Computerized system validation (CSV)
New guidelines for computerized system validation (CSV) came into force on April 1, 2012.
In installing computerized systems as part of our construction of pharmaceutical and other plants, we take an approach that conforms to these guidelines.
Our approach to CSV is broadly comprised of Management, Development and Operation.
At Toray Engineering, we have several CSV management regulations based on GAMP 5. More than just support for individual issues, such as compliance with the various guidelines of pharmaceutical manufacturing users, system categorization and assessment, effective use of suppliers and retrospective CSV, we are able to provide comprehensive services such as support for overall planning.
- CONTACT US
Tokyo office: +81-3-3241-1973
Shiga office: +81-77-533-7351