EU Annex 11 Guide to Computer Validation Compliance – Orlando Lopez, Markus Roemer

Recommended reading in 2015:

This book provides practical information to enable compliance with computer system validation requirements, while highlighting and integrating the Annex 11 guidelines into the computer validation program. The ideas presented in the book are based the author’s experience in the US Department of Defense and regulated industries in various computer systems development, maintenance, and quality functions. A practical approach is presented to increase efficiency and to ensure that software development and maintenance is achieved correctly.

March 27, 2015 Forthcoming by CRC Press
Professional – 368 Pages – 22 B/W Illustrations
ISBN 9781482243628 – CAT# K23442

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