Document control that’s audit-ready on day one.
Revisions, approvals, and electronic signatures in one controlled system — shipped with ~60 pre-written procedures and a dedicated rep who sets it up with you. So the current version is always the one everyone’s using, and audit prep stops being a scramble.
ISO 9001 · 13485 · IATF 16949 · 17025 · FDA 21 CFR Part 11
Spreadsheets and shared folders don’t survive an audit.
“Which one is current?”
Copies live in email, desktops, and three folders. Nobody’s sure which revision is the released one — and neither is your auditor.
Approvals you can’t prove
A signature on paper, or none at all. When the auditor asks who approved Rev C and when, the trail goes cold.
Audit prep is a fire drill
Every audit means days of hunting for the right versions, sign-offs, and training records instead of running the business.
One controlled source of truth — everyone always sees the released version.
Revision control
Every change is a tracked revision with full history. The current release is unmistakable; superseded versions are locked away, not floating around.
Review, approve, e-sign
Route documents for review and approval with electronic signatures that satisfy 21 CFR Part 11 — every sign-off stamped with who and when.
~60 procedures included
Start from a working, interlinked QMS instead of a blank page. Add your logo, review, and release — you’re most of the way there on day one.
Find it fast, read-only
Staff open the current release in the built-in viewer — no editing, no stray copies. Link documents to processes, records, and training.
Built-in audit trail
Every create, change, approval, and read is logged. When the auditor asks, the answer is one click away — not a week of digging.
Claude Review
Claude reads any document against the exact ISO clauses that govern it and flags the gaps — a pre-audit read on demand. See below ↓
Claude finds the gaps — and fixes them.
Click Review on any controlled document and Claude reads it against the specific clauses it’s linked to — returning each gap, its severity, and the fix, with a citation to the exact released revision.
It’s the compliance officer’s pre-audit read, available on demand — and it runs on your own server, so your documents never leave it.
See a live review →Gap: no explicit statement of when external parties participate in the design process.
Documents that have survived the toughest audits.
See your documents under control.
In a 30-minute demo we’ll show revision control, e-signatures, the ~60 included procedures, and a live Claude Review — with the rep who’d set it up.
Request a Demo →One of our friendly account reps will be assigned to your account and can walk you through it · No credit card