Indelio
AI-native quality management · 21 CFR Part 11 / GAMP 5
Start free trialSign in
← Indelio
⚠️

Nonconformances

Log, disposition, and close nonconforming material and process.

ISO 13485 §8.3 (21 CFR Part 820, QMSR)
What it does

Record nonconforming material or process, decide a disposition (use as is, rework, repair, scrap, return to supplier), and close it under control. A nonconformance can escalate to a CAPA when the problem needs systemic correction, and can name the supplier it originates with so it lands on that supplier's file.

How Indelio handles it

A controlled lifecycle (Open → Disposition → Pending Closure → Closed) with electronic signatures at disposition approval and closure, and segregation of duties between the two. When a supplier is named, the disposition cannot be approved until a supplier action is decided — no action (with its reason), notify the supplier, or recommend a hold or re-evaluation — and the disposition signature binds it. The NC never changes the supplier by itself: a recommendation is shown on the supplier record until someone with authority acts on it or signs why no action is needed. Every step is on the immutable audit trail.

Key capabilities
  • ✓ Standard disposition options with justification
  • ✓ Escalation to CAPA for systemic issues
  • ✓ Names the supplier implicated, with a signed supplier action recorded on the supplier's file
  • ✓ E-signed disposition and closure with segregation of duties
The whole quality system shares one audit trail.
Nonconformances plus thirteen more modules — connected, Part 11, validation package included.
Start free trialSee pricing
Explore the rest of the suite
📄Document ControlControlled lifecycle, e-sign, controlled PDF🔁Change ControlImpact assessment + approval📣Customer ComplaintsIntake, investigation, MDR decision📈Post-Market SurveillanceTrend detection across complaints & nonconformances
Security & Compliance·FAQ·Pricing