Validation of Process Control Systems GAMP

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