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

Lab5 - Webdesign Schweiz

This 21 CRF Part 11 compliant product captures handwriting on paper documents, including secure signatures, and provides searchable PDFs, clean data and secure images. Ideal for document approval, clinical trials, and form-based data capture. This is the fastest way to electronically publish an approved paper documents, and is compatible with all document/clinical management systems.  It is easily deployed, with minimal training, and users like it.

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.