Why TraceUnified
The work of a regulated product — requirements, architecture, tests, risk, SBOM, traceability, sign-offs, releases, compliance, and training — lives today across half a dozen tools that don't talk to each other. Each is a license. Each is an integration to maintain. And the traceability between them is a spreadsheet someone rebuilds by hand before every audit. TraceUnified is all of it, on one connected model of record.
One data model · one audit trail · the thread never breaks.
The status quo costs you twice
The first cost is the obvious one — a license for each system, and an integration to keep each pair of them in sync. The second cost is quieter and larger: the trace that lives in the seams. Every boundary between two tools is a place the thread breaks, and the broken link is exactly what an auditor finds. Teams lose weeks reconstructing coverage before a submission, and rework lands late because a change in one tool never reached the others.
Five to eight separate products, each priced per seat, each renewed every year — for capabilities that overlap and still don't connect.
The connectors between them are yours to build, test, and maintain — and they drift. A sync that silently fails is a thread that silently breaks.
Coverage matrices rebuilt by hand in a spreadsheet, evidence chased across systems, weeks burned before every submission — work that proves nothing new.
One platform, not a toolchain
Every discipline here is a deep, native capability in the product — not a thin module, and not a bridge to someone else's tool. Because it's one data model, the connection between them isn't an integration you maintain. It's just there.
One login · one data model · one audit trail.
Point tools each own one link in the chain. TraceUnified owns the whole thread.
What you get that a toolchain can't
Any one of these you could find somewhere. What no stack of point tools can give you is all of them on the same thread — so the whole lifecycle stays honest as it changes.
Requirements, architecture, tests, risk, and SBOM are records in one database, not systems wired together. Change one item — even a vulnerable component — and every linked item flags suspect for re-verification, automatically. No integration to drift, no seam to break.
Every change is versioned with who, when, and why — as a by-product of the work, not a binder assembled before a submission. Verification shows coverage and gaps against your frameworks live, so an audit is a report you run, not a fire drill.
Controlled transitions, approvals, and releases are signed with re-authentication and a recorded signature meaning — the binding, attributable signature Part 11 requires, enforced by the system rather than promised in a policy.
Score hazards on the ISO 14971 model, link mitigations to the requirements and tests that deliver them, and accept residual risk on the record. Import CycloneDX or SPDX, and when a CVE lands, every dependent item flags for re-assessment.
SysML elements — block, internal-block, parametric, state-machine — are first-class items in the same database as your requirements and tests. No ReqIF export-import, no drifting copies, no drawing pinned to a ticket.
Optional AI flags ambiguous, untestable, or incomplete requirements as you write them — on a model you bring. It assists the author; it never writes your traceability. The system of record stays yours.
Bundle requirements, architecture, tests, and risks, baseline them as named snapshots, clear the readiness gates, and sign. The submission assembles itself from the evidence that actually exists — fixed to exactly what was approved.
Coverage matrices, verification status, and risk burndown come straight from the system of record — export to Word, Excel, or PDF, or schedule them. You never rebuild a traceability matrix in a spreadsheet again.
Built to the standard, not to a deadline
TraceUnified is built to the benchmark set by Jama, Polarion, and DOORS — every capability deep enough to run a real program on, with the controls a regulated industry can't compromise.
Your own dedicated workspace at yourteam.traceunified.com — with VPC isolation and a BAA available for teams that need them. Run it in our cloud or self-hosted.
Versioned records, controlled states, enforced relationship rules, lock management, and a complete, exportable audit trail — the controls are the architecture, not a setting.
SSO, roles and permissions, groups, and per-project access — so the right people see the right work, and every change is attributable.
See it on your own work
Start a free trial and land in your own isolated workspace with a populated, industry-specific project — the whole thread, already linked, end to end. Judge it on the work, not on a pitch.
yourteam.traceunified.com