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)