Qualification & Validation

We have a wide range of expertise within the Pharmaceutical and Medical Device industry and clients will therefore be met by experienced validation consultants.

We are experienced within both the traditional V-model and the risk-based approach, which are normally used for the Qualification and Validation projects.

We can help you with

  • Change Control
  • Risk-analysis – FMEA, FMECA, HACCP, HAZOP, FTA, and PHA
  • Requirements-analysis (URS)
  • Validation Plannning
  • Design, Design-documentation, design review, and design qualification (DQ)
  • Commissioning (FAT/SAT)
  • Qualification (IQ/OQ/PQ)
  • Validation
    • Process validation (PV)
    • Sterilization validation
    • Cleaning validation (CV)

The risk-based approach:

The traditional V-model:

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