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Audits

Audit Records Dashboard​

The Audit Records module provides a comprehensive, immutable log of all activities within the system, ensuring compliance with regulatory requirements (e.g., 21 CFR Part 11).

Audit Records Dashboard

Analyzing the Audit Log​

The interface is designed for quick retrieval and review of specific actions.

1. Filtering by Module​

Use the top navigation tabs to narrow down records by specific subsystems:

  • All: View a consolidated list of all activities.
  • PSUR, FMEA, Trace Matrix, Hazard, Vigilance: Select a specific tab to view records relevant only to that module.
  • Date Range: Use the period selector (e.g., "Last 7 Days") to isolate activities within a specific timeframe.
  • User Filter: Select a specific user from the "User" dropdown to audit individual contributions or changes.

3. Reviewing Records​

The data table provides detailed metadata for each event:

  • Document Type: The category of the affected file (e.g., CRA, FMEA, TRACEMATRIX-ITEM).
  • Document: The specific file name or ID being modified.
  • Action: The type of operation performed (e.g., MODIFIED, CREATED, DELETED).
  • User: The individual who performed the action.
  • Timestamp: Exact date and time of the event.
  • Actions: Click the View (Eye Icon) button to see a detailed diff of the changes.