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)