New in Veeva Basics 25R2

Release date: August 1, 2025.

Veeva Clinical Basics

Major Features

The Veeva Clinical Basics team is excited to share the following major features in the 25R2 release:

  • Study Personnel Expiration: Access for Study Personnel now automatically expires when their assigned End Date is reached.
  • New Role for TMF Managers: A new TMF Manager role has been introduced, giving TMF Managers a study-specific role to manage access and correct approved documents within their assigned studies, improving control and accuracy.
  • Tracking Organizations: Users can now track the Organization a document is associated with for all documents under Third Party.

Minor Enhancements

Additionally, there are other minor enhancements across the application. Refer to the lists below for each app. More information will be available in the Release Summary.

General

  • The user page layout has been updated for harmonization across Vault applications.
  • The “Reports” tab name has been updated to “Reports and Dashboards”.
  • The Vault Admin role has been updated to focus on technical and user setup tasks.

CTMS

  • The DMR Complete and DMR Complete Date fields have been replaced by new SDR Requiredness and SDR Complete? fields on the Subject Visit object.
  • Study Managers and Monitors can now edit Completed milestones.

eTMF

  • The Source Document Number field is now visible to users for documents received via TMF Transfer.
  • The QC Workflow now restricts the workflow initiator from self-assigning the QC task.
  • Study Managers and Monitors can now see all Quality Issues related to the studies to which they have access.

Veeva Quality Basics

Major Features

The Veeva Quality Basics team is excited to share the following major features in the 25R2 release:

General

  • New Quality Admin Role: The Vault Admin role has been updated to focus on technical and user setup tasks, and a new Quality Admin role has been added to manage reference data and perform other administrative tasks.

QualityDocs

  • Non-GxP Training Materials: Non-GxP Training Materials can now be created and approved without the need for a DCC or of a QA person.
  • LearnGxP Security Profiles: New security profiles have been added to allow non-GxP users to complete corporate training within the system without giving them access to view GxP materials.
  • Binder Creation: The ability for admins to create Binders has been added.
  • Confidential Documents: A new Confidential? field has been added to documents.
    • Note: Refer to the Release Summary for more info on how this field impacts document visibility.
  • Periodic Review Assignee: Periodic Review tasks are now assigned to the Document Owner rather than Document Control.
  • Automated Collaborative Authoring Check-Out Workflow: The Collaborative Authoring workflow has been streamlined with automatic check-in and check-out of the document for Collaborative Authoring.

Training

  • Automatic Learner Role Assignment: Users can now automatically be assigned to Learner Roles based on Department or Job Title.
  • Training Requirement Prerequisites: Prerequisites can now be created to require learners to complete training assignments in a specific order within a curriculum.

QMS

  • Simplified External Deviation: External Deviations now close after the Assessment stage regardless of rating, and do not require investigation.

Minor Enhancements

Additionally, there are other minor enhancements across the application. Refer to the lists below for each app. More information will be available in the Release Summary.

General

  • Vault Admins can now assign users as delegates, allowing them to login and complete activities on another user’s behalf.
  • Department and Job Title fields have been added to the User and Learner pages.
  • The User page layout has been updated for harmonization across Vault applications.
  • Several enhancements have been made to reports and dashboards:
    • Added a “Training Assignments with Job Title” report.
    • Added a “Learner Curriculum Completion” report.
    • Added an “Overdue Training Assignments by Manager” report.
    • Added reports for supporting documents.
    • Added informational QMS reports for key records with optional filters.
    • Added reports for upcoming unplanned audits.
    • Added reports for audits approaching and awaiting workflow start.
    • Added date and product filters to the “Training Assignments with Documents” report.
    • Excluded Obsolete documents from the “Documents with Periodic Review. Starting in the Next 90 Days” report.
    • Excluded LearnGxP content from document reports.
    • Enhanced columns in several reports.
    • Added upcoming unplanned audits to the audit dashboard.
    • Added audits approaching and awaiting workflow start to the audit dashboard.
    • Added closed on time pie charts to QMS dashboards.

QualityDocs

  • A Batch field has been added to relevant documents.
  • Owning Facility,Owning Department, Product, and Document Supplier fields have been added as optional to relevant QMS Documents.
  • The Authoring workflow has been renamed to Authoring/Review to more appropriately reflect its purpose.
  • Authors are now removed from a document after the workflow owner’s review task, rather than after their own task.
  • Product Abbreviation and Department Code are now searchable fields.

Training

  • LearnGxP training now displays a thumbnail image in the My Learning page.
  • Facilitated Training records can now be cancelled.
  • Training completion due dates now reflect the user’s timezone rather than the Vault’s.

QMS

  • Added a new tool, QMS Team Management, that allows Vault and Quality Admins to bulk update the Team section on QMS records.
  • Audit Details fields can now be edited during the In Audit Reporting stage.
  • When navigating from a Finding, QA Approvers of CAPA Actions and Effectiveness Checks now default to those of the Finding.

Veeva RIM Basics

Major Features

The Veeva RIM Basics team is excited to share the following major features in the 25R2 release:

General

  • Application Chronology Report: This report has been added to track Application, Submissions, Commitments, Regulatory Objectives, and Correspondences in chronological order.
  • Report for Content Plan Owners: This report has been added to show content plan sections/items for which they are the assigned owner.
  • Collaborative Authoring Permissions: The ability to cancel editing and save to Vault within a Collaborative Authoring session has been limited to the Document Owner and the user that initiated the session.
  • Collaborative Authoring Workflow: The Collaborative Authoring workflow has been streamlined with automatic check-in and check-out of the document.

Submissions

  • Commitment Extraction: Users can now extract and create commitments from text within Correspondence documents.

Submissions Archive

  • Sequence ID Requirements: The Sequence ID field is now required on non-eCTD Submissions in order to ensure data completeness.

Minor Enhancements

Additionally, there are other minor enhancements across the application. More information will be available in the Release Summary.

General

  • Applications, Submissions, Regulatory Objectives, and Health Authority Questions are now available as Commitment Relationships.
  • Commitments and Health Authority Questions are now available as Regulatory Objective Relationships.
  • The ability to remove documents from a Multi-Document Workflow has been limited to the Vault Admin and the owner of that MDW.
  • Enhancements have been made to existing reports:
    • Added a Planned Submission Date column to the Submission Calendar report.
    • Added an Actual Submission Date column to the Submitted Submissions by Type and Archived Submissions in the Last 7 Days reports.
  • The Method of Communication field picklist has been updated with new values.
  • New Document Types have been added:
    • Quality > Regulatory Support > Investigational Medicinal Product Dossier (IMPD) Summary of Changes
    • Quality > Regulatory Support > Investigational Medicinal Product Dossier (IMPD) Tracked Changes
    • Quality > Regulatory Support > Pharmacy Manual
  • A new RIM Admin role has been added and is responsible for creating and managing core data, such as product families, products, etc.
  • Vault Admins now have Technical Setup and Loader permissions.
  • The user page layout has been updated for harmonization across Vault applications.
  • Vault Admins can now select a preferred landing tab on a per-user basis.
  • Logging available to Vault Admins has been cleaned up to surface the most relevant logs.
  • Vault Admins can now export all available system logs.
  • Vault Admins and RIM Admins, as well as Binder Owners, can now change the owner and sharing settings of a binder.
  • Vault Admins and RIM Admins can now version and delete documents in the superseded state of the general lifecycle.
  • The Primary Product Family field has been added to the Investigational and Marketing Submission page layouts.
  • The Username field has been added to default lists and hovercards for the User object.
  • Additional classifications have been added to support Health Authority Question and Commitment extraction.