TraceableAudit ready the day you need it

Spend less time on paperwork and more on your product

One secure, AI-connected workspace for every document, review and signature, so your team ships sooner with less overhead.

Authoring

Working with

See it work

Traceable in a few minutes

A walk through the workspace: authoring a document, linking requirements across it, and publishing with signatures captured.

Why use Traceable?

Release regulated products faster, with less overhead.

Here is what slows regulated teams down, and what changes when the work lives in one place.

Holding you back

Files were never meant to manage a live design

“Keep it simple” is a good rule, but a product worth certifying is not simple. Files are passive: they cannot link a requirement to the test that proves it, version themselves, or show you the state of the whole design.

Every step in the flow adds another tool

Count them. From the first requirement to a formal release: template, document number, folder, authoring, review, export, publish, then a design change and around again. Every hop is somewhere work gets duplicated, delayed or lost.

Every role needs something different, and now so does AI

Engineering, quality, regulatory and approvers each need something different from the same document, and AI now drafts alongside them. A person still has to approve and sign it. One tool has to serve all of them and stay audit ready.

The solution

Live traceability that can’t silently break

Every requirement is linked, and those links stay valid as the design changes. Versioning is automatic, and the whole design stays visible in the traceability matrix and the document map.

One workspace, first draft to signed release

Start from templates built for the standards you work to. Numbering, authoring, review, approval and publishing all happen in one place, so there is no flow to map across tools and nothing to re-key.

Something for everyone in a controlled environment

An intuitive interface for writers, reviewers and approvers, an MCP for developers and a requirements tree for systems engineering. Every AI contribution, internal or external, is logged and needs human acceptance before it can be published.

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What you retire

Four tools become one

Word, SharePoint, a separate e-signature tool and a traceability spreadsheet, replaced by one controlled workspace.

  • AuthoringWord documentsA familiar document editor with regulated templates
  • Storage and versionsSharePoint folders and version historyAuto-versioning, draft and published, in one place
  • Review and signaturesEmail threads and a separate e-signature toolBuilt-in review, with FDA 21 CFR Part 11 compliant e-signatures on the Regulated plan
  • TraceabilityA spreadsheet or a requirements tool export, kept by handLive trace links, a trace matrix and a Document Map
  • PublishingSaving to PDF and filing it by handA searchable PDF generated on publish

See Word and SharePoint compared with Traceable

Key features

Everything a regulated team needs, in one place.

From the first requirement to a signed release, without leaving the workspace.

01

Document templates

Start every document from a structured template built for the standard you work to. Nobody begins from a blank page.

02

Review & approval

Reviews, deadlines and electronic signatures happen inside the document, and the audit trail writes itself as you go.

03

Version control

See who changed which requirement and when, compare any two versions, and roll back without losing the record.

04

Live traceability

Requirements, risks and tests stay connected as documents change, and a broken link surfaces before an auditor finds it.

05

Structured content

Requirements, risks and tests are data you can filter, link and report on, not paragraphs to search through.

06

Any document type

Set up any document type, template and ID prefix, and choose who reviews and signs each document. Traceable fits the way your team already works.

How it works

From blank page to audit-ready, in one controlled flow.

Author, trace, control, review and publish. Each step hands the next one everything it needs.

Available now · Release 1
01

Author

Write in a structured canvas from templates for the standards you work to: text, tables and requirement grids, not loose prose.

TemplatesAuto-save
02

Trace

Give every requirement a TraceID and link it across documents. Coverage stays live in the matrix and the document map.

TraceIDsRTM
03

Control

Every draft keeps a row-level change log with comments and mentions, under a published, draft and fix version model.

Change logComments
04

Review & sign

Nothing publishes until comments are resolved and e-signatures are captured, each with the signer’s identity and a timestamp.

e-SignaturesGated release
05

Publish

Each release locks an immutable PDF snapshot and generates the revision table from the document’s own published history.

PDF snapshotRevision table
Built for regulated industries

Compliance, by design.

Traceable is built for teams working to these standards. It keeps the evidence an audit asks for as you work, so the audit becomes an export, not a project.

IEC 62304 · Medical device software lifecycleISO 13485 · Medical device QMSISO 14971 · Risk management21 CFR 820 · FDA QMSR21 CFR 11 · Electronic records & signaturesISO 9001 · Quality managementDO-178C · Airborne softwareMIL-STD-882E · System safety
The team

One source of truth for every role on the project.

Traceable replaces a dozen disconnected tools with a single hub, so every role works from the same live documents.

Project Manager
Systems Engineer
Quality Engineer
Software Developer
Test Engineer
UX Designer
Regulatory Affairs
Marketing
Supplier
Executive
Enterprise AI
Project Manager
Systems Engineer
Quality Engineer
Software Developer
Test Engineer
UX Designer
Regulatory Affairs
Marketing
Supplier
Executive
Enterprise AI

Reviewers and auditors are always free, so everyone who touches the design history can be in it.

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.

Bring your next release into Traceable.

Book a demo and we will walk through your documents, your standards and how your team works today, or run a real project in Traceable on a pilot plan.