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.
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; it does not by itself make an organisation certified.
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.
Turn audits into exports
Import your existing documentation and see live traceability and control in minutes.