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

Lab5 - Webdesign Schweiz

QST Consultations, Ltd., founded in 1974, is an independent statistical consulting firm that specializes in clinical study and case report form design, data management, biostatistical analysis, medical writing, and complete management of eCTD submissions. The company’s involvement includes many successful phase 1-3 and post-marketing clinical studies designed to support 510(k), PMA, ANDA, and NDA submissions, along with ongoing marketing activities. QST currently works with a range of clients that extend from small start-up organizations to well-established leaders in the pharmaceutical and medical device industries.

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.