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

Lab5 - Webdesign Schweiz 

www.sagekey.com

We employ a repeatable, controlled, disciplined Quality Assurance methodology to design, build and validate software. We are a healthy company with a successful track record - fourteen years, six hundred projects, and satisfied customers in 14 countries. SageKey focuses on developing and maintaining defect free software, and providing outstanding customer service and support.

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.