Articles by David Nettleton on the subject of Software Validation, Training, Computer System Validation, 21 CFR Part 11, FDA Compliance, and more.

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

Here, you will find regularly published articles by Computer System Validation founder, noted Author, and Compliance Expert David Nettleton.

Title
Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask
What is FDA 21 CFR Part 11?
Software as a Service (SaaS): Is Outsourcing IT a Good Idea?
FDA Regulation of Tobacco Industry
Steve Cates Joins the CSV Team
Document Record Keeping Systems - new course
Computer System Validation-Increase Productivity and Reduce Costs

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 - Ten easy Steps

Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

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.