Contact

Headquarters Speyer
An der Hofweide 7
D-67346 Speyer

Phone: +49 6232 91906-0
Fax: +49 6232 91906-100
Email: info.sp@spiratec-ag.com

Validation of Process Control Systems GAMP 5

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