Batch Disposition & QP Release demo
Sets six release gates for every batch (batch record, deviations, QC results, environmental monitoring, changes and markets, stability), each from cited records, and keeps the QP's signature locked until all six are clear. 1:13
What the demo shows
A GMP batch release solution for Qualified Persons that builds the pack and shows blockers.
When the last QC result is released, a release coordinator opens six gates over the 18 checks of EU GMP Annex 16 and sends each to a specialist agent: batch record and materials, deviations and OOS, QC results and CoA, environmental monitoring, changes and markets, stability. Each gate comes back clear, to review or blocked, citing the records behind it; a blocker names its owner and is re-checked when the record changes. The QP opens any gate to read its evidence, accepts what needs review, and can certify with an e-signature only when all six are green; the certificate, register entry and ERP stock status follow.
Transcript
- Batch Disposition & QP Release sets six release gates for each batch for the QP who signs.
- By hand, the evidence takes two and a half days to gather from seven systems.
- For Batch VL 26-0418, six agents check the record.
- Results, deviations, environment, changes, and stability.
- Deviations is blocked. A bulk hold ran long.
- and QA has not approved.
- Lina asks Omar. He approves and the gate turns green.
- Five gates green. Environmental monitoring is amber.
- One excursion linked. She reads it, accepts it, and the signature unlocks.
- She certifies for five EU markets.
- Every blocker named, every record cited.
- Built on Botminds: agents, data, screens and governance on one platform. more.
Transcribed from the film’s narration. Captions are on the player.