Japan Q&A on GMP Guideline on Managment of Computerized Systems, 10/10

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In August 2011, an independent Computer System Validation study group produced this English translation of the Q&A document that accompanies the 2010 JapaneseﾠGuideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drags and Quasi-drugs.

This document provided clarification of which systems are within scope of the Japanese guideline as well as insight into expectations for validation approaches, business continuity, system inventory, system categorization, and system retirement.