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Pharmaceutical /
Life Science

GMP Vector Manufacturing Plant for Tissue Engineering, Courtesy of I’ROM Group Co., Ltd./ID Pharma Co., Ltd.

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

Capabilities

  • 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.

Applicable range

  • All projects with introducing computer and computerized system.

Key projects

virus vector plant

  • Irom group, ID pharma corporation virus vector plant. (Specific cell processed product manufacturing facility)
    *Right Picture
  • Confidential Vaccine plant
  • Confidential Sterile preparation plant
  • Confidential Bulk plant   
    Many others