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

From Document Upload to
Audit-Ready Report in Minutes

Aligntra analyzes your QMS documents clause-by-clause against ISO 13485, FDA QMSR, AS9100D, and more — every finding linked to exact source evidence.

Start Your Trial Book a Demo

Three steps from document to decision

No integrations, no setup, no implementation — just upload, analyze, and act.

1

Upload Your Documents

Upload SOPs, records, manuals, or your entire QMS in bulk. Aligntra accepts PDF, Word, and Excel files.

Single documents or bulk batch
PDF, DOCX, XLSX supported
Google Drive import available
2

AI Analyzes Every Clause

Aligntra maps your document content to every clause of the selected standard and identifies gaps with exact evidence citations.

Clause-by-clause coverage mapping
Major NC, minor NC, observation classification
Single doc in ~5 min, full QMS in parallel
3

Review, Export & Act

Drill into any finding, verify evidence in the source PDF, export to Excel or PDF, and share with your team or supplier.

In-browser PDF viewer with highlights
Excel and PDF export with evidence citations
Shareable audit-ready reports

Manual Audit Prep Takes Weeks. Aligntra Takes Minutes.

See how Aligntra replaces manual, error-prone processes with intelligent automation.

Before

Manual Compliance Reviews

  • $2,500+ per supplier audit (external auditor fees)
  • 2–4 weeks waiting for supplier audit reports
  • Inconsistent evaluation across different suppliers
  • No visibility into which clauses are actually covered
VS
After

Aligntra Automation

  • 80% cost reduction vs outsourced supplier audits
  • Verify supplier QMS in minutes, not weeks
  • Consistent evaluation criteria across every supplier
  • Every gap cited to exact page and paragraph

Evidence-first by design

Every finding is traceable. You're never asked to trust a conclusion you can't verify.

Exact Page & Paragraph Citations

Every finding includes the specific location in your document where the evidence was found — or notably absent. No ambiguity about what was reviewed.

In-Browser PDF Highlighting

Click any evidence item and the source PDF opens with the relevant passage highlighted. Verify AI findings yourself in seconds without hunting through the document.

Major NC / Minor NC Classification

Gaps are classified by severity using ISO 19011 conventions — Major NC, Minor NC, Observation, OFI — so your team knows what to prioritize.

Ready to see it on your own documents?

Start your 14-day trial — 15 analyses included, no credit card required.