In many regulations and laws, especially in the manufacture of pharmaceutical products, the validation of processes is required wherever processes are supposed to provide a reproducible product according to previously specified requirements. Methods are standardised and validated in order to ensure that a method reliably produces the expected result within defined limits (specifications). Corresponding proofs must be documented. Validation includes systematic checking of installations, equipment and processes to ensure that they are suitable for the intended purpose.
Sympatec provides a comprehensive documention for validation as an add-on to support the qualification of the installations in a validated (mainly pharmaceutical) environment. Therefore, a Validation Binder contains all documents created during production, system integration and on-site installation.
Installation Qualification (IQ)
- Check of general operating conditions, including supplies and environment
- Verification of the proper installation of all delivered components, identified by their serial numbers
- Software validation by a check list of all installed files and Windows® registry entries
Operational Qualification (OQ)
- Check of the manual and remote controlled functionality, communication and data evaluation
- Verification of the proper function of all delivered components
- Copies of the documents generated during the production of the system components
Production Operational Qualification
- Copies of the performed circuit board and functional tests of the components after assembly