Qualification & Validation

We have a wide range of expertise within the pharmaceutical industry, and clients will

therefore be met by experienced validation consultants.

The V-model approach is normally used for the Qualification and Validation projects.

We can help you with

  • Project management
  • Design, Design-documentation, and design review
  • Risk-analysis – SIA, RRA, FMECA, HACCP and FMEA
  • Validation Plans
  • Change Requests
  • Requirements-analysis (URS)
  • Commissioning (FAT/SAT)
  • Qualification (IQ/OQ/PQ)