Agentic QMS
Agentic QMS and the work queue
Change control, CAPA and document control on the same audited records as every other product, with derived workflow stages, a work queue across every product and a record graph in both directions.
In the portal: /app/qms
The QMS overview
Agentic QMS has tabs for Overview, Work queue, Change controls, CAPAs, Documents, Audit trails (administrators) and the Q Intelligence hub. The Overview shows the risk posture, recent activity and what needs attention: changes awaiting a decision, emergency or expedited changes open, CAPAs past target date, CAPAs awaiting effectiveness, documents due for periodic review and investigations with CAPAs to track.
- Person
1. Investigation or finding
Deviation, complaint, audit, signal
- Person
2. CAPA
Opened from the investigation, prefilled
- Person
3. Change control
Raised from the CAPA or investigation
- Person
4. Document revision
The procedure the change requires
- AI drafts
5. Regulatory screening
If the change may need a filing
- Person
6. Effectiveness verified
Closes the CAPA and the change
The work queue
The Work queue lists every open record across all products (complaints, investigations, batch reviews, submissions, signals, backlog triage, change controls, CAPAs, documents, validation projects and documents), plus effective documents whose periodic review is due.
- Figures: open records, overdue (and how many more are due within 14 days), and not touched in 14 days.
- Columns: record, stage, Waiting for (for example AI assessment, board decision, 2 approvals, 3 tasks, effectiveness check, signature), owner, due date and age.
- Filter by product, show only records due within 14 days or overdue, sort by due date, age, recent change or product, and search.
Derived stages
QMS stages are derived from what the record contains; nobody sets them by hand.
| Record | Stages |
|---|---|
| Change control | Proposed → Assessed → Approved → Implementing → Closed |
| CAPA | Plan → Plan approved → Implementing → Effectiveness check → Closed |
| Controlled document | Draft → In review → Approved → Effective → Periodic review due (or Obsolete) |