REGULATORY QMSR replaces 21 CFR Part 820 — is your quality system ready? Check your gaps free →
Solution

One Tool for Gap Assessments, Internal Audits, and Audit Prep

Upload your QMS documents — or your supplier's — and get clause-by-clause compliance findings with evidence citations. Run it on-demand, on a schedule, or the week before your auditor arrives.

Choose how you use it

On Demand

Gap Assessment

Run a one-time compliance analysis against any standard. Upload documents, get a clause-by-clause report with evidence citations. Use for baseline assessments, supplier qualification, or post-remediation verification.

On a Schedule

Internal Audit

Replace or supplement your annual audit cycle. Run against each department's documentation on a rolling schedule. Same criteria, comparable results across sites and time periods.

Before the Auditor

Audit Preparation

Upload your entire QMS 4-6 weeks before certification. Get a readiness score per clause so your team focuses on what matters most. Know what the auditor will find.

Not keyword matching. Real document comprehension.

1
Upload your documents — SOPs, manuals, records
2
AI reads full text, maps against clause requirements
3
Gaps identified with exact page and paragraph citations

Three workflows, one underlying problem

Consultants charge $5K-$15K per assessment

A single gap assessment costs thousands and takes weeks to schedule. Internal audits require qualified auditors. Audit prep consumes 2-4 weeks of your quality team's time.

Results depend on who's doing the work

Different auditors check different things. Internal audit findings from one site can't be compared to another. Without a consistent approach, you're measuring noise.

Supplier assessments don't scale

You need to verify 20, 50, or 100 suppliers' QMS documentation. Manual review means your quality team is buried in paper instead of improving your own systems.

You don't know what you don't know

The worst audit findings are the ones you didn't expect. Manual preparation misses subtle gaps — a clause partially addressed, evidence that exists but isn't linked.

What makes this different from a spreadsheet

Evidence-linked findings

Every gap links to the exact page and paragraph in your source documents. Click any finding to see highlighted evidence in the built-in PDF viewer. No vague references — every claim is verifiable.

Consistent methodology

Every assessment uses the same clause-by-clause analysis. Compare results across sites, suppliers, and time periods with confidence.

Re-run after fixes

After closing gaps, re-run the analysis. Verify corrective actions actually addressed the findings — objective evidence, not just sign-off.

Audit-ready exports

Export to Excel or PDF with full evidence citations. Hand your auditor a report they can verify themselves.

Standards: ISO 13485 FDA QMSR AS9100D ISO 9001 EU MDR

Ready to run your first assessment?

Start your 14-day trial. Upload documents and get clause-by-clause results in minutes.

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