← Indelio
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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.
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. Every step is on the immutable audit trail.
Key capabilities
- ✓ Standard disposition options with justification
- ✓ Escalation to CAPA for systemic issues
- ✓ 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 included.
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