In order to meet the stringent legal requirements, we propose the implementation of the AuditTrail system with the Logon module by Siemens.
The system allows:
creation of one central (server-based, also redundant) user base with skill matrices and access levels,
integration with RFID readers (e.g. company access card) and automatic assignment of user rights,
full control and registration of changes in production parameters introduced by the operator,
integration with MES, ERP systems,
automatic logging of machine operating states and alarms during the process.
Meet special quality requirements consistent with the European Good Manufacturing Practice (GMP) standard and U.S. Food and Drug Administration (FDA) requirements for validation requirements as described in 21 CFR Part 11,
the entries in the database are unambiguously traceable in accordance with the traceability requirements,
data stored in the form of CSV file can be equipped with security mechanisms controlling unauthorized change of contents.
Check out solutions for the pharmaceutical industry in our flyer.