Ingest. Map. Deliver.
From the documents you already have — your own QMS, or a supplier's — to a clause-by-clause audit trail in about 30 minutes. No QMS migration, no retraining, no consultant hours.
Connect your evidence.
Drop PDFs and Word docs — or connect Google Drive. Whether it's your own QMS or a supplier's you're auditing, documents are parsed page-by-page and indexed against the requirement structure of every standard you've licensed.
- Native parsers for PDF and Word — born-digital or exported
- Google Drive connector — drag and drop for everything else
- Page-accurate retrieval — every citation links back to source
- Text-layer documents read natively · scanned files flagged at upload, never silently skipped
Match every clause to your evidence.
An LLM auditor reads the requirement text of every clause in your standard, then finds the paragraphs in your documents that are claimed to satisfy it — or flags that nothing was found. The mapping is reasoned, not pattern-matched.
- 2,157 clauses indexed across 9 supported standards
- FDA QMSR incorporates ISO 13485 — one analysis covers both
- Every mapping shows the model's reasoning + the exact paragraph cited
- Confirm, dismiss, or reclassify any finding — the mapping is yours to edit
STANDARD CLAUSES
YOUR DOCUMENTS
An audit trail you can hand to anyone.
Every clause gets a verdict — compliant, observation, or nonconformity — with the exact paragraph from your documents cited. Page number, paragraph reference, full quote. The traceability your registrar will run if they don't see it from you first — and the same trail works for your boss, a customer's auditor, or your own file.
- Excel + PDF export — formatted exactly the way auditors expect
- Per-standard dashboards · Major/Minor NCs · OFIs separately classified
- Marked-up PDF export — findings highlighted in the source document itself
- Re-run as documents change — unchanged documents are never re-billed
A clause-by-clause audit, in less time than your last status meeting.
No upload to a vendor's eQMS. No 12-week onboarding. No restructuring of how your team works.
One run
A six-document audit completes in under five minutes; a full QMS takes about 30. Re-run anytime — unchanged documents are never re-billed.
Records verified
CAPA and NCR records are checked line-by-line against the SOPs that govern them — every record, not a sample.
Audit-ready
Excel + PDF exports formatted the way auditors read them. Page-precise citations. No re-typing.
Run an audit in 30 minutes.
Bring your own documents if you're ready, or watch a live audit run on a published example QMS we maintain.
Book a 30-min demo →