Audit Trail

The Audit Trail system is designed to record events within the monitoring system, primarily related to the user interface and interactions with the system, such as user actions. This is crucial for monitoring user actions and identifying users. The following events should be logged:

1. System startup/shutdown
2. User login/logout
3. Execution of certain GxP-critical functions by users
4. Changes to system settings, including changes to alarm/warning limits, changes to measurement channel modes, scaling factor adjustments, etc.
5. Changes to system time

These features ensure accountability and traceability of user actions in compliance with GxP requirements.

Tarqvara GMP Monitoring System

The Tarqvara GMP Monitoring System incorporates a secure Audit Trail that records all significant actions and events, including system time manipulations. These logs are defined based on a risk-based approach and GMP best practices to ensure full compliance and data integrity throughout the system.

See also:
GMP Monitoring Systems
Tarqvara GMP Monitoring System
IT Solutions / GAMP / Data Integrity (RDI)
Computerized Systems Validation (CSV)