Supplier Document Classifier
Classify incoming supplier documentation for the QMS intake queue.
- Status
- Retired
- State
- Retired
- Owner
- Bron Helstrom
- Readiness
- 68
- Blockers
- 2
Controlled evolution states, in advance, how this AI System is allowed to change. It is the source of the predetermined change control plan, not a separate document.
Key details
The evolution boundary as agreed. Everything below is read from it.
No controlled evolution boundary is recorded. A planned modification cannot be authorised until the boundary exists.
Planned modifications
Part 1 of a predetermined change control plan. Each row is one specific, planned change.
A change described before it is made, with its acceptance criteria.
Modification protocol
Part 2 of the plan, in the four parts the FDA expects: data management, re-training, performance evaluation and update procedures.
Impact assessment
Part 3 of the plan: the benefits, the risks introduced, the mitigations and the cumulative effect of the modifications together.
Change authorisation
The change authorisation gate reads the same findings shown on the governance map.
| Gate | Outcome | Open blockers |
|---|---|---|
| Change authorisation | Held | Not recorded |
When the boundary, the modification protocol and the impact assessment are complete, the predetermined change control plan is assembled on the PCCP tab.