NP-200 system security design review
NimbusPump NP-200 Program · candidate AREV-0004 vs effective baseline DRB-0007
Approval room
Readiness, the approver roster and the decision record behind baseline DRB-0007.
2 blocking failures prevent READY_FOR_REVIEW
Readiness rules
Evaluated 28 Apr 2026, 15:40 UTC
2 blocking · 1 advisory
- Blocked
- Blocked
- Conditional
- All source files are safe, parsed or explicitly excluded with rationale.Passed
- Analysis-ready gates DR-GATE-001..008 pass or have approved exceptions.Blocked
- Every confirmed threat has a risk assessment and owner.Passed
- Every high/critical or safety-linked threat has adopted mitigation or authorized acceptance request.Blocked
- Every adopted remediation has implementation and verification obligations.Passed
- No required reviewer authored the sole decision they are approving.Passed
- Architecture revision and source manifest hashes are stable for the candidate review.Passed
- Regulatory, Safety/Clinical and Privacy reviewers assigned when triggers apply.Passed
- Medium/low deferred items have due dates before configured threshold.Conditional
- Threat coverage and element coverage meet tenant targets; exclusions are summarized.Passed
Approver roster
Decides once readiness passes
System/Product Architect
Priya Raman
Cybersecurity Lead
Marcus Chen
R&D Manager
Tomas Novak
Quality / Design Control
Elena Vasquez
Safety / Clinical
Dr. Lena Fischer
Regulatory Affairs
Sam Okafor
Product Owner
Dana Whitfield
Decisions: DRB-0007
Approved with actions 19 Feb 2026 · AREV-0003
- Product Owner: ApprovedDana Whitfield · Business scope and action ownership confirmed.
- Regulatory Affairs: ApprovedSam Okafor · Submission-view scope confirmed for US premarket profile.
- Quality / Design Control: Approved with actionsElena Vasquez · Two tracked actions accepted (AWA-0007-01 update-path hardening study, AWA-0007-02 maintenance timeout).
- Safety / Clinical: ApprovedDissentDr. Lena Fischer · Approved with recorded dissent.
- R&D Manager: ApprovedTomas Novak · Implementation obligations accepted with FW 3.1.4 evidence.
Dr. Lena Fischer · Safety / Clinical
Dissent retained per spec 10.2: maintenance-mode auto-timeout (later REM-216) should have been a mandatory pre-baseline control, not a tracked action. Disagreement preserved in the baseline record; it cannot be hidden by the majority decision.
- AWA-0007-01: Update-path hardening study (led to REM-210/211 evaluation), due 30 Apr 2026.
- AWA-0007-02: Maintenance-mode auto-timeout design (now REM-216), due 28 Aug 2026.