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: