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Customer Complaints
From intake to reportability decision to CAPA — with the MDR clock handled.
ISO 13485 §8.2.2 · 21 CFR Part 803 (MDR) · 21 CFR 820.35 records (QMSR)
What it does
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.
How Indelio handles it
AI email intake reads an inbound complaint email and proposes a triage record — but 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.
Key capabilities
- ✓ AI-assisted email intake with human confirmation
- ✓ Documented MDR reportability decision and rationale
- ✓ One-click escalation to a linked CAPA
- ✓ Trending and management-review inputs
The whole quality system shares one audit trail.
Customer Complaints plus thirteen more modules — connected, Part 11, validation included.
Explore the rest of the suite