1TGMPAUDIT.10-01

• Recording of user events, value changes, OPC UA events and much more
• Store the event list with password protection and without risk of tampering
• Support when meeting FDA 21 CFR Part 11 requirements

mapp Audit collects and manages a wide range of different events. These include when user-defined events occur, when machine operators log in/out or when an alarm occurs. All events are collected and can be exported with password protection to protect them from tampering.

Applicazioni tipiche:

• Machines and manufacturing systems that must meet FDA 21 CFR part 11 requirements
• Tracking machine events
• Tracking user actions, especially in the pharmaceutical and food processing industries

Ambito funzionale:

mapp Audit defines which types of events on a machine should be recorded. These can include OPC UA events, value changes, user-defined events, alarm management events (mapp AlarmX), user management events (mapp UserX) or other mapp components. The collected events can be displayed in an HMI application and exported to a storage medium as a text or PDF file. The event list can be filtered with a filter function. The created audit trail is tamper-resistant and password-protected to ensure data integrity.