You have to be able to do it! In order to obtain the best- possible efficiency and clarity, we have to go meticulously into detail while qualifying facility and computer, because not only the concepts are different for every facility respectively application, but also every customer has its own requirements for qualification and validation. We have a basic pattern to which we refer to, but above all we have the competence to relieve you from all your concerns on this topic.
What we do:
- Preparation of qualification plans according to GAMP5
- Preparation of quality and project plans
- Preparation of operation and hardware specifications
- Preparation of test plans and test documentation
- Implementation of supplier audits
- Implementation of functional failure analysis according to FMEA, with risk-based definition of the test scope.
- Implementation of assessments according to 21CFR Part 11
- Coordination of test phases in the project
- Coordination of Change Management (ITSM) in the project