Questions and Answers of the Japanese Regulatory Authorities regarding Computerized Systems

The Japanese requirements on computerized systems are laid down in the "Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-Drugs". Now, there exists a tentative legislation into English (see the News from 19 September 2012). On the part of the authorities, answers were given to 46 questions in order to explain how this Guideline has to be understood and interpreted in the concrete case. Some of the answers are very comprehensive and detailed.

Theses questions and answers are not only interesting for companies being subject to the Japanese regulations but they also address a lot of general problems concerning computerized systems. Reference is made in part to the GAMP but also to the PIC/s document PI 011 "Good Practices for Computerized Systems in Regulated "GXP" Environments.

Please also see the

Autor:
Dr. Andreas Mangel
CONCEPT HEIDELBERG

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