The manufacture of medical products requires validation of processes. The most important guideline to be respected is that of the USA health authority FDA decreed directive 21 CFR Part 11.
The key requirements to be respected are:
- Access control including electronic signature
- Process modification management
- Data recording and storage
Our system control combined with the options of WinCC flexible / Audit and WinCC flexible / Change Control as well as SIMATIC Logon offers everything necessary to guarantee simple qualification of machines.
In addition we propose a qualification package containing:
- Support for risk analysis and validation plans
- IQ and OQ
In this way, we cover all aspects of the machine qualification process.