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

Lab5 - Webdesign Schweiz 

www.matrix-ssi.com

Since 1993, Matrix has been implementing highly controlled printing and serialization solutions in a wide variety of packaging line environments. Our 21CFR Part 11 compliant systems ensure a secure, auditable, and accountable packaging line backed by track-and-trace to the individual unit level. Matrix has worked with companies ranging in size from single-factory operations to Fortune 500 corporations and can accommodate the unique needs of any business.

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.