CMC Change Impact Assessment demo
Reads a manufacturing change control, finds every registration it touches by presentation and country, cites each country's filing, and draws the global approval runway with a suggested go-live date. 1:14
What the demo shows
A regulatory CMC solution for regulatory affairs that finds the filings a plant change needs.
Six agents read the change control from the QMS, find every registration by presentation and country, quote the registered text the change touches and apply each country's rule book with a citation. The runway planner draws a bar per market from submission to expected approval and suggests the go-live date — one date everywhere or a split where a late market follows. The regulatory CMC lead decides each market, sets the date and signs.
Transcript
- CMC Change Impact Assessment finds every filing a plant change needs for regulatory CMC teams.
- One change can take years to clear every market.
- This is line B, country by country.
- A new change control arrives, a second sterile filter supplier at Cork.
- Priya builds its runway.
- Agents find 39 registrations in 21 markets and classify each one.
- 21 bars appear. China's is longest.
- Supplementary application, about 14 months.
- The GoLiv moves from April to September, the third quarter.
- China follows once approved.
- Each bar opens its market with the registered text and the rules cited.
- Pre is set September.
- The change control and supply planning are told.
- Build on Botminds, agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.