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An Introduction to Computer System Validation

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.

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.

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.

This webinar 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. To discover how using automation can significantly enhance quality and safety, watch An Introduction to Computer Software Assurance.

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?


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.

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

On-Demand Webinar

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