On-Demand Webinar
In this on-demand session, USDM certified Veeva experts share best practices in Veeva implementation and validation drawn from more than 200 delivered projects. You will learn how to maintain your Veeva system's validated state with USDM's Cloud AssuranceTM subscription service and proven best practices to manage change control, and how to modernize your Veeva computer system validation (CSV) approach by adopting the FDA's computer software assurance (CSA) methodology.
What You'll Learn
- Veeva GxP implementation best practices grounded in more than 200 delivered projects
- How to maintain Veeva and its validated state while managing change control
- What the FDA's computer software assurance (CSA) guidance means for your Veeva systems
- How a CSA approach can improve quality while reducing the documentation burden on your IT team
- How USDM Cloud Assurance keeps Veeva continuously validated as the platform evolves
Maintaining a Validated State on Veeva
Veeva delivers frequent releases, and every change to a GxP system carries the risk of disrupting its validated state. The challenge for life sciences teams is keeping pace with the platform without letting validation and change control become a constant manual burden. This session walks through how to implement Veeva for GxP use, manage change control as the system evolves, and sustain compliance over time rather than re-validating from scratch with each release.
Modernizing CSV with the FDA's CSA Approach
The FDA's computer software assurance (CSA) methodology shifts the emphasis from exhaustive documentation toward critical thinking and risk-based testing. The webinar covers what the FDA's CSA guidance means for Veeva systems and how a CSA approach can improve quality while reducing the documentation load on your IT and quality teams. Pairing CSA with a risk-based view of 21 CFR Part 11 compliance helps focus validation effort where patient safety and product quality are most at stake.
USDM's point of view: Validation should not slow down the value you get from Veeva. With Cloud Assurance and a risk-based CSA methodology, you can keep Veeva GxP systems audit-ready and continuously validated while shifting effort away from low-value documentation and toward the testing that actually protects patients and product quality. Strong data integrity practices underpin every one of those decisions.
About the Presenters
Roger Davy, Director of Customer Engagement
Hovsep Kirikian, Project Manager, USDM Life Sciences
Donald E. Zinn, Director of Emerging Compliance
To learn more about USDM's Veeva capabilities, read our blog Five Tips for Successful Veeva Implementation.
Frequently Asked Questions
How do you keep a Veeva system in a validated state as Veeva releases updates?
By combining proven change control practices with a subscription service like USDM Cloud Assurance, teams can assess each Veeva change for risk and validate continuously rather than re-validating the entire system with every release. This keeps the system audit-ready while the platform evolves.
What is computer software assurance (CSA), and how does it differ from traditional CSV?
CSA is the FDA's methodology that emphasizes critical thinking and risk-based testing over exhaustive documentation. Compared with traditional computer system validation (CSV), a CSA approach can improve quality while reducing the documentation burden on your IT team by focusing effort on the functions that matter most.
Does adopting CSA mean less compliance rigor?
No. CSA concentrates validation effort where risk to patient safety and product quality is highest, so rigor is applied where it counts. It is designed to maintain compliance with requirements such as 21 CFR Part 11 while reducing low-value documentation.
What is USDM Cloud Assurance?
Cloud Assurance is USDM's subscription service for keeping cloud GxP systems, including Veeva, in a continuously validated state. It pairs change control and risk-based validation with USDM's Veeva expertise so your systems stay compliant as the software changes.
How can I watch this webinar?
This is a recorded, on-demand session. Watch it any time to hear USDM's Veeva experts walk through implementation best practices, maintaining the validated state, and the FDA's CSA approach.
Watch on demand: See how USDM certified Veeva experts minimize risk and maintain compliance on Veeva with Cloud Assurance and a modern CSA approach. Contact us to discuss validating and maintaining your Veeva GxP systems.