Retire the Word, SharePoint and e-signature loop
Most regulated teams write in Word, file in SharePoint, sign in a separate tool and trace in a spreadsheet. Traceable does all four jobs in one place, and still feels like writing a document.
Word and SharePoint work for general documents, but design controls need more: links between requirements and the tests that verify them, a controlled draft and published history, and signatures that stand up to an audit. Traceable keeps the familiar document feel and builds those in, so there is one tool where there used to be four.
One place for every job in the loop
Each row is a tool or a manual step your team can switch off.
| Job | In Traceable | Today |
|---|---|---|
| Authoring | A familiar document editor with regulated templates | Word documents |
| Storage and versions | Auto-versioning, draft and published, in one place | SharePoint folders and version history |
| Review and signatures | Built-in review, with FDA 21 CFR Part 11 compliant e-signatures on the Regulated plan | Email threads and a separate e-signature tool |
| Traceability | Live trace links, a trace matrix and a Document Map | A spreadsheet or a requirements tool export, kept by hand |
| Publishing | A searchable PDF generated on publish | Saving to PDF and filing it by hand |
Traceable vs Word and SharePoint
The same comparison the other alternatives get, row for row.
| Traceable | Word and SharePoint | |
|---|---|---|
| Document authoring | WYSIWYG (what you see is what you get) document editor with regulated templates | Familiar word processor, with no requirement structure |
| Scope | Complete design documents, from blank page to published, with reference file storage | General documents in Word, stored in SharePoint, with signatures in a separate e-signature tool |
| Reference files and citation | Reference library with versioned files, numbered citations and reference tables built automatically | Files in SharePoint libraries, cited by hand |
| AI authoring through the Model Context Protocol | Official connector: an AI assistant can read and author documents, requirement rows and trace links under your own permissions | Microsoft 365 Copilot assists in the document, with no requirement-aware connector |
| Review and e-signatures | Built-in review with e-signatures and an audit trail, with FDA 21 CFR Part 11 compliant e-signatures on the Regulated plan | Comments and tracked changes, with signatures through a separate e-signature tool |
| Published documents | Searchable, clickable PDF, generated automatically on publish or exported at any time | Saved to PDF by hand |
| Version control | Auto-versioning, draft and published, with an automatic review log | SharePoint version history, with check-in and check-out |
| Requirements traceability | Database-backed TraceIDs, a live trace matrix, a visual Document Map and broken-trace detection | Cross-references kept by hand, and a matrix maintained in a spreadsheet |
| Project phase view | Design Phase board (Team and above): documents laid out by phase and work stream, with placeholders, owners and phase gates | Folder structure, built by hand |
| Training required | Little: a familiar document editor, with in-app help | Little: familiar to most people |
| Setup and IT involvement | Self-serve in the browser, no IT involvement | SharePoint sites, libraries and permissions set up by IT |
| Reviewer and auditor seats | Free | Each person needs a Microsoft 365 licence |
| Starting price | Free for one author, then US$35/mo per author (Essentials) or US$64/mo per author for a team (Team) | Included with Microsoft 365, with e-signatures licensed separately |
| Onboarding | Import your existing DOCX in minutes | Already have it |
| Deployment | Cloud, nothing to install | Microsoft 365 cloud, or SharePoint Server on-premises |
Comparison based on publicly available information as of 2026 and may change. Verify current details with each vendor.
Common questions
Can I replace Word and SharePoint for design documents?
Yes, for your controlled design documents. Traceable is a document editor, a versioned store, a review and e-signature workflow and a traceability tool in one place, so the documents a design history file depends on no longer live across Word, SharePoint, a signature tool and a spreadsheet. Keep Microsoft 365 for everything else.
Will my team have to learn a new way of writing?
Very little. Traceable edits documents the way Word does, with headings, tables, images and page layout, and adds requirement rows with IDs where you need traceability.
Can I bring my existing Word documents across?
Yes. Traceable imports DOCX, XLSX and Markdown, so you can start from the documents you already have and add trace links as you go.
Do I still need a separate e-signature tool?
No. Review and approval with e-signatures is built in, with FDA 21 CFR Part 11 compliant e-signatures on the Regulated plan, and every signature is recorded in the audit trail of the document it signs.
What does it cost?
Traceable is free for one author, then starts at US$35 per author per month. Reviewers and auditors are free, so the people who only read and sign do not need a seat.
Bring your Word documents across
Import your DOCX files and see live traceability in minutes.