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
