UDI Data Reconciliation (GUDID and EUDAMED vs Label) demo
Six systems held to the released label: 60 attributes per device identifier compared under the symbol they describe, and one fix applied to its whole family. 1:28
What the demo shows
UDI reconciliation for device makers: GUDID, EUDAMED and ERP records checked against the label
Seven agents read each device identifier's released label and instructions, pull its record from six systems and line every value up under the symbol it describes, across 60 attributes. They check whether a change is an edit or needs a new identifier under 21 CFR 830.50 and the EU rules, draft each correction in the target database's own field and wording, and follow the cause to every identifier that shares it. The UDI data steward approves a batch only after opening its sample, a labeling specialist checks the same records against the artwork, batches over 500 identifiers get the director's second approval, and regulatory affairs submits. The agents read back what was published.
Transcript
- UDI Data Reconciliation checks each identifier's GUDID, EUDAMED and ERP records against its label.
- Stewards: one fact, six systems plus the IFU, and GUDID locks core fields after seven days.
- Values line up under each symbol. GUDID: no MRI safety information. The label: MR Unsafe.
- It drafts the GUDID correction, checks no new identifier is needed, and finds 140 siblings.
- Batch B-14 goes to the steward. She opens five sampled records herself.
- Each shows the template, GUDID, and the edit.
- Each counts after three seconds and her verdict.
- One click never signs the whole batch.
- All five match. She signs as herself, with her user ID and password.
- Approved and logged: 282 corrections on 141 identifiers, now with labeling for its check.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.