Computer System Validation (CSV) for life sciences professionals new to the industry
Feedback from our Forward-Thinking GxP Compliance & Process Optimization event in January indicated that many in the industry wanted to learn the fundamentals of CSV. David Blewitt fulfills that request in this on-demand webinar.
CSV is the process of testing and validating or qualifying regulated, GxP computer systems to ensure they do exactly what they are designed to do in a consistent and reproducible manner that is safe, secure, and reliable—and generates the records to prove it.
It is required for regulated life sciences companies, and you can’t do business without following CSV regulations. The FDA requires it, as do many other global health authorities.
What you’ll learn
- The definition of Computer System Validation and the rationale and requirements behind it.
- Which IT systems and software fall under CSV expectations.
- Key implementation considerations for standing up CSV across your systems.
- What to weigh when selecting technology for a regulated environment.
- What happens when you fail to comply—and why audit-readiness matters.
Who this on-demand webinar is for
Following USDM’s Forward-Thinking GxP Compliance & Process Optimization event, some attendees asked for a follow-up webinar on CSV basics. This webinar intends to fulfill that request.
It is geared toward life sciences professionals new to the industry or pre-commercial companies selecting their IT systems and determining the most efficient way to achieve an audit-ready CSV methodology across their IT systems. Because CSV is fundamentally about trustworthy electronic records, it goes hand in hand with 21 CFR Part 11 compliance and broader data integrity expectations. To discover how using automation can significantly enhance quality and safety, watch An Introduction to Computer Software Assurance.
What this discussion of CSV includes
- The definition of CSV
- The rationale and requirements for CSV
- Applicable IT systems and software
- CSV implementation considerations
- Considerations for selecting technology
- What happens when you fail to comply?
USDM’s point of view: CSV isn’t a one-time hurdle—it’s the foundation of trust in every regulated system you run. Getting the fundamentals right early, especially for pre-commercial and growing companies, prevents costly rework and keeps you audit-ready as your technology footprint expands. The same discipline that proves a system works also positions you to adopt risk-based approaches like Computer Software Assurance (CSA) and to keep validated systems compliant over time through continuous compliance.
Presenter
David Blewitt, VP of Cloud Compliance, USDM Life Sciences. David has more than 25 years of experience in the pharma, medical device, biotech, and blood management industries, specifically in the fields of IT, CSV, and cloud compliance.
Frequently asked questions about Computer System Validation
What is Computer System Validation (CSV)?
CSV is the process of testing and validating or qualifying regulated, GxP computer systems to ensure they do exactly what they are designed to do in a consistent and reproducible manner that is safe, secure, and reliable—and that they generate the records to prove it.
Why is CSV required for life sciences companies?
It is required for regulated life sciences companies, and you can’t do business without following CSV regulations. The FDA requires it, as do many other global health authorities. Closely related expectations around electronic records and signatures are covered by 21 CFR Part 11.
Which systems and software does CSV apply to?
CSV applies to regulated, GxP IT systems and software. The webinar walks through the applicable IT systems and software, the rationale and requirements for validating them, and how to determine which of your systems are in scope.
Who should watch this webinar?
It’s geared toward life sciences professionals new to the industry and pre-commercial companies that are selecting their IT systems and looking for the most efficient way to achieve an audit-ready CSV methodology across those systems.
What happens if you fail to comply with CSV requirements?
Non-compliance carries real regulatory consequences. The webinar covers what happens when you fail to comply and why establishing an audit-ready, repeatable CSV approach protects your business.
Watch on-demand: Press play to watch An Introduction to Computer System Validation at your own pace. Have questions about building an audit-ready CSV program for your systems? Contact USDM Life Sciences to talk with our compliance team.
Additional resources
Here are links to the Forward-Thinking event session replays and companion white papers:
Session 1 video: Your Compliance and Technology Today
Companion white paper: Top 5 Opportunities to Improve Compliance Maturity
Session 2 video: Managing Your Regulated Cloud Technology
Companion white paper: Why You Should Consider Outsourcing Your Cloud Vendor Qualification
Session 3 video: FDA Perspectives on Cloud Technologies
Companion white paper: Considering CSA? Here’s what you need to know
Session 4 video: Extracting Value from Your Cloud Data and Processes
Companion white paper: Google Cloud Platform for Life Sciences and Health Technology