Customer Complaints
From intake to a documented reportability decision to CAPA.
Capture, evaluate, investigate, and close product complaints, with a documented reportability decision and trending. A structured worksheet captures everything an investigator needs; the reportability decision records whether the event is MDR-reportable and the rationale. Indelio does not calculate or track MDR submission due dates — the 30-day and 5-day reporting clocks run under your own procedure.
Complaints can also arrive by email, through a forwarder your organization connects to Indelio's intake endpoint. Each email is stored as a triage item; by default the AI reads nothing until QA or an administrator releases it, and then proposes the fields — and a human always confirms before it becomes a complaint (AI proposes, a person disposes). Investigation and closure each require an electronic signature with segregation of duties, and a complaint can escalate directly into a linked CAPA.
- ✓ Email intake through your own forwarder — the AI reads a message only when you allow it, and a person confirms
- ✓ Documented MDR reportability decision and rationale
- ✓ One-click escalation to a linked CAPA
- ✓ Trending and management-review inputs