Metasys® for Validated Environments (MVE ... - Johnson Controls

Figure 7 shows the standard M-Alarm Reportinterface. From master M-Alarm Report, alarms andevents can be listed and filtered for review. Thissame logger can be used to view the audit trail ofalarms and operator transactions. It gives theoperator a window into all automatic and manualcontrol actions that have occurred in the system,collected in the secure database.All transactions contain: old and new values, date andtime of occurrence, identification of the operator, eventname, device tag name, units, and optionally an operatorannotation of the event.Figure 7: M-Alarm ReportsTime-stamped Audit TrailsThe ability to chronologically retrace alarm andevent transactions is paramount to reproducing anaudit trail during a facility system’s review by theFDA. This Part 11 requirement is met byimplementing the M-Alarm Logger of the MVE. Inaddition to logging alarms and the operator’sresponse to those alarms, it also logs events as theyoccur on the network.The secure system database contains all of thesealarms and events. The entries log both the time anddate of the individual operator transaction (for example,Login, Logout, Alarm Acknowledge, and Value Adjust orOverride) and also log the identity of that operator,providing an audit trail of the operation of the system.6 Metasys for Validated Environments (MVE) Product Bulletin