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

Lab5 - Webdesign Schweiz 

Managing the Documentation Maze is an excellent reference source in an easy-to-follow Q&A format for all healthcare professionals involved in the drug discovery process, development and manufacture of therapeutic products. Questions regarding all aspects of document management, validation, regulatory compliance, transition to electronic systems are clearly answered is an uncomplicated style by the authors, based on their extensive industry experience.

- Book Reader

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.