Change Control Impact Assessment demo
Grows each GMP change into a cited impact tree of every SOP, validated system, specification, product and market filing it touches, and adds the branches similar past changes needed. 1:15
What the demo shows
A GMP change control solution for QA that lists every SOP, system and filing a change touches.
Seven agents read the change request, search procedures, validated systems, equipment, specifications and registrations in parallel, and grow a cited impact tree with every branch tied to the passage that proves it. A Past-Change Comparer then reads the most similar closed changes and adds any branch they needed that this change lacks, in amber. QA accepts each branch, Regulatory CMC confirms the filings, the board votes and the chair signs; the implementation plan follows automatically.
Transcript
- Change Control Impact Assessment shows QA everything a GMP change touches before the board.
- Owners list what they know.
- This bag supplier change lists three items.
- Grow the tree, seven agents search procedures, systems, specifications, and filings.
- Branches appear, batch records, the MES label rule, 10 market filings.
- Past changes are compared, and two filings the owner missed turn amber.
- Japan names the bag material.
- The UK never adopted Corvena's lifecycle plan.
- Each branch opens its proof.
- QA accepts it or marks it not affected.
- The board approves 31 sighted items, signs, and the plan follows.
- Every affected SOP, system, and filing listed before the board meets.
- Built on Botminds: agents, data, screens, and governance on one platform. You
Transcribed from the film’s narration. Captions are on the player.