Validation

All computer-based systems used in the service environment are subject to a validation test. Depending on the criticality assessment, the system is validated. The validation is implemented according to Gamp5 and follows the risk-based approach. In the service context of archiving, the archive management system is classified as relevant to validation and is validated. Validation completion occurs after full testing of all previously expected functions. The valid status is maintained via an integrated change management system and continuous functional tests. Periodic checks permanently confirm the validation.