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

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David and Janet have written a fourth book together. Managing the Documentation Maze deals with a topic of critical importance for compliance with record-keeping regulations in pharmaceutical and medical device industries. It presents more than 750 questions and answers about documentation management, whether electronic or paper-based. It defines, through a Q&A approach, what document management actually is, and why it should be a core discipline in the industry.

This book address electronic system selection and validation, system security, user accountability, and audit trails, as well as standard operating procedures for supporting document systems. It also covers electronic systems, hybrid systems, and the entire scope of documentation that companies must manage. You will learn how to write and edit documents that meet regulatory compliance. You will be able to make the transition to an electronic system and understand how to validate and document the process.

Anyone responsible for managing documents in the health field will find this book to be a trusted partner, one that demystifies the meaning of binding regulations. This book will help you put an effective, lasting system in place—one that will stand up to any type of scrutiny. (Janet Gough & David Nettleton; 2010; www.wiley.com)

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.