Chiyoda's Approach to CSV (Computer System Validation)
Computer system validation and computerized system validation are to be executed for global level because Japan has been joined PIC/S.
Computer generated data should implement Data integrity (DI) that US and Europe regulatory bodies are focusing DI during their inspection.
Chiyoda can provide global level CSV by joining PDA/ISPE and cooperating JACOBS and introduce a new computer systems that secure DI.
Example CSV Work flow
- CSV Target systems list up by System impact assessment and Risk assessment.
- Decide CSV approach by system scale and its data importance.
- Provide Integrated approach for validation and CSV.
- Support introducing a new system with DI securing.
- All projects with introducing computer and computerized system.
- Irom group, ID pharma corporation virus vector plant. (Specific cell processed product manufacturing facility)
- Confidential Vaccine plant
- Confidential Sterile preparation plant
- Confidential Bulk plant