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

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Leland Hirschman is a graphic designer, web developer, artist, musician, entertainer, and so much more! His motto, "Creativity for Hire," tells you instantly that his services know no limits! If you need a creative solution to nearly any problem you have, Leland will surely have the answer.  He is responsible for this website's development, as well as all of our design and development needs.

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.