Summary
Veeva Vault 22R1 introduced new platform capabilities and data model changes across the Clinical, Quality, Regulatory, Commercial, and SiteVault application families. For regulated life sciences teams, every Veeva release carries a validation and compliance impact that pulls resources away from higher-priority work. USDM Cloud Assurance™ manages the release for you—assessing risk, updating test cases, processing change control, and maintaining continuous compliance—so your team stays focused on what matters.
Let USDM manage the update and compliance responsibilities so you can stay focused on other priorities
The Veeva 22R1 release came April 22. We know it can be difficult to keep up with these system changes, especially if you are forced to redirect resources from high-priority projects to manage this release. And what about maintaining compliance? Why not let USDM manage Veeva releases for you?
Veeva 22R1 has new features, including Data Model Changes:
- 22R1 Data Model Changes: Platform
- 22R1 Data Model Changes: Clinical Operations
- 22R1 Data Model Changes: Commercial
- 22R1 Data Model Changes: Quality
- 22R1 Data Model Changes: Regulatory
- 22R1 Data Model Changes: SiteVault
- 22R1 Data Model Changes: QualityOne
- 22R1 Data Model Changes: RegulatoryOne
- 22R1 Data Model Changes: Veeva Claims
Why releases matter for validated systems: In a GxP environment, a vendor release isn’t just a software update—it’s a regulated change. Data model changes can touch validated configurations, and undocumented impacts create audit risk. A disciplined computer software assurance (CSA) approach focuses testing effort where patient safety and data integrity risk is highest, so you validate what changed without re-validating everything.
To ensure that you implement this functionality quickly and seamlessly, USDM Cloud AssuranceTM manages your updates and maintains continuous compliance. What does this mean for you?
- Minimizing risk and maximizing your team’s capacity for other projects.
- Leveraging USDM’s annual vendor audit to save time and money.
- Deploying best practices for GxP configurations to deliver greater productivity and efficiency within your organization.
- Training and organizational change management (OCM) by USDM drives user adoption and maximizes your Veeva ROI.
Let USDM manage Veeva releases for you—so your team can stay focused on high-priority projects while your systems stay continuously compliant.
Annual Vendor Audit
Annually, as part of the USDM Cloud Assurance service and to replace the need for individual audits, Veeva hosts USDM as an independent, qualified third-party to audit their design, development, testing, qualification, and maintenance methodologies. The audit is specifically scoped to the Veeva Systems infrastructure and the various Veeva Vaults to ensure compliance with U.S. Food and Drug Administration (FDA) software compliance standards, including 21 CFR Part 11 electronic records and signatures requirements.
Results of the audit are compiled into the Veeva Vendor Assurance Report, which is a comprehensive reference document that provides a summary of the audit, cites all source material reviewed during the audit, and provides direct links to all publicly available content.
How USDM Cloud Assurance Manages Each Release
Rather than scrambling each time Veeva ships an update, USDM Cloud Assurance turns release management into a repeatable, audit-ready process. The framework below shows how a release moves from announcement to a continuously compliant system.
1. Release Notes Risk Assessment
USDM analyzes Veeva release notes and assesses the impact to your specific configurations and deployments, so you get a tailor-made risk assessment instead of a generic checklist.
2. Updated Test Cases
Based on the risk assessment, we draft test scripts for USDM Cloud Assurance subscribers—targeting the changes that actually affect your validated state. This risk-based approach aligns with sound validation lifecycle management practices.
3. Change Control Authoring and Processing
For Premium subscribers, USDM manages the change control process for each Veeva release, keeping documentation inspection-ready.
4. Test Case Execution
For Premium subscribers, USDM executes the required test cases according to internal policies and procedures, and industry best practices—closing the loop on the release with documented, traceable evidence.
Additional USDM Services
In addition to Cloud Assurance services, USDM offers post go-live support via best practices guidance, managed services, and validation support for enhancements, including:
- Release Notes Risk Assessment – USDM analyzes Veeva release notes and assesses the impact to your specific configurations and deployments. You get a tailor-made risk assessment.
- Updated Test Cases – Based on the risk assessment, we draft test scripts for USDM Cloud Assurance subscribers.
- Change Control Authoring and Processing – For Premium subscribers, USDM manages the change control process for each Veeva release.
- Test Case Execution – For Premium subscribers, USDM executes the required test cases according to internal policies and procedures, and industry best practices.
Important Dates and Links for Veeva 22R1
Prior to the Vault 22R1 release, Veeva hosted webinars to deep-dive into the updates. You could register for any or all sessions.
- Vault Platform (New features available in all Vaults—relevant to all audiences)
- Vault Clinical (Vault eTMF, Study Startup, Vault CTMS)
- Vault Quality (QualityDocs, Station Manager, Vault Training, and Vault QMS)
- Vault RIM (Submissions, Submissions Archive, Registrations, and Publishing)
March 15 (Last Updated): Release Impact Assessment on Vault Help
March 21: All 22R1 pre-release Vaults available
March 21-15: Validation documentation available
April 8: Release to all limited release PODs
April 22: Release to all general release PODs
FAQ: Veeva Vault 22R1 and Continuous Compliance
When did Veeva Vault 22R1 release?
Pre-release Vaults were available March 21, the release reached all limited release PODs on April 8, and general release PODs received 22R1 on April 22.
What changed in Veeva Vault 22R1?
22R1 included new platform features plus data model changes spanning the Platform, Clinical Operations, Commercial, Quality, Regulatory, SiteVault, QualityOne, RegulatoryOne, and Veeva Claims application families.
Why do Veeva releases create a compliance burden?
In a GxP environment, a vendor release is a regulated change. Data model and configuration changes can affect your validated state, and undocumented impacts create audit risk—so each release needs a risk assessment, updated test cases, change control, and documented test execution.
How does USDM Cloud Assurance help with Veeva releases?
USDM Cloud Assurance manages updates and maintains continuous compliance by performing a release notes risk assessment, drafting updated test cases, authoring and processing change control, and executing test cases for Premium subscribers—backed by USDM’s annual vendor audit of Veeva.
What is the Veeva Vendor Assurance Report?
It is the comprehensive reference document produced from USDM’s annual independent audit of Veeva. It summarizes the audit, cites all source material reviewed, and provides direct links to publicly available content, replacing the need for individual customer audits of the platform.
Let USDM Manage Your Next Veeva Release
Don’t let the next Veeva release pull your team off higher-priority work. Contact USDM to learn how Cloud Assurance can manage your updates, validation, and change control while keeping your Veeva Vault systems continuously compliant.
