Japan GMP Guideline on Management 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 2010 Japanese Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs.

This document includes the Japanese expectations for system documentation, development, testing, validation, qualification, SOPs, training, maintenance, security, back-up and restoration, deviation management, and retirement.