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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
Get in touch

We accompany you on the path to digitization by providing customized and goal-oriented consulting on the use of solutions based on state-of-the-art technologies.

Christian Reinthaler

Industrial Automation Solutions