Deviation & CAPA Management demo
The fishbone fills itself from the records; every cause shows its evidence for and against, and every CAPA aims at the cause. 1:12
What the demo shows
A GMP investigation solution for QA that gathers evidence and proposes root causes and CAPAs.
The moment a deviation is reported, agents read the batch record, equipment, maintenance and room logs for the event window and fill the six bones of the fishbone; the root-cause analyst proposes a cause with its evidence for and against and ties each CAPA to that cause; QA reviews and signs.
Transcript
- Deviation & CAPA Management helps GMP quality teams fix the real cause of every deviation.
- Investigations stall while people chase records, and up to one in five deviations comes back.
- Dana works from a fishbone, and every cause carries its records.
- At 9.50, Line 1 reports nozzle for filling light, and the agents check every bone.
- The machine bone fills with maintenance records, a seal at 1,840 hours, rated for 1,500.
- The agent proposes a worn nozzle seal, citing three records, and shows what argues against it.
- The kappa fixes the cause on every line, not the symptom.
- Dana signs, well inside the 30-day target.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.