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

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