SIGMA Process & Automation GmbH

Process automation is our DNA

Qualification: Testing for Conformity.

The qualification and validation of regulatory computer systems are of fundamental significance, especially in the manufacture of pharmaceutical products. All results of production processes that cannot be verified by measurement or inspection must be validated.

Our experts perform the necessary tests independently and on their own responsibility, usually in cooperation with the customer’s qualification department. Activities are carried out in a multi-stage process for qualification of design, installation, function, and performance. Our staff subsequently ensure that all document and software versions defined over the entire course of the project are documented in compliance with FDA and GMP and oriented to GAMP5.

What we do for you:

  • 21 CFR Part 11 analyses
  • GMP risk analyses
  • Design, installation, function, and performance qualifications
  • Requalifications