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

Lab5 - Webdesign Schweiz

DocXellent (formerly Mystic Management Systems) has been providing reliable trusted solutions to companies from the Fortune 500 to small businesses since 1983. DocXellent provides affordable, easy-to-use, web-based, off-the-shelf total Quality Management Solution for Document Control Systems (DCS), Packaging/Specification Management, Corrective Action & Preventative Action (CAPA), and Employee Training 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
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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.