We believe in transparency. Here's exactly what NirmIQ can do today for compliance, what's partially implemented, and what's on our roadmap.
Core compliance features that are fully implemented and production-ready
Link requirements to tests, FMEA, and design elements with full upstream/downstream navigation
Every change tracked with timestamp, user, and reason. Immutable history for regulatory evidence
Full AIAG/VDA FMEA with structure tree, RPN calculation, and action tracking
Create baselines, compare versions, and maintain complete change history
Granular permissions with Row-Level Security at the database level
Connect every safety requirement directly to its failure mode analysis
FDA-compliant digital signatures with re-authentication, document hash verification, and full audit trail for approvals, reviews, and verifications
5-level hierarchical requirements (System, Subsystem, Component, Design, Verification) with parent-child traceability across all levels
Full electronic signature capability for regulated industries. Sign FMEA analyses, requirement baselines, test reports, and documents with complete traceability.
Password verification required at time of signing. MFA support included.
SHA-256 hash verification ensures documents haven't been altered after signing.
Every signature recorded with timestamp, user, IP address, and signing meaning.
Approved, Reviewed, Verified, or Rejected — each signature carries explicit intent.
Features that work today with enhancements planned
ASIL/DAL/SIL classification via custom fields. Auto-propagation on roadmap.
Traceability, coverage, and compliance reports with export.
Process evidence for ASPICE assessments including ENG.1 through ENG.6, MAN.3, and SUP.8.
Features we're actively building for future releases
Pre-built PSAC, SDP, SVP, SRS, SDD templates
Export safety cases in Goal Structuring Notation format
TQL-5 qualification documentation for DO-178C/330 projects
Software of Unknown Provenance tracking for IEC 62304 medical device projects
Detailed status for each industry standard
ISO 26262 / ASPICE
| Feature | Status | Note |
|---|---|---|
| ASIL classification tracking | Ready | Via custom fields |
| FMEA with RPN calculation | Ready | AIAG/VDA compliant |
| Traceability matrix | Ready | Full bi-directional |
| ASPICE ENG.4 traceability | Ready | Requirements to tests, FMEA, design |
| ASPICE SUP.10 change management | Ready | Full audit trail, baselines |
| ASPICE ENG.5 risk analysis | Ready | FMEA with action tracking |
| ASPICE ENG.6 verification | Ready | Test cases linked to requirements |
| ASIL auto-propagation | Roadmap | Q3 2026 |
| Safety case export | Roadmap | Q3 2026 |
DO-178C / ARP4754A
| Feature | Status | Note |
|---|---|---|
| DAL classification tracking | Ready | Via custom fields |
| Requirements traceability | Ready | All levels supported |
| Change impact analysis | Ready | Real-time updates |
| DO-178C templates | Roadmap | Q2 2026 |
| Tool qualification (TQL-5) | Roadmap | H2 2026 |
IEC 62304 / FDA 21 CFR Part 11
| Feature | Status | Note |
|---|---|---|
| Software safety classification | Ready | Class A/B/C tracking |
| Risk management (FMEA) | Ready | Full RPN workflow |
| Audit trail | Ready | Complete change history |
| 21 CFR Part 11 e-signatures | Ready | Re-auth, hash verification, audit trail |
| Signature meanings | Ready | Approved, reviewed, verified, rejected |
| Document integrity | Ready | SHA-256 hash verification |
| SOUP management | Roadmap | Q3 2026 |
We're happy to discuss your specific compliance needs and whether NirmIQ is the right fit.