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

David provided leadership for the team, so we all knew what was expected of us. We completed the project in one-third the time.

–  Medical device manufacturer
Houston, TX

Meet our Founder

David Nettleton
David Nettleton
FDA Compliance Specialist, Author

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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
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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.