Skip to main content
Activity history and operational reporting. Covered mutation events retain who, what, when, and captured change details, with attributable e-signatures on named controlled transitions.

​
Audit Log

Chronological records for covered mutation events such as document approvals, deviation updates, CAPA closures, training completions, and configuration changes. 21 CFR Part 11 and GMP expectations require trustworthy, attributable, and reviewable records. Use filters and exports as inspection-preparation evidence.
Current downloads are as-of snapshots, not frozen regulatory-submission dossiers.

​
Operational Reports

Reports summarize deviations, CAPAs, training, document approvals, and system activity for management review. Periodic quality review needs trend evidence, not anecdotes — reports help identify repeat issues, overdue work, and ownership bottlenecks. Run reports before quality review meetings and use the audit trail to confirm key signatures or status transitions.

​
Part 11 Context

Audit entries retain actor, entity, action, timestamp, and change details where the workflow records them. Electronic records must be trustworthy, attributable, and reviewable — when investigating an issue, use reports to confirm who changed the record, when, and what rationale was captured.

​
Report date ranges

The Audit Trail export and the change-control, training-compliance, CAPA and deviation summary reports read their date range as whole days in your organization’s time zone. The selected end date is included in full. If your organization’s time zone is not set or is invalid, the report uses UTC and its range label says so.

​
Auditor Packet (where enabled)

Where the auditor packet is enabled, Administrators and QA Managers can generate one print-ready PDF of the deviation, CAPA, change-control, complaint, training and equipment registers for a date range. See Auditor Packet.

​
Record PDFs (where enabled)

Where record PDF export is enabled, a record’s detail page offers a PDF of that record. Each record PDF lists the sections it includes and the ones it does not include, so a reader can see what the file leaves out. For example, a deviation PDF does not include the deviation timeline, and a change-control PDF does not include comments.

​
Read the aging buckets

Where closure metrics are enabled, open-record aging uses elapsed days since the record was created, not days past its due date. The buckets are 0–30, 31–60, 61–90, 91–180, and 180+. The final label means older than 180 days: day 180 stays in 91–180; day 181 enters 180+. Use the separate older cohorts to find long-running work. A record’s aging bucket does not by itself show whether it has breached its configured SLA. Review the record and its applicable due date.

​
Report access

Report lists and generated downloads are restricted to administrators and QA managers. A reference page or visible navigation item does not grant another role permission to generate or download a report. Existing reporting feature availability still applies.