R1.2

When a user is restricted from seeing certain fields via Atomic Security, any updates to these fields are hidden when the user views an individual object record audit trail. Prior to 26R2, users could still see information through the audit trail about fields that were restricted elsewhere via Atomic Security, which often meant that Admins would need to remove permissions to the audit trail altogether for these users.

This enhancement ensures users can have the ability to see record audit trails while respecting any applicable field-level Atomic Security. This enhancement does not apply to the Object Record Audit History in Admin > Logs, and applies specifically to object records (as field-level Atomic Security is not available for documents).

Learn more about Configuring Atomic Security on Fields and Viewing Audit Trails.

Admin Experience

Layout Profile: Summary Dialog for Adding & Removing UsersAuto-on26R1.2

When adding or removing users from a Layout Profile, Vault now displays a summary dialog if any users were skipped due to an error. If all users were successfully added or removed, Vault continues to display a success banner instead.

Query ProfilerAuto-on26R1.2

This feature allows Admins and Developers to monitor VQL query performance with the new query profiling tool. Analysing the profile of queries is a key part in monitoring their performance and overall health, but this process has been challenging in the past.

With Query Profiler, the results make it easy to analyze the queries running in Vault by looking at the data obtained during a profiling session. Users must start a profiling session where they are also able to set filters on what kind of VQL queries should be included in the results. These filters include:

• Origin: Filters where the VQL query originated from (API, SDK, or ALL).
• Targets: Filters the specific Query Targets of the VQL query (for example, restricting to queries on user__sys).
• Result Count: Filters queries to only be included if their result count is in a minimum or maximum range.
• Query Time: Filters queries to only be included if their execution time is in a minimum or maximum range.
• Response Status: Filters whether the query was a SUCCESS, FAILURE or if it received a WARNING.

Direct Data API: Additional Document Metadata in Workflow ExtractsAuto-on26R1.2

Workflow Item and Workflow Task Item extracts will include additional document metadata information. The field additions will be captured in the incremental metadata.csv (and correspondingly in the metadata_full.csv).

Workflow Item extract includes additional document fields to maintain the stamped document metadata for expired workflows:

• document__sys
• document_version__sys

Workflow Task Item extract will include additional document fields to maintain the stamped document metadata for expired workflows:

• document_id__sys
• verdict_document_major_version_number__sys
• verdict_document_minor_version_number__sys
• verdict_document_version_id__sys

Minor Enhancements

Add API Name to Document Type Details ObjectAuto-on26R1.2

A new Document Type Name (document_type_name__v) field is added to the Document Type Details (doc_type_detail__v) object. This provides the public API name of the mapped document type, whereas previously only the document type’s label was available in the object record.

Download as PDF: Deduplicated Records in Related Join Object SectionsAuto-on26R1.2

When using the object record Download as PDF functionality, the generated PDF now consolidates duplicate records in the same manner as the Vault user interface.

This functionality applies when duplicate records are associated via simple join relationships or complex join relationships configured to display as simple.

Learn more about Download as PDF and About Object Relationships.

File Count Validation for Record AttachmentsAuto-on26R1.2

Vault now informs users that they cannot drag and drop more than 100 files in a record detail page. Attempts to do so triggers an error and cancels upload for all files.

Veeva Connections

Clinical Operations-EDC

Clinical Operations-EDC Connection: Improved Error Handling for Protocol Deviations 26R1.2

The Clinical Operations-EDC Connection now introduces granular error isolation for Protocol Deviations. Previously, a single Protocol Deviation containing an unmapped value could generate a Message Processing Error (MPE), causing the entire batch to fail across studies. Now, If an EDC Protocol Deviation contains a Category or Subcategory value that is not mapped in CTMS, Vault processes all other valid records in the batch successfully. Vault also generates a detailed User Exception Item (UEI) specifically for the affected record, allowing you to quickly identify and resolve mapping gaps.

Learn more about other new Clinical Operations features below.

Clinical Operations-EDC Connection: Restricted Subject Visit CreationAuto-on26R1.2

Previously, Clinical Operations users faced data gaps because Unblinded Subject Visit records in Clinical Operations Vailts were only created in case of discrepancies between the Restricted and the Unrestricted details of the Event in EDC (such as status, SDV, etc.), potentially missing key restricted events.

To resolve this, Vault now automatically creates Unblinded Subject Visit data every time a restricted event occurs in EDC, regardless of data differences.

By simplifying the logic, this feature improves data completeness and increases efficiency reducing the need for manual verification.

Learn more about other new Clinical Operations features below.

Safety-EDC

Safety-EDC Connection: Retain Primary Designation for Multi-Event CasesAuto-on26R1.2

Within the Safety-EDC Connection, the Safety Case Follow-Ups Honor Safety Decision feature is critical for reducing noise and sharing and tracking Safety decisions. However, Veeva EDC relies on a primary event to define its top-level structure, while Safety maintains a case-centric view. Previously, adding a new Adverse Event (AE) during a merge or follow-up triggered a change to the primary event. This automation often overrode the deliberate decisions of medical reviewers and caused EDC to inadvertently drop events in follow-up transmissions.

With this release, the Safety-EDC Connection introduces more stable logic for EDC-sourced Cases to ensure that primary event designations remain unchanged unless manually adjusted. By preventing automatic primary event updates, the connection maintains higher data integrity and respects the decisions of case processors.

Key updates include:

• Stable Merges: When merging an Inbox Item containing a new AE into an existing Case using the Merge to Current action, the new AE is no longer automatically set to primary. Instead, the Rank value is left blank.
• Consistent Follow-ups: When creating a new Case version using the Create Follow-up action, net-new AEs default to a non-primary status. This ensures the preservation of the existing case structure across versions.
• Explicit Safety Decisions: For both merge and follow-up actions, the resulting Safety decisions explicitly include an “add” decision for the new event to inform EDC of the update without disrupting the primary event hierarchy.
• Rank Requirement Cleanup: To eliminate data assumptions, any time an AE is received and not designated as primary (Rank value of 1), the Rank field remains blank.

Learn more about other new Safety features below.

Quality-RIM

Quality-RIM Connection: Enhanced Change Control for MaterialsConfiguration26R1.2

This feature enhances the existing Quality-RIM Connection by enabling users to apply change controls against Material records in addition to Products. Materials include packaging, active substances, and inactive ingredients. This level of detail facilitates Batch Release by supporting changes at the granular Material level where Quality Materials relate to RIM Packaging, Container, Active Substance, or Inactive Ingredient records. Tracking changes at the material level helps organizations make informed decisions about releasing batches.

What’s New?

The Enhanced Change Control (ECC) integration now supports defining changes at the Material level. Vault includes the following updates to the RIM and QMS data models and connection data flows.

Data Model Changes

• RIM: Vault now includes four new object types for the Change Item and Activity Change Item objects: Packaging Change, Container Change, Active Substance Change, and Inactive Ingredient Change. Each type includes a new ID field that references the related record, such as the packaging__v field on the Packaging Change object.
• QMS: The Regulatory Change Item and Regulatory Activity Item objects now include the Material object type (introduced in 26R1).

Connection Data Flows

Vault syncs the following items from QMS to RIM:

• Packaging Change Items: When you create Regulatory Change Item records in QMS where the type is Material and the related material is a “Finished Material” (with the RIM Source Object of “Packaging” subtype), Vault syncs the record to RIM as a Change Item of the Packaging Change type.
• Active Substance Change Items: Regulatory Change Item records created in QMS where the type is Material and the related materials are “Raw Materials” (with the RIM Source Object of “Active Substance”) sync to RIM as an Active Substance Change.
• Inactive Ingredient Change Items: Regulatory Change Item records created in QMS where the type is Material and the related materials are “Raw Materials” (with the RIM Source Object of “Inactive Ingredient”) sync to RIM as an Inactive Ingredient Change.
• Container Change Items: Regulatory Change Item records created in QMS where the type is Material and the related materials are “Raw Materials” (with the RIM Source Object of “Container”) sync to RIM as a Container Change.

Key Benefits

• Granular Control: Quality users can create change controls against detailed material-level data from RIM.
• Streamlined Impact Assessment: RIM users can assess the regulatory impact of material changes and feed those results back to Quality automatically.
• Improved Batch Release: Facilitates a more detailed Batch Release process by ensuring all material-level changes are tracked across both Vaults.

Additional Considerations

• Material Alignment: Material records must be aligned between RIM and Quality through the Quality-RIM Connection’s Product Data integration.
• Material Selection: Any Materials that weren’t sourced from RIM (where the Link field is not populated), will not be synced to RIM as a Regulatory Change Item. Likewise, any Materials sourced from RIM with the RIM Source Object of either “Active Substance Alias” or “Inactive Ingredient Alias”, will not be synced to RIM as a Regulatory Change Item either, as these are purely used to search for the related Active Substance or Inactive Ingredient records.
• Existing Integration: The existing integration point for Activity Change Items (RIM) and Regulatory Activity Items (QMS) is reused, as the type is associated with the related item.

Learn more about other new Quality and Regulatory features below.

Quality-RIM Connection: Document Creation Triggers Outbound JobAuto-on26R1.2

The Quality-RIM Document Exchange integration has been enhanced to ensure that Vault will trigger the integration if documents or document versions are created directly in their Steady state, automatically creating the CrossLink in the target Vault.

Learn more about other new Quality and Regulatory features below.

RIM-Clinical Operations

RIM-Clinical Operations Connection: Submission Tracking EnhancementsConfiguration26R1.2

What’s New?

This release expands the Submission Tracking Integration (released in 25R2) to track additional clinical trial application outcomes, specifically Withdrawn and Study May Proceed. When a Regulatory Objective related to a clinical trial application enters one of these new state types, the RIM-Clinical Operations Connection transfers the data from RIM to Clinical.

Key updates include:

• New State Types: New Withdrawn and Implicitly Approved state types and Submission Verdicts are provisioned in RIM to support the connection.
• Mapping Logic
  • To ensure cross-system alignment, the connection translates RIM verdicts into specific fields on Clinical Milestones, where the RIM Withdrawn verdict maps to the Clinical Withdrawn submission decision value.
  • RIM’s Study May Proceed verdict maps to the Clinical Approved submission decision value.
• Automated Verdicts
  • Non-EU procedures: The Regulatory Objective lifecycle entry action on the Withdrawn and Implicitly Approved states updates the related CDDs’ lifecycle states in RIM to Withdrawn/Study May Proceed, which then automatically populates the HA Application and HA Approval milestones in Clinical.
  • EU CTR procedures: Users can manually set a verdict (for example, “Withdrawn” or “Study May Proceed”) on a specific Country Decision Detail (CDD) record whenever that specific country provides a decision. Every time a verdict field is updated on a CDD, the connection immediately transfers that data to the specific Clinical Milestone for that country. Once the overall regulatory process is complete or a global decision is made (like withdrawing the whole application), the user moves the Regulatory Objective (RO) to a final state (for example, “Withdrawn” or “Implicit Approval”). This RO state change triggers an automated cascade (via entry action) that updates all remaining related CDDs to that same state or verdict. These cascaded updates trigger the connection to push the final status to all relevant Clinical Milestones across all countries involved in the procedure.
• Date Field Handling
• Withdrawn Applications: When a verdict is set to Withdrawn, the actual_finish_date__v is cleared (made empty) for EU CTR Part I/II, EC IRB Approval, and HA Application/Approval milestones.
• Implicit Approvals: When set to Study May Proceed, the actual_finish_date__v on Clinical milestones is automatically populated based on the submission_decision_date__v from RIM.
• Milestone Re-use: When a resubmission is required and a new Regulatory Objective is created for an Initial Application, the connection automatically populates relevant Study and Country Milestones in Clinical. Vault ignores whether the link__sys field is already populated, eliminating previous User Exception Messages.
• Updated Unlinking Behavior: When a CDD record is made inactive in RIM, the connection now triggers an automated unlinking process for corresponding milestones:
• Unlink & Retain Data: For Archived studies or Completed/Inactive milestones, the link__sys is cleared but existing field data remains.
• Unlink & Clear Data: For Active studies where the milestone is not Completed or Inactive, both the link__sys and all mapped fields are cleared.

Key Benefits

• Improved Tracking Accuracy: Provides a more comprehensive view of clinical trial application statuses by including “Withdrawn” and “Study May Proceed”.
• Increased Automation: Reduces manual data entry by automatically triggering field updates and data transfers across the connection based on lifecycle state changes.
• Streamlined Resubmissions: Simplifies the resubmission process by allowing the automatic re-use of existing Clinical milestones for new regulatory objectives.

Additional Considerations

• Milestones in the Complete lifecycle state are still ignored and will not have their link__sys populated.

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

Clinical Operations

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

CTMS

Remove Reliance on Risk Library for Study Specific Risk AssessmentsConfiguration26R1.2

During Risk-Based Quality Management (RBQM) in clinical trials, study teams often identify risks, critical processes, or mitigations that are unique to a specific protocol. Prior to this feature, Veeva CTMS required these specific elements to exist in a Global Risk Library before they could be utilized in a Study Risk Assessment. This dependency created inefficiencies for customers who were forced to navigate the administrative process of updating a global library, which delayed the finalization of risk assessments.

This release introduces an expansion of RBQM capabilities, formerly named Risk-Based Study Management (RBSM), that removes the strict reliance on Risk, Risk Mitigation, and Critical Process library records. Users now have the flexibility to:

• Create Study-Specific Risks: Manually enter unique Short Description for risks, mitigations, and critical processes directly on the record without a library reference.
• Copy from Another Study: Use the enhanced Generate Risk Assessment action to pull study-specific risks, critical processes, and critical data directly from an existing Study into a new one.
• Reference the Risk Library: Continue to link to Global Library records when standardization across studies is preferred.

This update empowers Sponsors and CROs to move beyond the constraints of one-size-fits-all libraries, enabling a truly agile risk management approach that significantly accelerates the overall risk assessment process.

Critical to Quality (CtQ) Factors Supported for RBQMConfiguration26R1.2

Critical to Quality (CtQ) factors are fundamental parameters of a clinical trial guaranteeing subject safety and the reliability of study results (such as primary endpoints, recruitment targets, or eligibility criteria). In Risk-Based Quality Management (RBQM), these factors serve as the foundation for identifying which risks truly matter to the success of a study. Prior to this feature, Veeva CTMS did not have a dedicated structure to track these CtQ factors This often forced study teams to manage the CtQ factors outside the system, often in spreadsheets, which led to a disconnected risk assessment process.

This release includes data model enhancements to integrate CtQ factors into the RBQM workflow. Users can now:

• Track & manage CtQ factors in Study Risk Assessments.
• Link CtQ to Critical Processes and Data for full traceability.
• Automate setup via the updated Generate Risk Assessment action, which pulls CtQ factors from Risk Templates or existing Study Risk Assessments.

This enhancement directly promotes compliance with Quality by Design principles by anchoring CtQ factors within the entire Study Risk Assessment process. By centralizing this strategy within Vault, Sponsors and CROs can significantly improve the documentation of their study strategy, providing a transparent, audit-ready record of how strategic quality factors drive operational oversight and patient safety.

Monitoring Event Follow Up Item Seeding Logic UpdatesAuto-on26R1.2

This feature updates the logic for the Seed Monitoring Follow-Up Items action on Monitoring Events. The system now considers the Follow Up Item’s Opened Date when seeding Closed Follow Up Items into Monitoring Events.

If a Follow Up Item’s Opened Date is before the current Monitoring Event’s Actual Visit Start Date and the Follow Up Item is resolved, Vault seeds the Follow Up Item as a Closed Follow Up Item considering Completion Date values up to today’s date.

If a Follow Up Item’s Opened Date is after the current Monitoring Event’s Actual Visit Start Date and the Follow Up Item is resolved, Vault seeds the Follow Up Item as a Closed Follow Up Item considering Completion Date values up to the current Monitoring Event’s Actual Visit End Date.

CTMS, Disclosures

Move CTN Setting back to CTMS SettingsAuto-on26R1.2

Admins can now enable the CTN Setting in the CTMS section of the Admin Settings page.

eTMF

TMF Quality ReviewConfiguration26R1.2

Maintaining a healthy Trial Master File (TMF) requires more than just verifying individual document integrity at the point of submission. While tactical document quality checks are essential for ensuring correct metadata, formatting, and signatures on an isolated basis, they often fail to capture the “relational” health of the TMF, specifically whether the collective body of documents provides a coherent and complete narrative of the trial expected per Good Clinical Practice (GCP) and global regulatory requirements. Historically, most organizations performed these quality reviews manually using external spreadsheets or reports. However, this disconnected approach makes it difficult to track review progress, manage sampling consistently, and provide a clear audit trail of sponsor oversight, ultimately increasing the risk of inspection findings or late-identified documentation gaps.

The new TMF Quality Review feature introduces a centralized framework to manage these periodic and strategic TMF reviews directly within Veeva eTMF. This solution streamlines the process through five key pillars:

• Standardized Strategy: TMF Admins define Quality Review Templates to standardize which document types require review, the specific guidance reviewers should follow, and the periodic frequency of these checks. Study Managers can then leverage these templates when creating Quality Reviews for specific Studies.

• Coordinated Execution: Once the Quality Review owner is identified and the review schedule is confirmed, Quality Review Cycles can be triggered automatically by Study milestones or initiated manually. Quality Review Owners can then precisely define the scope of the review by selecting specific Review Cycle Items, which can represent the Study Level, specific Study Countries, or individual Study Sites. Specific reviewers are assigned to each selected country or site to ensure comprehensive trial coverage.

• Intelligent Sampling: Instead of manual selection, the system identifies the review scope using Fixed Sampling Percentage or Risk-Based logic based on Document Types and Subartifacts. This provides teams the flexibility to tailor their sampling strategy based on various factors.

• Guided Review Interface: Reviewers are guided through their assigned scope starting from the Review Cycle Item, which displays the full list of documents sampled for their specific area. A dedicated Quality Review panel on each document provides specific Review Guidance to ensure every team member evaluates coherence and completeness against the same objective standard.

• Integrated Remediation: When a gap in the trial narrative is found, reviewers raise Quality Issues or Clinical User Tasks directly from the document. These findings are automatically linked to the review cycle, providing a transparent record of identification and resolution

This enhancement transforms TMF quality management into a proactive, system-driven strategy. It helps organizations ensure strict adherence to their internal TMF Review Plans and facilitate the early identification of deficiencies such as gaps, errors, or late filings. Ultimately, this framework maintains the coherent narrative regulators expect, keeping the trial ready for inspection at any time to maximize inspection success.

OpenData Clinical

Display Preferred Affiliation in OpenData Clinical DetailsAuto-on26R1.2

This release provides increased Investigator affiliation flexibility by allowing users to designate a primary or preferred Contact Information record within a Vault. To ensure data integrity, Vault enforces a primary constraint for contact records. The OpenData Clinical Details section dynamically displays the address and contact details of the chosen primary affiliation. This enhancement deprecates the manual Change Primary Affiliation action in favor of a standard Is Primary field on Contact Information records, making it easier for users to manage preferred affiliations.

Primary Country for OpenData Clinical InvestigatorsAuto-on26R1.2

Primary Country is now automatically populated for OpenData Clinical Investigators. Vault leverages curated global directory data to set the value based on the Investigator’s primary site affiliation. This enhancement supports usage of the Clinical Operations-Vault CRM Connection when OpenData Clinical is enabled. OpenData Clinical provides the primary country for Investigators, which Vault needs to route activities to regional CRM instances.

Support for Investigators without Site AffiliationsAuto-on26R1.2

This feature enables OpenData Clinical to deliver records for Investigators found in clinical trial registries, even when a specific affiliation to an OpenData Clinical Site cannot be confirmed. Previously, Vault only delivered Investigators with at least one confirmed site affiliation.

Payments

Fee Schedule Template BuilderConfiguration26R1.2

The Fee Schedule Template Builder is a powerful new workspace designed to simplify the planning, calculating, and managing of study costs. This feature provides a dedicated app layout for building Fee Schedule Templates that display information in a dynamic and intuitive grid layout.

The Fee Schedule Template Builder includes:

• Interactive Fee Management Grid: A spreadsheet-like interface that allows you to manage procedures, visits, and costs in a single view. You can quickly toggle between different views for Procedures, additional Subject Costs, and Site Fees.
• Flexible Reimbursement Categories: You can designate Procedures as:
  • Included: The amount is added to the total visit cost.
  • Invoiced/Contingent: Items not included in the Visit Costs but included as separate paid items when applicable. These costs are included in maximum cost calculations.
  • Standard of Care: Procedures performed as standard medical practice. Not included in Visit Cost or Maximum Cost Calculations.
• Comprehensive Budget Overviews: Calculated visit costs, broken down to visualize overhead, tax, and total overall costs. Additional calculations for total costs per subject and maximum site costs based on planned enrollment help visualize total financial commitments.
• Real-Time Cost Summaries: As you enter amounts, total and maximum projected costs are automatically calculated, giving you visibility into how individual line-item changes impact the overall budget.
• Improved Navigation: The grid supports keyboard navigation, allowing you to move through cells and update costs without relying on your mouse.

This feature transforms a complex, manual process into a live, integrated workspace, reducing the risk of errors, streamlining processes, and providing improved visibility into overall study costs.

Payments: Currency RoundingAuto-on26R1.2

Veeva updated how Vault handles currency rounding to better support global clinical trials. Previously, when rounding for some currencies using different formats than two decimal places, the system would not round the corresponding Amount value based on the currency. Now, Payments functionality handles the local currency for any Vault currency, such as zero-decimal currencies as well as those requiring three decimal places, saving the value with the same minor units as the currency selected.

Tax Rates: Track Total PercentageAuto-on26R1.2

The system now automatically calculates and validates the Tax Rate (Total) on Tax Rate records based on the values entered for Country, Secondary, and Tertiary Tax Rates. This ensures data integrity and prevents Tax Rate miscalculations.

When creating or updating Tax Rate records that are not in use, the Tax Rate (Total) is automatically calculated as the sum of the three individual rates. If a specific rate is left blank, the system treats it as zero for the total calculation. For Tax Rates that are in use, to prevent unintended data changes, users can only update individual tax rates if the new sum matches the existing Tax Rate (Total). If there is a mismatch, the system displays an error message.

Site Connect

Document Action FilteringConfiguration26R1.2

Administrators can now control the distribution actions available to users by specifying either Revise & Return or None in the new Available Actions field when configuring the Send Document to SiteVault action on document lifecycle states.

By selecting a specific action—or allowing both—organizations can ensure that users only select the distribution action that aligns with the intended business process for documents in that state.

Study Training

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

• No Due Date Matrix Training

My Study Team: Enable Individual Learner Page ViewAuto-on26R1.2

Clinical Research Associates and Principal Investigators require a direct way to view detailed training history for their study staff without relying on reports, which PIs cannot access. Vault now provides a dedicated Individual Learner Page, accessible by clicking a Learner’s card on the My Study Team page, that displays comprehensive views of the Learner’s open, completed, and all Training Assignments.

By accessing this information at the point of need, training managers can now quickly determine whether a Learner is qualified to perform specific tasks or if they require a “nudge” to complete outstanding requirements so that they can ensure study compliance and verify that staff are qualified for specific tasks without waiting for manual reports.

Update Training Assignments Job Performance ImprovementsAuto-on26R1.2

Occasional large-scale events such as migrations can lead to slow background processing and system timeouts due to the massive volume of configuration permutations and logging overhead triggered during deployments.

Vault now introduces infrastructure optimizations for the Update Training Assignments job in Study Training. By focusing on relevant matching paths and utilizing bulk memory filtering for data fetching for assignments, these updates reduce job runtimes by up to 40% and significantly decrease log file sizes.

These enhancements ensure a more stable, scalable environment with faster status updates, even as your study data grows.

CTMS, Study Startup, eTMF

Early-Finish OffsetsAuto-on26R1.2

Vault now automatically pulls in downstream Milestone dates when an upstream Milestone is Completed or Planned earlier than originally expected. Previously, dependencies only pushed dates further out. Now, the system applies the defined Date Offset to ensure timelines stay accurate in both directions. This enhancement works in tandem with other dependency features including Weekday Adjusted Offsets, 26R1 Milestone Dependency Enhancements, and Actual Date Offsets.

New Standard Milestone Types: First IP Received, Operational Closeouts, & Sample TestingConfiguration26R1.2

This feature introduces three new standard values to the Milestone Type picklist to enable more granular tracking of Site Startup and Study Closeout, allowing for a clear distinction between operational activities and system-level state changes.

• First IP Received at Site (first_ip_received_at_site__v): Tracks the initial Investigational Product delivery at the site level, separate from the Site Activated milestone.
• Country Operational Closeout (country_operational_closeout__v)`: Tracks the completion of operational activities at the country level while keeping the country open for final submission processing.
• Study Operational Closeout (study_operational_closeout__v): Tracks the completion of operational activities at the study level (e.g., staff roll-off) prior to the formal system close out and archival.

Milestone Document HardeningAuto-on26R1.2

This feature optimizes Milestone Document creation by reducing the previous five-minute delay, ensuring records are generated in near real-time. This enhancement provides more accurate data for dependent features like the Milestone Workspace, Milestone Document Panel, and Seed Package Documents action. Additionally, when clicking the Unapproved Documents widget on the TMF Homepage, the view has been updated with a new custom Documents page for unapproved items, further removing the system’s reliance on the Milestone Document field.

eCOA

Studio

Rule Instance Ranges and Custom Functions Auto-On26R1.2

Study Builders can reference a range or list of survey instances in rule expressions. The expression engine now includes four new custom functions to complete the following tasks:

• Get all matches
• Check all match
• Check any match
• Determine whether a date or time occurs in a defined time window

This reduces complex syntax, allowing users to build rules faster and more accurately.

Visual Analog Scale (VAS) Enhancements Auto-On26R1.2

Study Builders can configure Visual Analog Scales to include negative numbers, custom labels, answer images, percentages, and custom increments. This flexibility helps surveys meet specific survey design goals and supports more complex configurations.

Library Manager

Linked Reference Materials to Survey Versions Auto-On26R1.2

Veeva Library Managers can link source documents, such as approved copyright surveys and certificates of translation, to specific Veeva Library survey versions. This helps users easily compare licensed versions and complete study setup more efficiently.

Study Home

Clearer Reporting Outage InformationAuto-On26R1.2

During system outages, the reporting section in Study Home displays a specific unavailable message. Sponsor/CRO Staff can refresh the connection without disrupting their access to other tasks in Study Home.

eCOA (Sites)

Clearer Reporting Outage InformationAuto-On26R1.2

During system outages, the reporting section in the Study Details tab displays a specific unavailable message. Site Staff can refresh the connection without disrupting their access to other tasks on the page as well as continue to complete other tasks in the site experience.

MyVeeva for Patients

MyVeeva for Patients

Claiming Unlinked AccountsAuto-On26R1.2

MyVeeva users who have an account created during an in-person workflow will automatically have the system link the new study to their existing MyVeeva account. This provides users with a single account experience and removes the need to manage multiple logins when joining new studies.

Improved MyVeeva Access During Regional OutagesAuto-On26R1.2

MyVeeva users can access MyVeeva for Patients more reliably during regional system outages, because the system now processes authentication requests through more than one region if the primary region is experiencing an outage. Additionally, mobile users with biometric or PIN authentication enabled can access the app in an offline state automatically during the regional outage.

Commercial

PromoMats

Claims: Auto-Linking in Readiness PanelAuto-on26R1.2

Auto-Linking status is now available in the Document Readiness Panel, providing real-time insight into the progress of Text Asset Auto-Linking when it is initiated on an eligible document. This feature helps provide a clear and consistent way to assess the status of Auto-Linking on a document and to confirm when the process is complete. Learn more about the Document Readiness panel.

Claims: Entry Criteria to Validate References Are in Steady StateConfiguration26R1.2

A new entry criteria, All References are Approved, has been introduced to help ensure references linked to Text Assets are in a steady state. With this entry criteria configured as part of the Text Asset Lifecycle, the presence of a non-steady state reference linked to a Text Asset would prevent the Text Asset from moving to its steady state. Customers currently using the Text Asset Target Relationship Exists entry criteria can transition to using this to validate that all associated references are approved, rather than simply confirming that references have been linked.

eCTD: Auto-On Redline AnnotationsAuto-on26R1.2

The Redline Annotations feature for eCTD Compliance Packages has been enabled in all PromoMats Vaults. With this enhancement, all eCTD Compliance Packages with the Include Linked References setting set to Yes will be generated with redline annotations, rather than the legacy blue links. As part of this feature, the Add Annotations from Vault Links Application setting has been removed.

Claims: Remove Auto-Link on Initial Upload FlagAuto-on26R1.2

The Auto-Link on Initial Upload Admin checkbox has been fully removed, as detailed in this announcement. Customers can now use the Text Asset Auto-Linking Settings page to configure the specific document lifecycle states that trigger the Auto-Linking process following a document upload.

Claims: Deep DeleteAuto-on26R1.2

Deleting a Text Asset record now automatically deletes all related child records. Previously, if a Text Asset had any related child records, users were required to manually delete each of those before the parent record could be deleted. If a custom child object has been added to a Text Asset, its deletion rules must be set to Cascade delete children records to enable this functionality.

Medical

MedComms

Scientific Statements: Auto-Linking in Readiness PanelAuto-on26R1.2

Auto-Linking status is now available in the Document Readiness Panel, providing real-time insight into the progress of Scientific Statement Auto-Linking when it is initiated on an eligible document. This feature helps provide a clear and consistent way to assess the status of Auto-Linking on a document and to confirm when the process is complete. Learn more about the Document Readiness panel.

References in SCP UIAuto-on26R1.2

References for Scientific Statements can now be managed directly from the Scientific Communication Platform (SCP) UI. A new dialog enables users to add or remove references and anchors for individual Scientific Statements.

Scientific Statements: Entry Criteria to Validate References Are in Steady StateConfiguration26R1.2

A new entry criteria, All References are Approved, has been introduced to help ensure references linked to Scientific Statements are in a steady state. With this entry criteria configured as part of the Scientific Statement Lifecycle, the presence of a non-steady state reference linked to a Statement would prevent the Statement from moving to its steady state. Customers currently using the Statement Link Target Relationship Exists entry criteria can transition to using this to validate that all associated references are approved, rather than simply confirming that references have been linked.

Auto-on SCP UIAuto-on26R1.2

The Scientific Communication Platform (SCP) UI is now enabled automatically in all MedComms Vaults. This enhancement provides an improved experience for SCP users in MedComms, with all Communication Platform records using the application-specific interface by default. With this feature, the Enable Communication Platform UI Application setting has been removed, as detailed in this announcement.

Scientific Statements: Deep DeleteAuto-on26R1.2

Deleting a Scientific Statement record now automatically deletes all related child records. Previously, if a Scientific Statement had any related child records, users were required to manually delete each of those before the parent record could be deleted. If a custom child object has been added to a Scientific Statement, its deletion rules must be set to Cascade delete children records to enable this functionality.

MedInquiry

New Case Management User InterfaceConfiguration26R1.2

This release introduces the new Case Management UI, a new app page that helps users efficiently manage Medical Information cases with all Case and Case-related records available on one page. Admins can now configure the layout and fields displayed within this interface, ensuring that teams have a streamlined experience when logging cases, selecting contacts, and assembling and sending responses to HCPs.

Editable Standard Formatted Output TemplatesAuto-on26R1.2

This release includes a Platform enhancement that allows the Label, Output Format, and template file to be editable for standard Formatted Output templates, which were previously not editable. In MedInquiry, this applies to the Case Report for Attachment (case_report_for_attachment__v) template.

Quality

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

Batch Release

Configurable By ExceptionConfiguration26R1.2

With this release, when a Check Requirement’s Including Genealogy is set to By Exception, users can select Disposition Decision values in the Release Exception Decision field to determine when Vault should skip a related record. For example, prior to this feature, Vault skipped an item only when the Disposition Decision was Accepted. Now, this can be set to Accepted and Conditionally Accepted, or any other custom decision. When this field is null, Accepted will be skipped for backwards compatibility with existing behavior.

Item Creation Status BannerAuto-on26R1.2

A warning banner is now displayed on the Batch Disposition Execution Page when Batch Disposition Item creation is still in process or has failed. When item creation is complete, the banner will update with a link to refresh the page and view the completed items.

QMS

Qualification Support for LIMS & Batch ReleaseAuto-on26R1.2

This release introduces an enhanced qualification data model that expands support for LIMS and Batch Release. The data model changes will enable qualification approvals for any type of Material (Raw, Intermediate, Active Substance, and Drug Product) to be tracked against finished products and markets. These enhancements help organizations make informed decisions about releasing batches and defining material test requirements.

Audit Room: Configurable Lifecycle StatesConfiguration26R1.2

With this release, Audit Room now supports modifying state labels and adding additional state lanes. To improve organizational consistency and clarity, Admins can now relabel standard lifecycle states and state types. Additionally, the Audit Room now supports custom lifecycle states and state types, removing previous validations that limited the Inspection Request Lifecycle to standard states and state types.

A new Inspection Audit Room Owner application role enables designated users to configure the Audit Room experience. These users can adjust the display and order of Inspection Request Lifecycle states displayed in the Audit Room through a new configuration interface.

Audit Room Owners can now tailor the visual board to reflect their specific business process and include up to ten lifecycle state lanes, allowing Audit Room Owners to prescribe the exact order of state lanes in the Audit Room user interface.

This feature enables alignment with organizations’ internal terminology, allowing for more complex business processes and improved clarity, consistency, and overall management of inspection processes.

Audit Room: Publish Inspection Request from Any Lifecycle StateAuto-on26R1.2

This feature removes the validation that requires users to move an Inspection Request into the Fulfilled state prior to moving it into the Published state. Users can now publish Inspection Requests from any lifecycle state. This allows customers to tailor the Audit Room to meet their needs and reflect their specific business process.

Audit Room: Multiple Scribe NotesAuto-on26R1.2

The Audit Room now supports multiple Scribe Notes, expanding beyond the previous single-note limitation. This enhancement allows audit teams to segment documentation by day, inspector, or specific area of scope, ensuring every detail of an inspection is captured with precision.

A new standard document classification, Scribe Notes (scribe_notes__v), is now available to allow users to attach multiple Scribe Note documents to a single Inspection record through the Audit-Document join object, in addition to the existing standard Scribe Notes field on the Audit object.

This feature also introduces a dedicated dialog in the Audit Room that users can open to view a list of up to 100 Scribe Note documents associated with the record, with pagination and scrolling for easy navigation. Selecting a document opens it in a new window for quick review.

Display Record Count for QMS SectionsAuto-on26R1.2

To improve data visibility, Vault now displays real-time record counts for several QMS-specific sections. This allows users to immediately see the volume of associated data without needing to manually scroll or expand the section. The record count is now available for the following sections:

• Action Steps
• Notification Recipients
• Reason for Change History
• Record History
• Related Event
• Risk Builder

By aligning the behavior of these QMS sections with other Vault areas that already utilize record counts, this update streamlines the user interface and ensures a predictable and intuitive navigation experience across the entire platform.

This feature is automatically enabled for all Vaults.

Create Related Record: Copy Custom Fields for Referenced RecordsAuto-on26R1.2

With this release, the Create Related Record functionality is enhanced to ensure a more seamless data transfer during record creation. For Related Record Configurations that include reference records, the Create Related Record action now accurately copies all existing custom field values from records referenced by the source record to the target reference records, prioritizing the existing data over system-defined default values. Prior to this release, custom fields on target reference records would populate with default values, even if the source reference record contained different data.

Veeva AI for Quality

Complaint Agent & Deviation Agent: User Experience ImprovementsAuto-on26R1.2

This feature enhances the user experience for Investigation and CAPA Plan summary generation to allow users to navigate away from the record during narrative summary generation. When users navigate back to the record after summary generation is complete, they can review and save the generated summary. This feature also improves the readability of generated summaries.

Complaint Agent: Medtech ComplaintsConfiguration26R1.2

This feature expands the Generate Investigation Summary and Ask Questions capabilities to Medtech Complaints. With this enhancement, Vault can now provide on demand, narrative-style summarizations of the Investigations related to Medtech Complaints, providing the user with an opportunity to review, modify, and save the summarized content to the record. Beyond summarization, the Complaint Agent can now also answer questions about a Medtech Complaint via the Veeva AI Chat interface.

Surveillance

VPS: Generate AER SnapshotConfiguration26R1.2

Vault Product Surveillance now generates a point-in-time snapshot of relevant data when submission documents are created, ensuring that the information leveraged in the Vault UI and PDF and XML submissions are synchronized and immutable post-approval. This allows users to view historical versions of submitted AERs in a read-only view directly within Vault, rather than needing to pull down prior versions of generated PDFs or XMLs to view or compare changes over time.

The VPS: Generate Submission Documents action is at the heart of this update, as it now additionally captures relevant data at the time of generation so that it can be stored and used in the future when this version of the AER is viewed within Vault. Best practice flows will ensure that once these submission documents are generated, the UI of the AER will be read-only in Vault unless the AER itself is returned to a Drafting state.

VPS: Early Adopter FeedbackAuto-on26R1.2

This release introduces several smaller changes to add support for a Related Adverse Event Reports data grid in H10 and AER management regarding Concomitant Products.

Section H10 will now provide the ability to include a data grid referencing either related AER numbers (if the AERs are present in the system) or a text field for a manually captured AER Report Number if the reference exists outside of the Vault.

The concomitant product enhancements include adding a new field to capture concomitant product text for PMDA, EU/MIR, and eMDR, as well as updated logic to intelligently source information either directly from the system if it exists (if Concomitant Product Available in System is true) or from this new dedicated field, if not.

Training

Some Training features additionally apply to Study Training. See Clinical Operations: Study Training.

No Due Date Matrix TrainingAuto-on26R1.2

Training Administrators can now assign training to Learners that must be completed before they perform specific tasks, but without requiring a fixed due date. This feature allows you to create “at-your-own-pace” Training Assignments, providing greater flexibility in how you manage Learner requirements. This feature benefits Training Administrators by simplifying the creation of optional training, and Learners benefit from accessing necessary materials without the pressure of an immediate deadline.

Previously, Training Assignments required a due date, calculated from the Training Requirement’s duration values. This new enhancement allows for a “No Due Date” configuration, so that you can provide Learners with information that is required for compliance or Curriculum completion, but does not have a strict completion timeline.

• You can activate the No Due Date value in the Training Requirement Due Date Calculation picklist, corresponding to the Due Date Calculation field on Training Requirements.
• When Vault creates a Training Assignment for a “No Due Date” requirement, it sets the assignment’s Due Date Timing accordingly and leaves the assignment’s Due Date blank.
• Assignments without a due date are still included in Curriculum completion calculations, ensuring Learners fulfill all necessary training to complete their curriculum.

When a Learner is assigned a Curriculum that requires a duration-based due date for a requirement they already have as a “No Due Date” assignment, Vault automatically updates the blank due date to a specific date based on the new configuration.

Validation Management

Test Authoring Interface Experience ImprovementsAuto-on26R1.2

This release includes several improvements to the Test Authoring interface:

• Loading the authoring interface and saving steps are faster.
• Field validations (required and minimum and maximum length) are actively handled when interacting with steps, rather than producing an error when saving.
• The maximum number of prompts shown on the step horizontally is also increased to mirror the layout of steps on Execution and Review interfaces.

This feature is auto-on and visible to all users who interact with the Test Authoring interface.

LIMS

Design Data Builder: Chart DefinitionsAuto-on26R1.2

Spec Data Builder now allows Design Data Admins to configure various chart types, including control charts and regression analysis, directly through a centralized interface. Previously, this option was not available in the Design Data Builder.

Data Model UpdatesAuto-on26R1.2

This update introduces the following data model changes:

• The following standard fields have been added to the Spec Data Sample Action object: Externally Tested?, Testing Location, Auto-Dispose?, Planned Disposal Interval, Reported Name
• The Lab Consumable Family object now has a lifecycle
• The Minimum, Maximum, and Decimal fields are now editable on Lab Test Definition Input, Lab Test Definition Variation Input, and Lab Test Input objects

Lab Consumable Family Object LifecycleAuto-on26R1.2

This feature adds a standard lifecycle to the Lab Consumable Family object.

Spec Data Builder: Option to Edit Fields on Sample ActionAuto-on26R1.2

For Select Actions (like Aliquot or Test Actions), there is now an Edit Metadata button in the UI. This opens the Action record in a new browser tab (VOF), allowing the user to quickly set metadata field values without cluttering the main Builder interface. Additionally, the Reported Name field is now directly visible and editable on the Test Action card within the Spec Data Builder.

Test Definition Result: Formatting Options Can Be OptionalAuto-on26R1.2

Previously, LIMS enforced Precision Type and Precision Number as required fields via standard validation rules. This feature allows Admins to inactivate these rules, and thus save a Result or Variation Result without applying formatting rules.

Spec Data Builder: Formatting Options Now EditableAuto-on26R1.2

In the Spec Data Builder, the Result Format section on the Criteria card is now interactive, allowing Admins to view and update the formatting options directly.

This feature loosens the rigidity around formatting fields. While Notation cannot be blank (it will default to Standard if unspecified), Admins may now leave the other fields blank. Admins can also use specific valid combinations, such as populating just the Rounding Rule and Precision Rule, or populating all fields.

Upper Level of Quantification (ULOQ)Auto-on26R1.2

This feature expands on LOD/LOQ with an Upper Level of Quantification (ULOQ). While LOD/LOQ cover the smaller range of possible measurement values, ULOQ provides the means to change how measurements above acceptable ranges are reported, displayed, and calculated. Design Data Builder has been updated to support the individual use of LOD, LOQ, and now ULOQ for Lab Test Result Definitions.

Test Execution: Display Spec CriteriaConfiguration26R1.2

This feature allows Design Data Admins to display detailed product specification descriptions to Lab Analysts directly within the Test Execution and Sample Results Entry (SRE) UI.

Test Execution: Updated Exception Icon Hover DisplayAuto-on26R1.2

Because some spec descriptions can be very long, the existing Criteria icon hover tooltip has been redesigned to prevent text from clipping off the screen. The new tooltip shows a maximum of three Criteria, truncates descriptions on the third line, and includes a new View Details link that opens a dialog containing the full, untruncated text for all applicable Criteria.

Test Execution: Optional Expected AmountAuto-on26R1.2

For some cases, Analysts do not have to enter an Expected Amount for Consumables. In this case, the Expected Amount can be left blank in the Test Definition and thus is not required in LIMS.

Assets & Consumables StandardizationAuto-on26R1.2

This feature standardizes commonly used components (objects, object types, lifecycles, lifecycle states, workflows, and fields) across Assets and Consumables. No new logic is introduced as part of this update. Establishing these standards provides a foundation for building future functionality in the Assets and Consumables domain.

Regulatory

RIM Publishing

Automatic On-Demand Validation for Submission Validation Version ChangesAuto-on26R1.2

When Publishing users select a new Validation Criteria Version field value, the system will now automatically trigger on-demand validation. Validation will be triggered upon saving the new value on the Submission record, and only when Enable Continuous Publishing is set to Yes.

What’s New

Previously, publishers would need to remember to revalidate in-progress submissions if the previously selected validation criteria was updated. Now, the system will automatically trigger the action.

Key Benefits

When validation criteria is mistakenly chosen, or when new validation criteria becomes required while submissions are in-progress, the automatic validation trigger allows for the most current validation results to be made available.

Taiwan eCTD 3.2 (TW 2.1) DTD 2.0Configuration26R1.2

Submission Publishing now supports the TFDA eCTD v2.1 specification for publishing and validation of Taiwanese submissions.

Key Benefits

The updates will ensure that customers publish and validate compliant Taiwanese eCTD v2.1 submissions to TFDA

Additional Considerations

The TW eCTD v2.1 format will be required for new Marketing Authorizations from 01 July 2026.

RIM Publishing, RIM Submissions Archive

eCTD 4.0 Viewing: Stylized Submission Unit XMLAuto-on26R1.2

Regional details for eCTD 4.0 submissions are now presented in a user-friendly rendition that displays metadata and details that are not included in the Submissions Archive Viewer grid matrix. The stylized Submission Unit XML will be viewable for all currently supported eCTD 4.0 regional DTD versions, though each supported region will include its own set of information in the display.

What’s New?

Submission Administrative Information (SAI) for eCTD 4.0 submissions now displays in a stylized rendition, replacing the machine-readable plain text Viewable Rendition available previously. The new stylized rendition will be available via the Submission Administrative Information section of the Submission record layout, and both the Embedded Document Viewer and Mini-Browser within the Submissions Archive Viewer.

Consideration: For final, imported or published submissionunit.xml files that display with a plain text rendition, open the document in the Mini-Browser, then use the Re-render Document action. This will re-render the submissionunit.xml plain text rendition, replacing it with the stylized rendition.

Key Benefits

The stylized Submission Unit XML rendition provides a seamless viewing experience and aligns the SAI display with that of eCTD 3.2 submissions. The stylized rendition will be available for both imported submissions and those generated by Veeva Submissions Publishing.

RIM Registrations

IDMP Output Record PurgeAuto-on26R1.2

To maintain database hygiene and system performance, Vault now includes an automated cleanup process for Identification of Medicinal Products (IDMP) output records. For a fully built-out Medicinal Product, Vault can generate up to 1.6 million records across 45 objects. This feature ensures these redundant records are purged once the authoritative FHIR message is secured.

What’s New?

Vault manages record cleanup through a two-tiered process:

• Immediate purge: Vault purges all related Product Data Submission (PDS) output records immediately after a FHIR message is successfully generated.
• Daily maintenance (90-Day backstop): A daily IDMP Output Cleanup job runs to catch any old records or records missed during immediate purges.
  • Logic: The job purges records if the related PDS Medicinal Product Element has not been modified in 90+ days or when the Marked for Deletion (marked_for_deletion__v) field is Yes.
  • Failure handling: If an immediate cleanup fails, Vault flags the record by setting the Marked for Deletion field to Yes.
• Failure notifications: When a cleanup job fails, Vault notifies the Vault Owner and includes a link to Admin > Operations > Job Status > History in the notification.

Key Benefits

• Performance Stability: Prevents high-volume IDMP data from impacting system responsiveness over time.
• Authoritative Records: Establishes the structured FHIR message as the single source of truth for submission history.
• Troubleshooting Safety: When the FHIR Message Generation job is not successful, IDMP output records are not immediately purged. Instead, they are preserved under the Product Data Submission for manual review and are only removed by the automated daily cleanup job once their related PDS Medicinal Product Element record has not been modified in over 90 days.

Additional Considerations

• Availability: This feature is provisioned to all RIM Registrations Vaults. The new Marked for Deletion field is provisioned as inactive. This field should be activated to support the purge operation, but it does not need to be added to the Product Data Submission object page layout. The daily IDMP Output Cleanup job runs daily at 12:00 AM EST by default, however you can modify the schedule.
• Operational guardrails: To prevent data conflicts, Vault blocks new IDMP data generation while a cleanup job is in progress (applies to both individual and bulk jobs).

Link Packaging to MP-Registration Bulk ActionAuto-on26R1.2

What’s New?

This feature introduces the ability to execute Link Packaging to a Medicinal Product Registration (MP-Registration) as a bulk action, allowing you to enrich MP-Registration records at the packaging level at scale. This update supports the EMA’s requirement for both XEVMPD and IDMP data to be submitted at the packaging level. When you execute this as a bulk action, the system processes records sequentially in batches of 500 to prevent race conditions.

How to Execute Link Packaging to MP-Registration as a Bulk Action

1. Navigate to the Registered Packaging object.
2. Select the desired records for enrichment.
3. From the All Actions menu, select Link Packaging to MP-Registration.
4. Review the confirmation dialog and click Finish.
5. Vault sends an email notification with the results once the process is complete.

Key Benefits

• Scale and efficiency: Facilitates the enrichment of data in RIM Vaults where XEVMPD or IDMP data is already managed.
• Automated notifications: Vault sends a notification to the user who executed the bulk action upon completion of each batch.
• Detailed reporting: Notifications include summary results and CSV files for both successes and failures.
• Regulatory compliance: Helps maintain the granularity required for EMA structured data reporting.

Additional Considerations

• Sequential processing: If you include more than 500 records in a bulk action, Vault runs the jobs one at a time until all batches are complete.
• Success criteria: A record is categorized as a success if the job runs successfully, even if it results in no changes to the Medicinal Product Registration records.
• Failure logs: For any records that fail to process, Vault includes the specific error details in the results CSV.
• Permissions: Ensure your security profile grants the necessary permissions to execute bulk actions on the Registered Packaging object.

Enhanced IDMP Support for UDI-DIAuto-on26R1.2

IDMP requires the Unique Device Identifier (UDI-DI) at the medical device model level recorded in EUDAMED for drug-device combinations. This feature improves how you manage and report medical device identifiers within the IDMP data standard for these products.

Vault now allows for more than one of the same devices to be included in packaging by shifting data storage from the Product record to specific Packaging Product Variant records.

What’s New

• New Device Identifier Fields: Vault provisions new fields to manage identifiers at the individual level:
  • device_identifier__v: A text field on the Packaging Product Variant(packaging_product_detail__rim) object.
  • device_identifier2__v: A destination field on the PDS Container Reference Item(idmp_container_reference_item__v) object.
• Updated Aggregation: The IDMP aggregation algorithm now sources the device_identifier2__v field from the device_identifier__v field.
• Fields Replacement:
  • The new device_identifier2__v field replaces the device_identifier1__v Data Carrier reference on the PDS Container Reference Item.
  • The IDMP data aggregation algorithm no longer sources the UDI-DI from the basic_udidi__v field on the Product record, but instead pulls it from the new text field on the Packaging Product Variant.
• Repeating Records: You can now enter multiple devices with the same Product and Product Variant combination as repeating Packaging Product Variant records with unique identifiers.

Key Benefits

• Improved granularity: Shifting data storage from the general Product level to specific Packaging Product Variant records allows Vault to accurately track multiple identical devices in a single package.
• Standard alignment: These updates better support the device identifier granularity required by the IDMP data standard and EUDAMED.

Additional Considerations

• Specific data requirements:
  • To include devices in the IDMP output, you must create the device as both a Packaging Product Variant record and a Registered Product related to the drug Registration.
  • In both records (Packaging Product Variant and Registered Product), you must set the Co-Packaged or Integral checkbox to Yes.
• Data Migration: Migration is not in scope due to the limited number of Data Carrier records where the Data Source is EUDAMED.

Important: Aggregation behavior changes automatically in existing Vaults configured for IDMP. The new device_identifier__v and device_identifier2__v fields are provisioned as inactive, so Admins must enable them.

Support for User Groups in Registration Verification WorkflowConfiguration26R1.2

This feature enhances Registration Verification by supporting user groups and manual participant selection within the workflow.

What’s New?

The Registration Verification workflow now supports the Allow workflow task owners to select participants and Use Vault user group as participants settings. These enhancements provide greater flexibility for the four-eye principle review process.

Key updates include:

• Participant selection: When the Allow workflow task owners to select participants setting is enabled on the workflow and the Select Verification Groups Admin setting is configured, Vault ignores the Select Verification Groups setting.
• User group support: When the Use Vault user group as participants setting is enabled, Vault ignores the Select Verification Groups Admin setting.
• Workflow visibility: The Verification Workflow Details section now displays the participants selected for the initial workflow task.

Key Benefits

• Enhanced Flexibility: Leverage standard Vault user group configurations for more granular control over registration change reviews.
• Process Efficiency: Dynamically identify correct reviewers during the process by allowing workflow initiators or task owners to select participants.
• Transparency: View assigned participants directly within the Regulatory Objective Details.

Additional Considerations

• Initial task limitations: The Allow workflow task owners to select participants setting does not apply to the initial task in a workflow.
  • When the initial task is assigned to the workflow owner group, Vault assigns the task to the workflow owner and indicates this in the Regulatory Objective Details. Vault displays the following message: “This workflow will be assigned to the workflow owner.”
• Unsupported configurations: If the verification workflow is configured with the Verify Registration Data task as the initial task, users cannot submit Manage Registered Details (MRD) or advance to the next page.
  • In this scenario, Vault displays the following error: “The verification workflow configuration is not supported. The workflows will not be generated based on your current settings. Please contact your administrator.”
• Configuration errors: When Vault cannot determine initial participants, it displays the following error: “Unable to determine initial participants for workflow. This configuration may not be supported.”

Allow Disabling of Event Change Action ValuesAuto-on26R1.2

Admins can now inactivate Event Change Action picklist values used in the Create & Manage Event Details action. This update provides flexibility to control which action types are available for selection.

What’s New?

In this release, Vault Admins can inactivate specific values within the Event Change Action picklist. This allows you to restrict the options users see when they run the Create & Manage Event Details action. For example, you can hide actions like Replace or Update and only display Add and Withdraw.

Key Benefits

• Process control: Limits users to specific actions that align with your organization’s business requirements.
• Improved adoption: Reduces user confusion by removing options which are not supported by your business process from the interface.
• Targeted selection: Ensures users only see relevant values based on your configured picklist settings.

Additional Considerations

• Action behavior: The underlying behavior and associated validation for the Create & Manage Event Details action have not changed.
• UI visibility: This change only affects which values are available for selection; it does not impact existing data.
• Note: We recommend reviewing your current business processes before inactivating picklist values to ensure users still have access to necessary actions. At least one picklist value must be active for the Create & Manage Event Details action to be executed.

Wizard Updates for Enhanced Handling of Local DifferencesAuto-on26R1.2

Vault RIM now includes updates to various Registrations wizards to improve the handling of Active Substance, Inactive Ingredient, and Manufactured Product Dosage Form details on Events, Registrations, and other local records. These updates ensure data flows accurately across regulatory transactions and local regulatory information when you use the local differences feature to capture local Product Variant attributes.

What’s New?

Suppressing Special Records in Create Event Details

Admins can now set the Suppress Special Records attribute to Yes on the Event Change Detail Field subcomponent. This attribute is available for Event Change Details referencing the Event Inactive Ingredient object and Event Change Detail fields referencing the Inactive Ingredient field.

When you set this to Yes, the Create Event Details wizard dropdown filters out any Inactive Ingredients with a non-blank value in the Special Record Classification field. Additionally, Vault does not create or propose records for these inactive ingredients, ensuring that Compendial or Non-Compendial records are only created for Manufacturing Details where appropriate.

Updating Join Field Logic for Content Planning

Validation logic for join field handling is updated in the Create Related Records and Update Local Regulatory Information wizards. Vault now only considers target relationship records where Use for Content Planning is set to Yes.

This update ensures join fields for local Inactive Ingredient, Clinical Study, and Extended eCTD Keyword relationships are set correctly, preventing duplicate record creation.

Enhancing Create Registrations & Manage Registered Details

The Create Registrations and Manage Registered Details wizards now use updated validation logic to ensure only relevant records are added to a Registration based on the country’s requirements:

• Registered Active Substances: Vault matches the Active Substance Strength or Active Substance Name when the value is a valid preferred value or local exception for the registration’s Country. At least one Registered Product on the Registration must match the referenced Product Variant from the Product Variant Active Substance (PVAS).
• Registered Inactive Ingredients: Vault matches the Inactive Ingredient Strength or Inactive Ingredient Name when the value is a valid preferred value or local exception for the country. At least one Registered Product must match the referenced Product Variant from the Product Variant Inactive Ingredient (PVII).
• Registered Manufactured Dosage Forms: Vault constrains and adds these only when they are a valid preferred value or local exception for the registration’s Country.

When a Registered Product is a complex product, Vault also uses the Product Variants from its product components in the matching logic.

Key Benefits

• Improved data accuracy: Ensures Vault creates the correct data on Registrations and Events without the need for manual configuration workarounds.
• Reduced duplication: Prevents duplicate records by focusing on Content Planning details for specific relationship fields.
• Process efficiency: Eliminates the need for users to ignore specific error messages, leading to a smoother end-to-end regulatory process.

Additional Considerations

• Enablement: This feature is auto-on, but some configuration is required.

RIM Submissions, RIM Submissions Archive

Active Dossier: Exclude Submission Country from GenerationAuto-on26R1.2

What’s New?

Vault RIM now allows you to exclude specific submission countries from Active Dossier Item Detail (ADID) creation. This is particularly useful for EU Centralized Procedures where you may need to include all EMA countries in a submission but only wish to generate EU-level ADIDs.

Vault now includes an Exclude from Active Dossier Generation yes/no field on the Application Country and Submission Country objects. When this field is set to Yes on a Submission Country, Vault ignores that country during automated Active Dossier (AD) generation.

To further automate this process:

• Field Defaulting: When you set the value on an Application Country, Vault defaults that value to the corresponding Submission Country record created via the Submission Wizard or Create Related Records Wizard.
• Procedure Constraints: You can use the new Exclude from Dossier by Constraint field on the Country object alongside Procedure Type Country Constraint records. When configured, Vault automatically sets Exclude from Active Dossier Generation to Yes on Application Country records based on the procedure type, such as a Centralized Procedure.

Key Benefits

• Simplified EU Management: Efficiently manage Centralized Procedures by generating only required ADIDs while maintaining a complete list of submission countries for tracking.
• Increased Automation: Reduce manual data entry by defaulting exclusion settings from the application level to the submission level.
• Improved Accuracy: Ensure ADID creation consistently aligns with specific procedure types through automated country constraints.

Additional Considerations

• Enablement: This feature is auto-on, but some configuration is required.
• Manual Generation: This exclusion logic only applies to automated generation. If you manually drag and drop a document into the Active Dossier Viewer, Vault creates ADIDs for all submission countries regardless of the exclusion field value.
• Layout Updates: Vault provisions updates to the application_country_layout__v and submission_country_layout__v standard layouts as part of RIM Core Data Model changes.

Active Dossier: Uniqueness Key Robustness (Part 2)Auto-on26R1.2

Vault has improved the Active Dossier Uniqueness Key calculation to enhance performance and prevent the creation of duplicate Active Dossier records during generation. As part of this enhancement, Vault introduces system safeguards that prevent users from deleting Application, Submission, and Country records if they are actively referenced on existing Active Dossier Item Detail records.

Key Benefits

• Maintaining Data Integrity: Active Dossier Item Detail records capture the context of a document within a country using regulatory transaction references. Preventing the deletion of related foundational records avoids orphaned records.
• Ensuring Accurate Automated Calculations: Vault scopes automated calculations, such as the Latest for Authoring (LFA) value, based on Application, Country, and Product metadata. Maintaining these records ensures LFA and document status calculations remain accurate.
• Improving System Performance: Refining uniqueness key calculations and preventing duplicates improves the speed of Active Dossier generation and updates.

Additional Considerations
This update is a backend enhancement. No additional Admin configuration is required.

Safety

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

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

Safety

Web Intake FormsConfiguration26R1.2

To facilitate structured data intake for spontaneous adverse event reporting, Veeva Safety introduces Web Intake Forms, which enable the direct collection of structured adverse event details from consumers and service providers managing post-marketing programs. This streamlined intake process reduces manual entry and ensures data consistency from the point of origin. 

Key capabilities include:

• Configurable Web Forms: Allows Admins to design and deploy customized web-based forms tailored to specific programs or reporter types, capturing correct information upfront.
• Direct-to-Vault Intake: Streamlines submissions directly into the Safety Inbox as structured records, minimizing the need for manual transcription from PDFs and emails.
• Standardized Data Mapping: Enhances data quality by enforcing field-level validation at the source, leading to faster triage and more efficient case processing.

These updates bridge the gap between external reporters and the Veeva Safety database, reducing administrative overhead and accelerating the timeline for case processing.

Safety Rules Troubleshooting Tool for Localized CaseAuto-on26R1.2

To streamline the validation of specialized regional requirements, the Safety Rules Troubleshooting tool has been expanded to support Localized Cases, providing full visibility into regional rule evaluations. Previously, this diagnostic tool was limited to global Case records, limiting visibility into regional reporting logic, such as Japan reportable cases or domestic cases with a local localization scope.

With this release, the troubleshooting tool has been updated to accept both standard Case IDs and Localized Case IDs. When troubleshooting a Localized Case ID, Vault executes a detailed, asynchronous log of every registration, Safety Rule Set, and Safety Rule Parameter processed to provide technical insight into why a specific localized assessment passed or failed a reporting requirement.

Key capabilities include:

• Japan Localized Reporting Log: Vault now provides a dedicated reporting log for Japan scenarios that can be downloaded as a CSV. This log includes critical data points such as the Reporting Scenario, Destination ID, Rule Name, and the specific Localized Case Assessment IDs that passed or failed.
• Transmission Profile Selection Reasons: For all submission evaluations, the troubleshooting log now includes a Transmission Profile Selection Reason column. This identifies the exact logic Vault used to choose a profile, such as Product Registration, Study Registration, Profile Scope Matching, or Fallback logic.

Case Link ReasonAuto-on26R1.2

Veeva Safety now provides a standardized way to define relationships between linked cases, improving traceability and clarity. This update removes the need for custom fields and ensures that important context such as shared literature sources or familial relationships is captured consistently and in alignment with international regulatory standards.

Key enhancements include:

• Standardized Link Reasons: A new Link Reason field has been added to the Case Relationship object, providing pre-defined values for common scenarios including Parent/Child, Same Patient, Same Reporter, and Same Literature Article.
• Regulatory Compliance Alignment: The introduction of this standard field supports compliance with ICH and GVP Module VI (C.1.10.r) requirements for identifying and evaluating related reports together.
• Immediate UI Visibility: To streamline the review process, the Link Reason column appears by default in the Related Cases section of the standard Case layout, allowing users to understand case connections at a glance without navigating to sub-records.
• Data Persistence: Vault ensures that link reasons are preserved during deep copy actions, such as when creating a follow-up Case via a user action, maintaining the integrity of the relationship history.

FDA MedWatch 3500A: September 2025 VersionConfiguration26R1.2

With this release, Veeva Safety introduces support for the September 2025 version of the FDA MedWatch 3500A form. Vault incorporates the required data model for this latest version, which is available for preview, submission, and distribution of ICSRs for drug, biologic, medical device, and clinical trial cases. This update includes an application setting that enables Admins to manage the version cutover independently. Previously, Admins had to contact their Veeva Representative to activate a specific version of the form. The application setting defaults to the version of the form your Vault currently exports. If you want to continue with the same version, you do not need to take any action.

Configurable Event Reported Verbatim on ImportConfiguration26R1.2

Streamlining how adverse events are captured from international data sources is critical for global safety reporting. This update introduces refined logic for populating event fields when the E2B(R3) or JSON file includes an English translation value but is missing native language terms. With this release, Veeva Safety ensures that if the (E.1.1.1a) event fields are blank, Vault automatically leverages the Event Reported (English) (E.i.1.2) value. This reduces manual data entry and ensures consistency across global transmissions.

Key capabilities include:

• Automated Data Mapping: If both the native event term (E.i.1.1a) and the language code (E.i.1.1b) are missing, Vault maps the English translation (E.i.1.2) into the Event (Reported) field and defaults the language to English (ENG).
• Configurable Admin Control: A new Transmission Profile setting controls this logic. In Vaults with the Enable Localization-based Mapping on Import setting enabled, Vault evaluates specific E.i elements to determine the best available data source.
• Visual Source Transparency: A new visual indicator icon appears on the Source Data Panel next to the Event Reported field. Users can hover over this icon to see the tooltip stating Import from Event Reported (English), providing clear lineage for the data.
• Preservation of Coding: To maintain data integrity, this automated logic does not override any MedDRA coding already performed on the record.

PMDA Comments AssistanceConfiguration26R1.2

To streamline compliance with PMDA reporting requirements for section J.2.11 (Other References), Veeva Safety now captures more detailed expectedness information on localized records. This enhancement makes the context for unexpected events, such as whether a term is listed on the datasheet or considered unexpected due to its seriousness, clear through additional information on localized records.

Key enhancements include:

• Granular Localized Data Model: For added clarity, Vault populates the reason for an expectedness evaluation, such as Unexpected Due to Seriousness, in the new Expectedness Details field on Japan Localized Case Assessments.
• Localized MedDRA Term Mapping: Based on the Event (LLT) on the global Case, Vault now populates a Localized Event (LLT) on Japan Localized Case Adverse Events, providing the necessary Japanese MedDRA translation for localized regulatory workflows.

Partially Completed Follow-up QuestionnairesConfiguration26R1.2

With this release, Veeva Safety introduces the ability to capture partially completed follow-up questionnaires abandoned by the reporter. This feature allows organizations to adopt online questionnaires ensuring that Vault brings in all data, including incomplete information.

Key capabilities include:

• Automated “On Behalf” Submission: Vault automatically submits online questionnaires on behalf of the respondent, ensuring that all entered data is captured.
• Configurable Auto-Submission Schedules: Admins can define a specific schedule (measured in hours) after which a distributed questionnaire is considered abandoned and triggered for auto-submission.
• Inbox Item Generation: Vault creates a new Inbox Item for each auto-submitted questionnaire. This allows safety teams to review the partially provided data and determine if further follow-up or case updates are required.

Case Compare: MedDRA Preferred Term MatchingAuto-on26R1.2

When you recode a MedDRA Lowest Level Term (LLT), the Inbox Item to Case Compare and Case Version Compare pages now broaden matching criteria to the Preferred Term (PT) level. Previously, a change in LLT caused Vault to identify the record as New, leading to potential redundant entries. This feature is auto-enabled in all Vaults to increase matches for coding updates, though organizations that prefer strict LLT-level matching can disable this application setting.

Unknown Formulation Product VerificationAuto-on26R1.2

For organizations using Company Product Match Verification and Unknown Formulation Product Selection, when verifying whether a reported product with incomplete data matches a Product Registration Vault previously returned low Product Match Confidence results. Veeva Safety now improves the accuracy of the Product Confidence Match to increase early-stage product identification.

With this release, when a product with an unknown formulation is reported, Veeva Safety performs verification checks against all Product Registrations within the Product Family, rather than failing due to missing registration details. By validating reported data such as Country, Dose Form, and Route of Administration against broader registration records, the update improves matching accuracy and confidence evaluations.

Validation Criteria: Failed Validation Error HandlingAuto-on26R1.2

Veeva Safety now automatically clears failed validation results when underlying data has been removed from a Case. This improves compliance reporting accuracy and reduces manual cleanup by keeping validation results aligned with the current state of Case data, so users do not spend time reviewing outdated errors.

Key enhancements include:

• Automated Obsolete Result Cleanup: The Evaluate Regulatory Conformance action identifies and removes validation results that reference records, such as Case Products, that have been deleted since the previous Evaluate Regulatory Conformance run.
• Redirected Object Support: This update supports scenarios where validations for child objects, such as Case Product Dosage or Case Product Indication, are associated with the parent Case Product. Validation results linked to deleted child records are now properly cleared.
• Unified Validation Consistency: The removal of outdated results is reflected at both the Case level and the Transmission level during the Generate Transmission Document(s) entry action, ensuring a consistent view of data integrity across the submission lifecycle.

Blind Isolation: Simplified Japan Registration UnblindingAuto-on26R1.2

To ensure data integrity and submission accuracy for clinical trials in Japan, Veeva Safety now synchronizes Case Product Registrations (CPRs) following unblinding. This enhancement prevents the creation of duplicate or conflicting registration records that previously occurred when the Isolate Blinded Clinical Trial Information feature generated dual records for blinded and unblinded product states.

Key enhancements include:

• Automated Blinded Record Cleanup: Upon generating new CPRs, Vault identifies and removes existing registrations from when the Case Product was blinded.
• Accurate Unblinded Generation: Vault creates new CPRs specifically for the unblinded Case Product, ensuring that the most current and accurate data is used for regulatory reporting.
• Follow-Up Case Consistency: The simplified registration logic extends to follow-up cases, ensuring that when unblinding occurs later in the case lifecycle, Vault does not preserve orphaned or redundant blinded registrations.
• Manual Entry Support: The robust cleanup identifies and removes even manually created blinded CPRs upon unblinding, maintaining a standardized record state across Vault.

Japan Reporting: Cross Reporting Registration ImprovementsAuto-on26R1.2

To enhance the precision of Japanese regulatory reporting, Veeva Safety now automatically filters out Combination Products during substance-based cross reporting. This update ensures that your registration data remains clean and focused solely on the submittable product entities required by the PMDA.

Key enhancements include:

• Redundancy Prevention: By excluding parent-level Combination Products from cross reporting evaluations, Vault avoids the creation of unnecessary registration records that were previously triggered by shared substances.
• Constituent-Level Accuracy: Vault continues to evaluate individual Product Constituents, ensuring that all standalone Products within a combination are accurately captured for Japanese reporting.
• Reliable Data Mapping: This refinement resolves issues where unexpected combination records appeared in matches, significantly reducing the manual effort required to clean up registration logs.

Japan Reporting: Improved Validations for Blinded Product SubmissionsAuto-on26R1.2

To ensure regulatory submissions for clinical trials in Japan remain compliant without generating unnecessary errors, Veeva Safety has refined the PMDA.G.k.2.3.r.1 validation logic. This update acknowledges that for actively blinded products, substance information is inherently unknown and cannot be reported. By making this validation conditional, Vault prevents “missing data” flags on blinded products, allowing Safety teams to proceed with PMDA submissions more efficiently.

Key enhancements include:

• Conditional Substance Validation: Vault suppresses the PMDA.G.k.2.3.r.1 validation check for any Case Product where blinding is active, preventing false-positive errors for unknown substance data.
• Targeted Compliance: Vault continues to enforce substance data requirements for all non-blinded products, ensuring that open-label or unblinded records maintain full regulatory compliance.
• Reduced Submission Friction: Eliminates the need for manual workarounds or data “placeholders” previously used to bypass substance-related validation errors in blinded clinical trial cases.
• Support for Active Blinding: Directly supports the workflow where actively blinded products are submitted to the PMDA, ensuring Vault reflects the reality of clinical trial data constraints.

Validation Criteria: MFDS Validation Improvements for Device ProductsAuto-on26R1.2

To improve the accuracy of regulatory conformance checks for the South Korean market, Veeva Safety has updated the MFDS validation logic to better distinguish between drug and device products. Previously, several validations did not account for product type, leading to false-positive errors when device cases were missing drug-specific identifiers. This update ensures that device products are no longer evaluated against inapplicable criteria, streamlining the path to submission.

• Product-Aware Validation Logic: Vault now evaluates the Case Product type before triggering specific MFDS validations to ensure that medical devices are only measured against relevant criteria.
• Exclusion of Drug-Specific Data Points: Validation rules for identifiers that do not exist for devices, such as MPID or Substance information, are no longer evaluated or failed for device Products.
• Broad Case Scope Coverage: These logic improvements apply across various reporting scenarios, including Spontaneous Domestic, Foreign Localized, and Other Study cases.

NMPA Validation Criteria: Exclude External ProductsAuto-on26R1.2

Veeva Safety now excludes External Products from the NMPA.G.k.CN.4-1 validation criteria to streamline regulatory reporting for the Chinese market and reduce false-positive errors. This update ensures that case processors are only prompted to provide local registration details for relevant investigational products, while continuing to verify that CTA Approval Numbers are populated for all applicable localized products. By filtering out non-relevant products, teams can focus on resolving valid data gaps more efficiently without unnecessary warnings.

Safety PBRER Case Listing for Summary Tabulation of ADRAuto-on26R1.2

Providing a structured list of cases within aggregate reports is essential for detailed safety analysis and regulatory transparency. Previously, while clinical trial cases included Interval Line Listings, the Summary Tabulation of ADR from Postmarketing Sources lacked a usable case listing, and existing log files were insufficient for deep data analysis.

With this release, Veeva Safety enhances the listing of cases in Safety aggregate reports. Vault now generates a detailed format for the list of cases included in the Summary Tabulation of ADR from Postmarketing Sources, mirroring the format used for Clinical Trial Interval Line Listings.

Key capabilities include:

• Comprehensive Data Access: Vault now generates a dedicated Case Listing for all cases used in the calculations for the PBRER Summary Tabulation, ensuring no data points are left unverified.
• Improved Analytical Utility: Moving beyond basic log files allows teams to perform deeper reconciliations on the postmarketing data used within the report.
• Standardized Reporting Structure: The listing format for postmarketing ADRs now mirrors the OOTB (out-of-the-box) structure used for Serious Adverse Reactions in Clinical Trials, providing a consistent user experience across different PBRER sections.

Responsive UI for Safety Auto-on26R1.2

To provide a modernized and intuitive user experience across varying device sizes, Veeva Safety optimizes the responsive framework introduced with the Responsive UI Platform feature. This transition ensures that critical case processing tools, such as the MedDRA and WHODrug browsers, remain fully functional on smaller screens by displaying full search bars and action buttons during navigation. 

Furthermore, certain complex control fields have been redesigned to render correctly without overlapping data or hiding essential labels. Beyond these functional updates, the UI now features improved label alignment and standardized spacing in key areas like the Patient section of Inbox Items and the Narrative section of Cases to facilitate a faster, more accurate review process. 

To maintain a consistent brand identity, Vault applies the same font across all metrics pages and literature sections, while optimizing comparison tools, such as the Case Version Compare page, to support flexible browser resizing.

Inbox Item Data ArchivingAuto-on26R1.2

To maintain optimal system performance and data organization, Veeva Safety now automatically archives Inbox Items following 180 days of inactivity after promotion. This enhancement ensures that the Inbox remains clear of processed records, allowing intake teams to focus exclusively on active items without the clutter of legacy data. Automating the transition of promoted records to an archived state improves overall dashboard efficiency and streamlines the end-to-end data lifecycle management process.

Automatically Run Early Notification Rules on Case PromotionAdmin Checkbox26R1.2

To assist with regulatory compliance and reduce the risk of missed ICSR deadlines, Veeva Safety provides the ability to evaluate Early Notification rules during the Case promotion process. This enhancement addresses a gap where reporting rules previously failed silently if executed before the asynchronous generation of Case Assessments was complete. 

Vault now provides consistent identification and tracking of urgent early notifications (often due within 24 hours). Key enhancements include:

• Evaluation Trigger: Automatically evaluates Early Notification rules at the precise moment Vault completes Case Assessment generation upon case promotion, ensuring the Safety Rule Engine has access to all necessary data.
• Comprehensive Promotion Support: Applies the automated evaluation to initial Case promotions, as well as follow-up and merge-to-in-flight actions performed through Case Compare.
• Reduction of Manual Overhead: Eliminates the need for Admins to configure complex user actions or entry actions on early Case lifecycle states, which were historically prone to failure due to asynchronous processing.

Email Addresses for Manufacturer SitesAuto-on26R1.2

To meet FDA reporting requirements for medical devices, manufacturer email addresses must often be exported to specific regulatory forms. Previously, the standard Email field was restricted to the Registration Holder object type, which created a data gap when manufacturer details were stored under different organization types. This release expands the availability of the Email field to Sites. This ensures that regardless of how a manufacturer is classified in Veeva Safety, you can capture and map their contact information to FDA device forms.

Exclude Reporter Information by Destination on CIOMS I FormsConfiguration26R1.2

To comply with partner agreements and data privacy standards, organizations often need to withhold specific investigator details when distributing CIOMS I forms externally. Previously, information mapped to Box 25b (such as the investigator’s name, address, and country) was always exported, regardless of the recipient’s privacy requirements.

This release introduces a partner-specific configuration that allows users to redact this information on generated CIOMS I forms. While the investigator data remains fully visible within Veeva Safety for internal use, it is automatically excluded during the transmission process based on the destination’s settings.

Key updates include:

• Partner-Level Privacy Control: A new field for Partners allows organizations to specify whether reporter information should be suppressed for that entity.
• Automated Form Redaction: During transmission generation, Vault evaluates destination partner configuration. If redaction is enabled, Box 25b is blank on generated CIOMS I forms.

Standard FDA eMDR Transmission Profile Document TypeAuto-on26R1.2

With this release, Veeva Safety streamlines the Submission workflow by setting the Outbound Format to FDA eMDR on the standard Transmission Profile for device Submissions to the FDA. This update reduces manual configuration steps and ensures that device-related Submissions consistently include the required documentation for successful electronic Medical Device Reporting (eMDR).

FDA E2B(R3) Relabeled to FDA FAERS E2B(R3)Auto-on26R1.2

To provide clarity across reporting streams, Veeva Safety has updated its naming conventions to better distinguish between the FAERS (drug/biologic) and VAERS (vaccine) reporting systems. With this release, Safety renames the FDA E2B(R3) report to FDA FAERS E2B(R3), assisting users to easily identify and classify documents intended for the FDA’s Adverse Event Reporting System during the submission process. The Vault UI and picklists now match current regulatory nomenclature, reducing the risk of selection errors between reporting channels. While these updates align the Vault interface with the FDA’s latest standards, the underlying document export and data mapping remain the same.

Vault No Longer Creates Gateway ProfilesAuto-on26R1.2

With this release, Vault no longer creates a corresponding Gateway Profile when an Admin creates an AS2 Gateway type Transmission Profile for use with an AS2 Connection. This update modernizes the AS2 connection process for users; there are no changes to the underlying transmission logic or data integrity.

Transmission Profile Creation Limit RemovedAuto-on26R1.2

With this release Admins can create Transmission Profiles without encountering errors previously caused by reaching the Gateway Profile creation limit. Vault now allows for a seamless Transmission Profile creation process, providing Admins with greater flexibility and reducing administrative friction. 

MedDRA International Sort OrderAuto-on26R1.2

The MedDRA Expert Working Group has established an international sort order to ensure System Organ Classes (SOC) terms remain consistently ordered across all languages. Previously, International SOC order was not available in the MedDRA dictionary. As a result, reports typically defaulted to alphabetical order, which led to inconsistent data presentation across different languages or MedDRA versions.

With this release, Veeva Safety introduces the International SOC Sort Order on the SOC terms of the MedDRA dictionary. Reports can utilize this information to ensure that SOCs appear in a standardized, medically logical sequence, regardless of the user’s language or the specific MedDRA version in use.

Key updates include:

• Standardized Sort Order Metadata: Vault now includes the official MedDRA-defined numeric sequence (1-27) for SOC terms within the MedDRA dictionary.
• Automated Dictionary Updates: This sorting logic is automatically applied to existing MedDRA versions and will be maintained for all future dictionary uploads.

Safety Workbench

Advanced Logic for Report Set FiltersAuto-on26R1.2

This feature ensures consistent Workbench Report data analysis and significantly reduces manual effort when managing large report volumes. Veeva Safety Workbench now supports advanced logic for additional Workbench Report Set filters, allowing users to apply complex, ad-hoc filtering criteria across multiple reports simultaneously. 

Dashboard Analysis with View ParametersAuto-on26R1.2

This feature provides the flexibility to focus on specific data subsets in Workbench Dashboards without restricted filtering. Veeva Safety Workbench now supports Workbench View Parameters in dashboards, allowing users to perform complex, calculation-heavy analyses, such as defining multiple periods for disproportionality or setting data cutoff dates for expectedness, directly within a dashboard. Users can dynamically drive SQL joins and layout logic across all dashboard components.

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

Sticky Dashboard TotalsAuto-on26R1.2

This feature enhances data analysis by anchoring total rows to the bottom of Workbench Dashboard Components, ensuring key metrics remain visible while users scroll through detailed records.

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

Dashboards: Embedded User GuidanceAuto-on26R1.2

This feature improves dashboard usability and provides essential guidance by allowing Admins to add static text components to Workbench Dashboards. This enables the display of persistent documentation, such as “Tips and Reminders”, or welcome pages directly alongside data visualizations to provide critical business context.

Safety Signal

MedDRA Query Analysis for FAERS & VAERSConfiguration26R1.2

Veeva Safety Signal now supports running Signal Calculations at the MedDRA Query level using FAERS and VAERS data. This feature enables aggregated analysis across external datasets to improve signal detection accuracy.

Safety Signal & SafetyDocs

Signal Review SchedulingConfiguration26R1.2

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

SafetyDocs

PVA Effective Date AutomationConfiguration26R1.2

Managing the timeline of Pharmacovigilance Agreements (PVAs) requires coordination between administrative completion and regulatory activation. Previously, activating a PV Agreement was often a manual task, which created a risk of non-compliance if the status wasn’t updated exactly when the agreement became effective.

With this release, Veeva SafetyDocs automates lifecycle management for PV Agreements based on future-dated effectiveness, ensuring seamless transitions and reducing the administrative burden of manual status updates. PVA Managers can now finalize records in advance, allowing Vault to transition PV Agreements to the Effective state on the designated effective date. When a PV Agreement enters the Effective state, Vault additionally moves all of its associated Approved-state documents to the Effective state.

User License Warnings for SafetyDocs DocumentsAuto-on26R1.2

Maintaining strict adherence to Veeva licensing agreements is essential for organizational compliance and audit readiness. With this release, Veeva SafetyDocs identifies user license violations for Safety application users who might inadvertently access SafetyDocs features or documents without the appropriate specialized license, ensuring that access to sensitive regulatory content is aligned with user entitlements and providing immediate feedback when a license violation occurs. 

Prevent Automatic PSMF Logbook GenerationConfiguration26R1.2

Managing PSMF revisions often involves minor changes. Previously, Vault automatically generated a PSMF Logbook Entry any time a new document was created, forcing users into a rigid workflow where even minor technical adjustments such as fixing a broken hyperlink or addressing drafts created in error required a formal entry. Secondary authors often struggled to update the auto-generated PSMF Logbook Entries with their own details, leading to data gaps or blank records in the document history.

With this release, Veeva SafetyDocs allows you to prevent the automatic creation of PSMF Logbook Entries when a PSMF document is created or up-versioned, providing greater flexibility to manage minor updates and accidental draft creations without cluttering the audit trail.

QualityOne

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

RegulatoryOne

Registration & Dossier Management

Registration Objective LimitAuto-on26R1.2

With this feature, the limit of Registration Objectives for a given Registration increases from 100 to 1,000.

Veeva Claims

Veeva Claims

Clone Project: Sections OrderingAuto-on26R1.2

This feature updates the display order of records listed in related object sections displayed in the dialog after running the Clone Project action from alphabetical order to the logical order configured on the Project object layout.