Computerized System Periodic Review demo
Each validated system's year laid out month by month from its own records, the gaps against the SOPs found, and the periodic review drafted for sign-off. 1:09
What the demo shows
A GxP compliance solution for system owners and QA that drafts each validated system's review.
Read-only agents pull the period's changes, incidents and problems, deviations and CAPAs, access certifications, backup and restore tests, audit-trail reviews and last year's actions. They place each one on a year calendar against what the SOPs expect, mark the gaps, and draft the ten-section review with a citation for every statement. IT Quality decides each finding and signs, then the system owner approves.
Transcript
- Computerized System Periodic Review drafts each validated system's review for system owners and QA.
- Here is ChromaVault, the Leiden Labs Chromatography System.
- Its Year of Evidence sits in six tools.
- Load the year, agents' read changes, deviations, access reviews, backups and audit trails.
- Each record lands on its month.
- Dashed rings show what the procedures expect.
- Then a gap. 16 weeks without an access review, while two leavers kept their accounts.
- The finding drafts beside it, every statement cited.
- Three more gaps follow, and the review opens already drafted for Omar.
- He raises the action, the review drafted in hours, not days.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.