Process Validation PDF

Increase your corporate success by means of secure processes

EXCO is an established partner for the GMP-compliant validation of your manufacturing and supplier processes, thus ensuring that you obtain comprehensible and consistent documentation for all subprocesses in the supply chain.

We will take on the following tasks:

  • Project coordination
  • Creation of master validation plan
  • Process documentation
  • FMEA moderation
    - Total FMEA process
    - Assembly subprocess
    - Assembly space subprocesses (assembly, packaging technology)
    - Test stations subprocesses
    - Other subprocesses if necessary, e.g. sterile processes (application systems, filling systems)
  • Product history check (FTTR, customer complaints, CAPAs, etc.)
  • Master validation report

You benefit from a wide range of highly qualified and experienced employees who will provide you with comprehensive support right from the development of qualification strategies to project management and the creation of phase-related documentation. Our own GAMP 5-based qualification method or your methods and templates can be used for this.

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