GMP COMPLIANT AUDIT TRAIL
In order to meet the strict regulatory requirements – our company INEE Industry Ltd. proposes to implement Audit Trail system compliant with GMP, GAMP5 and FDA together with Logon module from Siemens.
The system in question 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);
- automatic assignment of user right;
- 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.
We cordially invite all interested parties to contact us – as specialists in our field, we guarantee the correct implementation of the Audit Trail system, which is an excellent way to control production, especially automation for pharmaceuticals.
Benefits of implementing the Audit Trail system
Discover today the excellent benefits of introducing the Audit Trail Siemens system to your enterprise, which will help you meet special quality requirements in accordance with the European GMP (Good Manufacturing Practice) standard, as well as the US FDA (Food and Drug Administration) requirements for validation requirements described in 21 CFR Part 11.
In addition, you will gain database entries that are uniquely traceable according to traceability requirements. Another benefit of the Audit Trail system is the ability to save data as a CSV file, which can then be equipped with security mechanisms to control unauthorized alteration of the contents.