For quality & regulatory

Audit-ready documentation, without the fire drill

For QA and regulatory affairs teams: keep requirements, risks, and verification traceable and controlled, so submissions are ready before the project ends and audits become an export.

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Evidence, produced as you work

Live traceability

See coverage through a requirements traceability matrix and a visual Document Map, with broken-trace detection so gaps surface early.

Controlled documents

A published, draft, and fix version model with gated review, e-signatures, a change log, and an immutable snapshot on publish. See document control software.

Standards-aligned

Templates aligned with IEC 62304, ISO 13485, and ISO 14971, so teams start from the right structure.

Free auditor access

Reviewer and Auditor seats are free, so bringing an auditor in does not add cost.

Audit as an export

Immutable snapshots, change logs, and e-signatures mean the evidence is already assembled when it is asked for.

Submissions ready early

Because traceability and control are live, submission packages come together throughout the project, not at the end.

Common questions

How does Traceable help with audits?

Coverage is visible in a requirements traceability matrix, every published document carries an immutable PDF snapshot, changes are logged, and approvals are captured with e-signatures. When an auditor asks how a requirement was verified, the answer is an export rather than a scramble.

Does Traceable support our quality system standards?

Templates and features are aligned with standards such as IEC 62304, ISO 13485, and ISO 14971. Traceable helps you produce and trace the documentation these standards expect. Certification depends on your quality system and your auditor, not on any tool.

Can external auditors access documents without a paid seat?

Yes. Auditor and Reviewer roles are free, so you can give an auditor read access without adding a paid seat.

Pilot plan

Put Traceable through its paces on a real project

Manage your risk before you commit: pick a live project, run it in Traceable, and judge it on your own documents.

Start with no cost

Pick a real project and run it in Traceable, with our team alongside you and onboarding and training included.

Support with setup

Your core requirements imported for you, a named contact and a weekly check-in.

Measured on your documents

Requirements linked and traced, a document reviewed, signed and published, and a PDF your eQMS accepts as is.

Your call at the end

Carry on with a plan, or stop. If you stop, we return your data to you and then delete it.

Turn audits into exports

Import your existing documentation and see live traceability and control in minutes.

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