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Risk Management
ISO 14971 risk assessments with residual-risk tracking and control traceability.
ISO 14971 · ISO 13485 §7.1, §7.3.7 (21 CFR Part 820, QMSR)
What it does
Build risk assessments as a parent analysis with child risk items — each with hazard, harm, severity, probability, risk controls, and residual (post-control) scores. Severity × probability produces a banded risk level so you can see what's acceptable, ALARP, or unacceptable.
How Indelio handles it
The electronic signature at review and approval binds the entire assessment — every field and every risk item — so altering any row after sign-off breaks the binding. Risk items lock once the analysis is reviewed, so the approval signs stable content. Segregation of duties separates reviewer and approver.
Key capabilities
- ✓ Hazard analysis with initial and residual risk scoring
- ✓ Risk-control traceability bound into the signed record
- ✓ Banded risk levels (acceptable / ALARP / unacceptable)
- ✓ Whole-assessment signature binding
The whole quality system shares one audit trail.
Risk Management plus thirteen more modules — connected, Part 11, validation included.
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