Ingenieurbüro SIGMA GmbH

Your competent partner for automating processes.

Qualification

Qualification is of great importance and a fundamental element for the quality of pharmaceutical products.
It is also a prerequisite for further validation work.

The activities around the qualification are:

  • FDA-conform
  • GMP-conform
  • GAMP5-orientated

What we do in qualification:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Preparing and working out qualification plans
  • Risk assessment
  • 21 CFR Part 11 analysis
  • Requalification
  • Auditing
  • Change Control
  • Develop and setting up final reports