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From change submission → impact mapping → risk scoring → audit-ready evidence.


        
Change IDCT-2025-000913
Submitted Bym.chitwood@chieftrace
SystemMed Firmware v1.4.8
Timestamp2025-03-12T14:22:51Z
ReasonCVE-2025-1021 patch
Change Verification Tests Risk Management SOP-12 Update

Edges are discovered via trace links (Req ⇄ Design ⇄ Tests ⇄ SOPs). Affected nodes are highlighted.

0%
I = B×C×P×R×A×D (configurable weights) • current scenario: 74%
Audit Evidence Package

          
Meets FDA 21 CFR Part 11 electronic records / signatures expectations.

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