Validation of Process Control Systems GAMP
Requirements of the regulated industry
As a vendor for the regulated industry, we ensure that our clients can meet all legal requirements during all the phases of a project . We then implement the resulting requirements in close cooperation with our clients.
- Functional specifications
- Risk analysis / risk assessment
- Adjustment with VMP/MVP
- Implementing SOP, implementation guidelines
- Training matrix
- Design specifications
- Test specifications
- Tests, test reports
- Traceability matrix
- FAT, SIT, SAT plans and reports
- Documentation version control /-management etc.
- Support in the process-IQ, -OQ, and -PQ together with process engineering