Eu Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency Gmp
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商品簡介
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.
作者簡介
Orlando Lopez is the SME for the GAMP Data Integrity SIG. He has 25 years of experience in worldwide pharmaceutical experience with relevant work in computer systems regulatory requirements including US, EU, Australian, Japanese, WHO, PIC/S, and ICH regulations and guidance. His special interest is the GMP compliance issues applicable to computer systems.
He has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation-related verifications. He is the author of two other books:21 CFR Part 11—A Complete Guide to International Compliance, Taylor & Francis/CRC Press, 2004, andComputer Infrastructure Qualification for FDA Regulated Industries, Davis Healthcare International Publishing, 2006.
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