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CSV Guidelines (Japan)

The Japanese Ministry of Health, Labour and Welfare formulated the "Guideline on Management of Computerized Systems for Validation for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs" standard to provide guidance for marketing authorization holders and manufacturers of drugs and quasi-drugs.

In order to help customers understand how we support compliance with these guidelines, we've created a CSV Guidelines Whitepaper as well as a CSV Guidelines Control Mapping. Many of the regulations described in the whitepaper have been certified by third-party compliance programs, such as ISO/IEC 27001, ISO/IEC 27017, and ISO/IEC 27018.

Relevant products & services

Region

Asia Pacific

Industry

Healthcare and life sciences