Asia Pacific | Healthcare and life sciences
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
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.