PMDA (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.