Every write in Swat iQua Suite and its audit trail row are committed in one database transaction, with a mandatory reason for the change and the site where the work was done. That gives you a complete record. Data integrity guidance expects more: that the audit trail is actually reviewed. This page brings together the three tools that do that.
The audit trail report
The audit trail report is read-only and spans every module’s logs. Filter by site, module, date range, user and activity; open a single record to see its own trail together with related records up to two levels deep. Results are always newest first, date ranges and row caps keep queries fast, and a visible warning appears when results are truncated. Exports go to A4-landscape PDF or Excel, and each export is itself logged.
Periodic, risk-based audit trail review
Reading every entry is not realistic. The audit trail review highlights the entries most likely to matter, using five automatic risk-signal detectors:
- deletions and voids;
- privileged (admin) changes;
- configuration changes;
- after-hours activity;
- changes after approval — treated as critical.
Signals are frozen when the reviewer starts, so the review can be reproduced exactly later. A finding raises a CAPA in CAPA Management, and QA approves the completed review with an e-signature.
Second-person raw data review
For the lab, a second person can review raw data behind a test result or instrument run and record an e-signed outcome of finding or no finding. The reviewer cannot be the analyst. A finding raises a deviation automatically in Deviation Management. This review complements the result review already built into Sample & Testing Management in the LIMS.
Second-person raw data review is one of the newer capabilities in Swat iQua Suite and is intentionally focused; the audit trail report itself is mature and used across the platform.