Signal Layer
Agents monitor FDA, quality, supplier, batch, submission, and field-safety signals.
Events are normalized with source metadata, severity, confidence, and provenance before they reach an operator.
// 05 / Selected Path
Pharma & Devices.
FDA
LOT
QMS
Intelligence Loop
Turn external change into accountable action.
For pharma & devices, CMD acts as the command layer between the signal environment and the people who own the response. Agents watch the outside world, Convex keeps the operating model live, and every brief carries sources, confidence, routing, and provenance.
Exposure Map
CMD resolves each signal against lots, products, vendors, qms.
The platform links change to dependency paths, commitments, timing, risk windows, and affected operating teams.
Agent Brief
The system explains what changed, what it affects, and why it matters.
Briefs carry sources, confidence, impact, recommended action, and the context needed for human review.
Owner Action
Work routes to quality, regulatory, manufacturing, and product owners.
The loop is accountable: protect release decisions, quality records, and patient-impact workflows, with action status and audit trail preserved.
Live Objects
Lots, products, vendors, QMS
Watched Signals
Quality events, suppliers, FDA signals, batch exposure
Decision Owners
quality, regulatory, manufacturing, and product owners
Outcome
protect release decisions, quality records, and patient-impact workflows
// Route Briefing
Send the operating surface. CMD builds the briefing loop.
A useful first brief needs the surface, source environment, operating objects, and owner path. From there, CMD can model how agents should watch, map, brief, route, and preserve decisions.