Validating Automated Manufacturing and Laboratory Applications: Putting Principles Into Practice 1st Edition

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Since 1994, the German GMA-NAMUR, German APV, ISPE-Baseline, OECD, UK GAMP Forum, UK IQA-PQG, US DIA, ISPE, and PDA initiatives have supplemented the regulations governing the validation of automated systems with high-level guidelines. The result has been a broadly accepted industry framework for validating automation systems. This book deals directly with project problems and their resolutions based upon the experience of established industry practitioners. It introduces the principles of good practice and why validation is needed, presents a comprehensive selection of case studies provided by industry experts, and concludes with the Ten Commandments for Validating Automation.