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

Enterprise-Grade Compliance Without the Enterprise Budget

You don't need a dedicated QA department or a six-figure consulting contract to meet your compliance requirements. Upload your QMS documents and get clause-by-clause gap findings with evidence citations — in minutes, not weeks.

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The Reality

Your next audit will find gaps you don't know about yet

You're the QA department

You also manage production, handle supplier issues, and respond to customer complaints. There's no time for clause-by-clause document review — you're running an operation, not a compliance department.

Your documentation grew organically

SOPs written by different people at different times. A quality manual that hasn't been fully reviewed since the last audit. Work instructions that reference superseded procedures. You know there are gaps — you just don't know where.

Consultants are expensive and slow

A single gap assessment runs $5K-15K and takes 2-4 weeks. By the time the report arrives, you've lost half your remediation window. And you need another assessment after every major CAPA.

The auditor will find what you missed

One major nonconformity can delay certification by months. One observation cascades into a corrective action that pulls your team off production. The cost of a finding at audit is 10x the cost of finding it yourself.

How It Works

From anxiety to answers in three steps

Run your first compliance assessment before your next meeting.

1
Upload
Drop in your QMS documents
SOPs, quality manuals, work instructions, CAPA records, supplier documentation — any PDF or Word file. Drag and drop up to 30 documents at once.
2
Analyze
AI maps every clause to your evidence
Full-text comprehension against ISO 13485, AS9100D, ISO 9001, FDA QMSR, or EU MDR. Not keyword matching — real document understanding with page-and-paragraph citations.
3
Act
Fix gaps while there's still time
Prioritized findings ranked by severity. Each one links to the exact location in your documents. Export the full report to Excel or PDF — hand it directly to your auditor as evidence of preparation.
Standards: ISO 13485 FDA QMSR AS9100D ISO 9001 EU MDR ISO 14971
In Practice

Built for how lean quality teams actually work

Pre-certification readiness check

4-6 weeks before your ISO 13485 or AS9100D audit, upload your complete QMS package. Get a clause-by-clause report showing exactly where you stand. Focus your limited prep time on the gaps that matter — not reviewing every document from scratch.

Post-CAPA verification

After closing a corrective action, re-run the analysis on updated documents. Compare before-and-after to confirm the gap is closed. Demonstrate effectiveness with data, not assertions.

Supplier qualification

When a new supplier sends their quality manual, upload it and get a compliance report for your supplier file. When an existing supplier has a quality escape, re-run against their corrective action.

Management review evidence

Run a quarterly self-assessment and present the trend to leadership. Show which clauses improved, which regressed, and where to invest. Turn management review from a checkbox into a data-driven conversation.

The Math

One assessment replaces a $5K-15K consultant engagement

Traditional Consultant
$5K–$15K

Per assessment

  • × 2-4 weeks for results
  • × Schedule weeks in advance
  • × Pay again after every CAPA
Aligntra Professional
$749/mo

60 analyses per month

  • ✓ Results in minutes
  • ✓ Run anytime, no scheduling
  • ✓ Re-run after every fix

Your quality manager's time is worth more than document review. Aligntra handles the systematic analysis — your team focuses on fixing gaps and running production.

Find your gaps before the auditor does

Start your 14-day trial. Run your first assessment today — results in minutes.

Start Your Trial Book a Demo

14-day free trial · No credit card required · Cancel anytime