Let USDM manage the update and compliance responsibilities so you can stay focused on other priorities.
The Veeva 22R1 release is coming 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
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.
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.
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.
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 tailored-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 will host webinars to deep-dive into the updates. You can 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
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