Supplier Change Notification Impact Assessment demo
A supplier's item codes traced to our finished devices and to the validations resting on the old line, with the filing letters drafted to sign. 1:28
What the demo shows
A supplier change notification tool for device quality teams: each notice traced to its filings
Agents read each notice, map the supplier's items to our part numbers and finished devices, quote the quality agreement, find the validations and design records that rest on the old way, and draft the filing assessment. Owners sign each gate, the engineer decides with conditions, a manager checks, and the conditions reach the approved supplier record with a receiving block.
Transcript
- Supplier Change Notification Impact Assessment traces supplier change notices, for device quality teams.
- Purchasing controls drew 190 FDA device inspection observations in fiscal 2025.
- Six gates: 37 of our parts, 12 screw families, approval required.
- At gate four, the new line covers solid screws only: 4 cannulated families need revalidation.
- Gate six drafts a letter to file; EU shipments wait for the notified body.
- Mina, in regulatory affairs, signs the filing assessment first.
- Then Seraphina, in supplier quality, reads the sources and accepts with two conditions: three lots fully inspected, and the report before shipment.
- Line 5 lots and EU shipments are held at once.
- Every signature lands in the audit trail.
- One notice, traced in under two minutes, every answer sourced.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.