Audit Trail Review demo
Every person's audit-trail events as a lane across the week — deletions, back-dating and repeated reprocessing flagged with the log rows behind them — on a review schedule set by each system's risk. 1:15
What the demo shows
A GxP data integrity solution for QA that flags deletions, edits and back-dating in logs.
Agents collect each system's audit trail on its risk-based schedule, map every event to the person behind it, and lay the week out as one lane per person. Rules and 90-day baselines flag deletions, back-dating, clock changes, shared accounts, self-approval and repeated reprocessing, each with the exact log rows. The data integrity reviewer decides every finding and signs the period's record; a High finding moves the system to a more frequent schedule, with the SOP rule cited and QA's approval.
Transcript
- Audit Trail Review is a GXB data integrity solution that lets QA review every audit trail, person by person.
- Half a million log rows a week, and QA samples one in five.
- Here, each person is a lane.
- Yours for Mulan's Thursday is flagged.
- Three reprocessing events in an hour, before the result was reported.
- The assay failed at 94.1.
- The third reintegration read 95.3 and was signed.
- Every statement cites its log row.
- PRIA opens a deviation on evidence.
- Environmental monitoring had a high finding, so its reviews tighten, citing SOP rule 5.5.
- PRIA applies it, QA approves, and 10 weeks update.
- every period reviewed on schedule and signed every row screened built on Botminds agents data screens and governance on one platform
Transcribed from the film’s narration. Captions are on the player.