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

Secure Software Certificate
www.securesoftwarecertificate.com
SSC LogoAs an independent and trusted third-party, we audit Software Vendors and Value-Added Resellers. Only those audits that receive superior results will receive a Secure Software Certificate. Certification provides assurance that the software has passed a rigorous audit that allows you to compare vendors and products against a uniform standard of quality and security. You can also be assured that your software meets the highest standards in software security, electronic signatures, regulatory compliance, and overall quality.
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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
Read a Review

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.