The integrated ALM platform for regulated, safety-critical development
TraceUnified unifies the entire development and verification lifecycle — requirements, architecture, tests, risk, and connected SBOM — in a single traceability graph, audit-ready by default. Change one artifact and every linked item flags for re-verification, automatically.
Click Analyze on a requirement and AI checks it — gaps, conflicts, weak verifiability — and proposes a rewrite, on a model you bring. It proposes; you decide. It never touches your traceability.
Start free in a populated, industry-specific workspace — not an empty shell. yourteam.traceunified.com
| Source | TC-220 | TC-221 | TC-222 | TC-223 | TC-224 |
|---|---|---|---|---|---|
| 🔒 REQ-014 Bolus dose accuracy | ✓ | ✓ | ! | ||
| REQ-015 Occlusion alarm latency | ✓ | ✓ | |||
| REQ-016 Battery low warning | ✓ | ✓ | |||
| ⚠ REQ-017 Reservoir volume display | |||||
| 🔒 REQ-018 Basal rate scheduling | ✓ | ✓ | ✓ |
The problem
Requirements in one system, architecture in another, tests in a third, risk and SBOM somewhere else. The trace between them is a spreadsheet someone rebuilds by hand before every audit — and every boundary between two tools is a seam where the thread quietly breaks. The broken link is exactly what an auditor finds.
Each tool owns one link in the chain. None of them owns the whole thread.
How it works
Requirements, architecture, tests, risk and SBOM are linked records on one model. Review, approval, versioning, training, audit, reporting, import and release work the same on every module — and a governed AI assistant reads across the whole connected model: it proposes, you decide, on a model you bring, and never edits the record.
The platform
Each pillar is a real, deep capability — not a thin module. What no point tool can offer is the connection between them: it's the same data, so the thread is intrinsic.
Author, version, and baseline requirements as governed items. Relationship rules define what may link to what, so the trace model is enforced — not left to convention. Optional AI flags ambiguous or untestable language as you write.
Activity diagrams, allocation and satisfy/verify matrices, and model validation — with elements trace-linked to requirements and tests in one database. No ReqIF round-trip, no drifting copies.
Build test plans, execute runs with pass / fail / blocked steps, track milestones, and log defects from failed results — each linked back to the requirement it verifies.
Score risks, link mitigations to requirements and tests, and surface residual risk. When a mitigation changes upstream, the linked risk flags for review.
Import CycloneDX and SPDX bills of materials, reconcile components by package URL, and track vulnerabilities against the components your product actually ships.
See it in action
Start free in a populated, industry-specific workspace — the whole thread, already linked. Not an empty shell.
Governed AI
TraceUnified's AI is a governed advisory layer. The agents analyze and propose — they never write to your records. A human applies every change through the signed, audited workflow. AI is additive, never authoritative — the thread stays deterministic, every link still explicit and human-made.
OpenAI · Azure OpenAI · Anthropic · your own endpoint
See how the governance works →The derivation engine
Point the engine at a set of requirements and it proposes the downstream work products they imply. Every item cites a real source; you accept what's right. The record only ever changes by human action.
Connected SBOM
The FDA now requires a machine-readable SBOM in premarket submissions for connected devices — and can refuse one that's missing it. But a component list in a separate tool answers nothing when a CVE drops. In TraceUnified every component is a first-class item on the same trace graph as your requirements, risks, and tests — so a vulnerability flags exactly which hazards it threatens and which tests cover it.
1 upstream · 2 downstream · CVE flagged → 1 risk now suspect, re-verification required
Compliance spine
The controls a regulated submission depends on are part of the data model, working across every artifact in the thread — engineered to enable 21 CFR Part 11 compliance.
One spine, configured to the standard you answer to:
Industries
One traceability model, tuned to the standard you answer to. We lead where we're sharpest — medical device — and bring the same spine to every safety-critical domain.
The sharpest fit — design history, V&V traceability, risk, and e-signatures in one record. Demo content ready today.
Objectives traced from requirements through verification.
Functional-safety work products linked across the lifecycle.
Safety functions traced to tests and evidence.
One model from spec to verification.
See it for yourself
Start a free trial and land in your own isolated workspace with a populated, industry-specific project — the whole thread, already linked. Judge it on the work.
yourteam.traceunified.com