Audit Trail

The audit trail provides a tamper-evident, chronological record of every significant action performed in the system. It captures who did what, when, and to which resource — meeting regulatory requirements for 21 CFR Part 11, EU GMP Annex 11, and other compliance frameworks.

Open the Audit Trail

1. On the left sidebar, select Admin.
2. In the admin sidebar under Compliance, select Audit Trail.

Note

The audit trail is available to users with the audit.view_trails or audit.view permission, as well as users with the Admin or QA Team role.

Filter audit logs

Use the filter panel at the top of the page to narrow down results. All filters can be combined and are applied automatically as you change them.

Filter	Description
Search	Free-text search across audit entries
User	Filter by a specific user (searchable user selector)
Resource Type	Filter by type: Document, Deviation, Training Record, Audit Log, CAPA, or User
Action	Filter by action: Create, Update, Delete, View, List, or Approve
Date From	Start date for the time range
Date To	End date for the time range
Limit	Number of entries to display: 50, 100, 200, or 500

Read the audit log table

Each audit log entry displays the following columns:

Column	Description
Timestamp	Date and time the action occurred
User	Email address or user ID of the person who performed the action
Action	The type of action (create, update, delete, view, list, approve)
Resource Type	The type of resource affected
Resource ID	The identifier of the specific resource
Details	Additional context or reason for the action
Verified	Integrity verification status (checkmark or cross)

Sort the table

1. Select any column header to sort by that column.
2. Select the same column header again to toggle between ascending and descending order.

An arrow indicator shows the current sort direction.

Verify entry integrity

Each audit log entry includes an integrity verification flag. A checkmark means the entry has passed integrity checks. A cross indicates it has not been verified or verification failed.

Caution

If you see entries with failed integrity verification, report this to your system administrator immediately. This could indicate unauthorized modification of audit records.

Export audit logs

Export to CSV

1. Above the log table, select Export to CSV.
2. Wait for the progress bar to complete.
3. The file downloads with columns: ID, User, Action, Resource Type, Resource ID, Reason, Location, Created At, Integrity Verified.

Maximum 200 records per CSV export.

Export to PDF

1. Above the log table, select Export to PDF.
2. The server generates a formatted PDF report using the current filter criteria.
3. The file downloads as audit_report.pdf.

Export to Excel

1. Above the log table, select Export to Excel.
2. The server generates an Excel spreadsheet using the current filter criteria.
3. The file downloads as audit_logs.xlsx.

Tip

For compliance audits, export as PDF for a formal report, or use Excel for further analysis and cross-referencing.

Review audit summary widgets

Above the log table, summary widgets provide at-a-glance metrics about audit activity, aggregating key statistics to help you quickly assess overall system activity.

Resolve audit findings

If there are open audit findings, an alert banner appears at the top of the page indicating how many findings require attention.

1. Scroll to the Audit Findings Resolution section at the bottom of the page.
2. Review all open findings.
3. Update finding statuses (for example, mark as resolved).

View an embedded audit trail on a resource page

Individual resource pages (such as document detail views) include an embedded audit trail showing only the history for that specific resource. This embedded view displays the timestamp, user, action, and additional metadata for each entry.

Practical example: Prepare audit trail evidence for an FDA inspection

An FDA inspector requests a complete record of all changes made to SOP-042 “Aseptic Processing” over the past 12 months, including who made each change and who approved it.

1. Open the Audit Trail from Admin > Compliance.
2. Set the filters:
   • Resource Type: Document
   • Search: “SOP-042”
   • Date From: one year ago
   • Date To: today
   • Limit: 500
3. Review the filtered results. Each entry shows the timestamp, user, action (create, update, approve), and details of the change.
4. Verify that all entries show a checkmark in the Verified column, confirming tamper-evident integrity.
5. Select Export to PDF to generate a formal report.
6. Hand the audit_report.pdf to the inspector.

The exported report provides a complete, tamper-evident chain of custody for the document — showing every draft, review, approval, and revision with timestamps and user identities. This satisfies 21 CFR Part 11 requirements for electronic records without any manual log compilation.

Permissions

Role / Permission	Access Level
Admin	Full audit trail access
QA Team	Full audit trail access
audit.view_trails	View audit logs
audit.view	View audit logs