The Bergami customer care qualification services are based upon approved SOPs (Standard Operation Procedures) that are up-to-date and comply with GMP guidelines. They contain the individual procedural levels. Results are discussed with customers. A deviation procedure is carried out if there are serious differences.
All documentation is subjected to a version check and an amendment check. At the beginning, the Quality Plan (QP) is produced in close consultation with the customer, it determines the tests and the test schedule to be completed for qualification.
- DQ: Design qualification
- IQ: Installation qualification
- OQ: Operational qualification
- PQ: Performance qualification
- FS: Functional Specification
- HDS: Hardware Design Specifications
- SDS: Software Design Specifications
- DQ: Design qualification
- IQ: Installation qualification
- OQ: Operational qualification
- PQ: Performance qualification
- Change Control Specification
- Traceability Matrix
All validation and qualification operations, results and alterations are summarised in the final document, the Quality Report (QR). Additionally, it contains references to all test reports and raw data.
The prospective Computer System Validation (CSV) encompasses the specification, production, testing and validation of software and we complete it in accordance with the GAMP guideline (Good Automation Manufacturing Practice). The “21 CFR Part 11” law of the American health authorities is taken into full consideration.