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.

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

We can help you with

• Project management
• Design (CD/BD/DD), 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)