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

Lab5 - Webdesign Schweiz 

I took your "Complying with Computer and Software Validation Requirements" through PTi in February (San Diego). This is just an unsolicited positive review of that course -- I've since had a couple of other training courses (completely different topics, completely different companies), and I just wanted to let you know that your course was probably the best training I've had in years. I've told anyone who asked that I'd recommend your course to others, no question.

– PTI Student
San Diego

David's Books

One of the nation's foremost experts on CSV for 21 CFR Part 11, David Nettleton has written four books with Janet Gough:

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.