Post-Market Surveillance & Complaints

This collection controls what happens after the product leaves controlled production.
It prevents complaints, PMS signals, and field issues from becoming isolated administrative exercises.

Products in this collection enforce:

  • Complaint intake and triage logic

  • Investigation depth proportional to risk

  • Mandatory escalation into CAPA

  • Required feedback into the risk management file

  • Visibility into management review decisions

The system is built around traceability, not volume.
Zero complaints is acceptable only if the intake and evaluation system is demonstrably live.

This collection is for organizations that understand auditors do not certify complaint counts.
They certify decision logic and linkage discipline.