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
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.