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 .