We offer expertise within qualification and validation to the pharmaceutical industry. We have extensive experience with project management and, consequently, are prepared to undertake validation projects as well as procurement and qualification of e.g. new laboratory equipment, larger indoor environment facilities, autoclaves or similar.
Our expertise covers all phases of the project, from design to putting into operation. We have experts within both automation and validation, and we can therefore enhance the validation process by working cross-functionally.
Confirm has wide experience with drawing up documentation as well as with practical execution of validation- and qualification tests according to requirements prevalent in Denmark as well as those of other European countries and America.
We can help you with:
- Project execution
- Design, design documentation and design review
- Risk analysis – FMECA, HACCP and FMEA
- Validation plans
- Change cases
- Requirement specifications (URS)
- Commissioning (FAT/SAT)
- Qualification (IQ/OQ/PQ)