Chiyoda's Approach to CSV (Computer System Validation)

When a new system is introduced, Chiyoda performs prospective CSV according from scale of the system and the impact to final product.
For systems with which proper CSV has not been performed, Chiyoda performs CSV with its unique retrospective approach.


Documents submitted (examples)	Business assessment report	CSV review planning Risk assessment-related documents Supplier audit-related documents CSV action list CSV review protocol CSV review report	New system concept formulation documents User Requirements Specification (URS) Functional specification Design specification FAT-related documents SAT-related documents	CSV plan Risk assessment-related documents Supplier audit-related documents Traceability matrix IQ protocol/report OQ protocol/report CSV summary report
Periods (for reference)	One month	About 3 to 6 months	About 10 to 24 months	About 3 to 6 months

The service period varies slightly depending on the scale and complexity of the system.