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

Lab5 - Webdesign Schweiz

GxP Statistics specializes in advanced biostatisticial techniques, the prediction of events and non-linear modeling. With over 30 years of experience, the consultants at GxP Statistics have participated in medical device development and approval, clinical pharmaceutical trials, FDA submissions, journal article and patent writing and expert witness testimony, both in court and before the Congress of the United States of America. GxP Statistics will integrate professional statistical analyses with your QA system.

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.