Qualification made easy.

You receive all documentation required for qualification and validation – for machines as well as subsequently supplied components. These comply with your requirements and, of course, with FDA, 21 CFR Part 11, GMP and GAMP guidelines. The sole purpose: reliable packaging with top quality and perfect processes.

We offer:

  • Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ)
  • Function specifications
  • Traceability matrix
  • Sensor and actuator plan
  • Process flow, product flow, and block diagrams
  • Execution of qualification including completion of Uhlmann qualification documents

Your benefits:

  • Greatly reduced qualification period, thus fast (re-)startup
  • Verification of regular maintenance and checks for auditing purposes

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