With IWK qualification engineers, you have a strong partner at your side.
Our qualification engineers have been supporting customers for over 20 years, providing validation documents specifically adapted to their systems.
Our various qualification packages cover your needs in an easily scalable format.
- Specifications for your system (DQ)
- GMP risk analyses
- Test protocols for IQ and OQ
- Traceability matrix
We will be very happy to adjust the scope to your individual needs in accordance with GAMP 5, or work with you to perform joint risk analyses in order to determine your needs.
We are of course also available if your system is already in operation and its validated condition needs to be maintained.
- Modification protocols in the event of minor software adjustments
- Requalification in the event of conversions or system modifications
- New qualification of older systems after conversion to new hardware/software
Our trained service engineers are available to support you in performing qualification work in all the necessary phases.