This short video explains in simple terminology
what Computer System Validation is
and how it saves your company money

 

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Random Testimonial

I can tell David has a lot of experience with computer system validation because David bridged the gap between IT, QA, and Clinical.

– Contract Research Organization
Los Angeles, CA

Meet our Founder

David Nettleton
David Nettleton
FDA Compliance Specialist, Author

Janet Gough
www.GxPDocumentation.com
Janet has extensive experience as a consultant to the pharmaceutical, medical device, and biotech industries. She assists companies in designing compliant systems and provides documentation and training. She also co-authored the three books listed on the 'Books' page of this website.
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One of the nation's foremost experts on CSV for 21CFR Part 11, David Nettleton and Janet Gough have written four books:

Risk Based Software Validation
Risk Based Software Validation - Ten easy Steps

Electronic Record Keeping
Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

Managing the Documentation Maze
Managing the Documentation Maze

Commercial Off the Shelf COTS Software Validation
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance

See the Books page for more information and to order.