Local Label Deviation Review demo
The CCDS, the local label in its own language and a back-translation, side by side, row by row: each meaning classified as aligned, acceptable deviation or unjustified, compared by meaning rather than by matching words. 1:13
What the demo shows
A labeling compliance solution for regulatory affairs that checks local labels against CCDS.
When a local label arrives, six agents read it in its own language, write a back-translation, pair every sentence with its CCDS meaning wherever the national template puts it, classify each row as aligned, acceptable deviation or unjustified (critical, major or minor), check the justification register and draft each fix. The comparison is by meaning: a sentence that keeps 85% of its words but turns 'interrupt treatment' into 'use with caution' is caught. The medical risk assessor decides every deviation; the corrected local text goes to the affiliate, and the deviation register is signed for inspection.
Transcript
- Local Label Deviation Review checks local labels against the CCDS for regulatory affairs teams.
- A warning softened in a local label often goes unseen until inspection.
- This morning Brazil's Beulah arrived, 18 pages in Portuguese.
- One click, five agents read it, back-translate it, and pair every sentence with the CCDS.
- Then every row is classified, aligned, acceptable deviation, or unjustified.
- The liver row turns red.
- Interrupt treatment has become used with caution.
- 85% of the words still match.
- A word check passes it.
- Reading for meaning does not.
- Maya confirms it as critical.
- The corrected Portuguese goes to Ana Ribeiro.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.