Describe what was reported. The co-pilot suggests both axes — clinical manifestation and software failure mode. You confirm before it becomes a case.
Adverse events mapped to the software version in use at event time — the view a molecule-centric safety system can't produce.
intake → classified → assessed → signed-off. Assessment needs Assessor or QPPV; sign-off needs QPPV.
Register each product under surveillance and log every software release. The version axis is what makes signal detection version-stratified — keep releases current.