Every metric retains its source, period and the QPPV decision recorded against it. · Illustrative product experience.
How the work moves, end to end.
What enters
Case-processing status, literature surveillance, aggregate-reporting timelines, signal status, vendor delivery, safety-agreement obligations and regulatory commitments.
What is assessed
Compliance-metric evaluation against agreed timelines, deviation detection, vendor-performance review and inspection-readiness scoring.
What action follows
Escalation to accountable owners, CAPA initiation, obligation follow-up and preparation of the PV system master file evidence pack.
What evidence remains
Metric source, calculation period, deviation rationale, escalation record and QPPV sign-off with timestamp.
