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.
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. 
