How does TraceUnified compare to Ketryx?

Ketryx adds a compliance layer over the tools you already run, keeping requirements, tests, and code in their original systems and stitching the record together. TraceUnified is the system of record itself - requirements, MBSE, tests, risk, and SBOM authored in one database - so compliance is a property of the data, not an overlay you maintain across integrations.

Do I have to keep Jira, Polarion, or other tools running with TraceUnified?

No. TraceUnified replaces the stack rather than connecting it, though you can import from CSV, Word, ReqIF (DOORS, Polarion), XMI (Cameo, Rhapsody), and SBOM, and integrate any tool you keep via the REST API. You are not locked into running a hub plus its sources.

Does TraceUnified provide 21 CFR Part 11 e-signatures and an audit trail natively?

Yes, on every item. Versioned records, Part 11 electronic signatures, releases as signed evidence, and a tamper-evident audit trail are built into the platform, not assembled from connected tools.

Is it suitable for IEC 62304 software and ISO 14971 risk?

Yes. TraceUnified ships built-in frameworks for IEC 62304, ISO 14971, ISO 13485, EU MDR, 21 CFR Part 11, FDA QSR, and IEC 62443, with live coverage and gap analysis across the connected thread.

Ketryx alternative

The Ketryx alternative.

Ketryx is a strong platform, and its overlay approach is genuinely clever — it lets engineers keep their existing tools. Teams come looking for an alternative when they’d rather consolidate onto one system of record than run a compliance layer on top of the stack they already maintain.

Try for free See the full Ketryx comparison →

Why teams look

Why teams look for an alternative to Ketryx.

This isn’t a knock on Ketryx — the overlay model is a real strength for some teams. These are the reasons others want the opposite architecture.

It’s an overlay, not the system

Your requirements, code, and tests stay in Jira, GitHub, and TestRail. You keep licensing, running, and reconciling that underlying stack — Ketryx sits on top of it.

The trace is synthesized

Traceability is generated across connected tools rather than being native to one place — which means it depends on those integrations staying healthy.

No native MBSE or test authoring

Modeling and test execution live in the tools beneath the overlay, not in one governed system of record.

What to look for

What a real alternative should give you.

If you’re going to move, move to something that closes the gap for good — not another point tool you’ll wire to the rest.

One system, not a layer plus a stack. The work is authored in one place — fewer tools to license, run, validate, and reconcile.
A trace that’s intrinsic. Traceability native to a single data model, not generated from connectors that have to stay in sync.
Native breadth. SysML MBSE and test execution built in — not delegated to the tools underneath.
The same regulated rigor. Part 11 signing, ISO 14971 risk, SBOM, releases as evidence, and a complete audit trail — in the system of record itself.

Why teams choose TraceUnified

Be the system of record, not the layer over it.

TraceUnified and Ketryx aim at the same outcome — continuous traceability, an audit trail that’s a by-product of the work, and Part 11 signing. The difference is architecture. Ketryx connects your existing tools and generates compliance across them; TraceUnified is the application the work is done in.

That means requirements, architecture, tests, risk, and SBOM are authored natively as governed records, the thread is intrinsic to one database rather than synthesized from integrations, and there’s no underlying stack beneath the platform to keep running and validating.

Requirements, SysML MBSE, tests, risk, and SBOM authored in one system.
Traceability native to the data model — not generated across connectors.
Native test execution and modeling, not delegated to other tools.
One platform to license, run, and validate — with Part 11 and audit built in.

Prefer the balanced view? Read the full TraceUnified vs Ketryx comparison →

Making the move

Consolidating, not just connecting.

Moving from an overlay is less a migration than a consolidation: instead of layering compliance over Jira, GitHub, and TestRail, you bring the work itself into one system. Requirements come in via ReqIF, CSV, Excel, or Word with field mapping and traceability-link import; tests and risk are authored or imported onto the same thread.

If keeping your engineers in their current dev tools is non-negotiable, an overlay may suit you better — and we’ll say so. If consolidating onto one governed system is the goal, that’s exactly what TraceUnified is built to be.

Questions

Ketryx vs TraceUnified, answered.

How does TraceUnified compare to Ketryx?: Ketryx adds a compliance layer over the tools you already run, keeping requirements, tests, and code in their original systems and stitching the record together. TraceUnified is the system of record itself - requirements, MBSE, tests, risk, and SBOM authored in one database - so compliance is a property of the data, not an overlay you maintain across integrations.
Do I have to keep Jira, Polarion, or other tools running with TraceUnified?: No. TraceUnified replaces the stack rather than connecting it, though you can import from CSV, Word, ReqIF (DOORS, Polarion), XMI (Cameo, Rhapsody), and SBOM, and integrate any tool you keep via the REST API. You are not locked into running a hub plus its sources.
Does TraceUnified provide 21 CFR Part 11 e-signatures and an audit trail natively?: Yes, on every item. Versioned records, Part 11 electronic signatures, releases as signed evidence, and a tamper-evident audit trail are built into the platform, not assembled from connected tools.
Is it suitable for IEC 62304 software and ISO 14971 risk?: Yes. TraceUnified ships built-in frameworks for IEC 62304, ISO 14971, ISO 13485, EU MDR, 21 CFR Part 11, FDA QSR, and IEC 62443, with live coverage and gap analysis across the connected thread.

Judge it on the work

Overlay your stack — or replace it with one system.

Start a free trial and land in your own isolated workspace with a populated, industry-specific project — the whole thread, already linked. See what one connected system feels like before you commit.

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