Aligntra by the numbers
Who It's For
Trusted by quality teams across medical devices, aerospace, and manufacturing
Whether you're a consultant, manufacturer, enterprise team, or regulatory body, Aligntra adapts to your workflow.
Run gap assessments across multiple clients and standards from one dashboard. Upload a document set, get clause-by-clause findings with evidence citations, and export audit-ready reports — in an afternoon instead of a week.
Learn more →Enterprise-grade compliance analysis without a dedicated QA team. Upload your SOPs and records, get gap detection across every applicable clause, and know exactly where you stand before your next audit.
Learn more →Consistent clause-by-clause analysis across every facility and site. Same criteria, same evidence standards, same report format — whether you have 2 locations or 20.
Learn more →Structured, evidence-linked reports that map directly to clause requirements. Every finding traces to the exact page and paragraph — document review focuses on verification, not searching.
Learn more →Key Features
Every finding links to the exact page and paragraph.
Automated compliance verification built for supply chain quality teams.
Evidence Traceability
Every finding includes exact page and paragraph citations. Click any evidence item and the source PDF opens with the passage highlighted. Nothing is a black box.
Multi-Standard
ISO 13485, AS9100D, FDA QMSR, ISO 9001, EU MDR, MDSAP. Switch instantly.
Audit-Ready Reports
Export to Excel or PDF with full evidence citations. Hand your auditor a report they can verify themselves.
Full QMS Audit
Upload your entire document set and get a system-level readiness report — every clause mapped, every gap cited, audit-ready summary in one pass. 10 documents analyzed in under 5 minutes.
See It In Action
Built for real compliance workflows
From standard coverage tracking to evidence-linked PDF highlighting — see how Aligntra gives you audit-ready visibility.
Track compliance across every clause
Upload your QMS documents and see exactly where you stand against ISO 13485, AS9100D, FDA QMSR, or any supported standard. Color-coded progress bars show coverage at a glance.
- Section-by-section progress tracking
- Issues prioritized by severity
- Real-time compliance score
Every finding backed by evidence
Drill into any clause to see the AI-generated analysis summary, evidence items with exact page citations, and identified compliance gaps — all in one view.
- Clause-by-clause navigation sidebar
- AI analysis summary with gap identification
- Clickable evidence with page references
See exactly where evidence lives
Click any evidence item and the original PDF opens with the relevant passage highlighted. No more hunting through 50-page documents to verify findings.
- Highlighted passages in the source PDF
- Navigate between evidence locations
- Verify AI findings yourself in seconds
The Difference
Manual Audit Prep Takes Weeks. Aligntra Takes Minutes.
The Challenge
$2,500+ per supplier audit in external auditor fees. Weeks of waiting for reports that may not even be thorough.
With Aligntra
80% cost reduction. Upload supplier documents and get clause-by-clause findings in minutes, not weeks.
The Challenge
Inconsistent evaluation — different auditors check different things. Results depend on who's reviewing, not what's in the documents.
With Aligntra
100% consistent methodology. Every analysis uses the same clause-by-clause criteria, every time, across every supplier.
The Challenge
Limited visibility into supplier documentation. Supplier QMS documents pile up unreviewed because there's no bandwidth for manual review.
With Aligntra
Full evidence traceability. Every finding links to the exact page and paragraph. Verify anything yourself in the built-in PDF viewer.
Supported Standards
ISO 13485, FDA QMSR, AS9100D & More
Verify compliance against major industry standards. Full clause-by-clause analysis with evidence traceability.
ISO 13485:2016
Quality management systems for medical device design, production, installation, and servicing.
FDA QMSR
Quality Management System Regulation (21 CFR Part 820) harmonized with ISO 13485.
AS9100D
Quality management for aviation, space, and defense industries with risk management.
ISO 9001:2015
International quality management standard applicable to any organization or industry.
EU MDR 2017/745
European Medical Device Regulation including Annex I and technical documentation.
MDSAP
Single audit program covering US, Canada, Australia, Brazil, and Japan requirements.
View all supported standards →
Need a standard we don't support yet? Contact us to discuss your requirements.
Transparent Pricing
Pricing for Every Audit Volume
Start free or select a plan based on your audit volume and regulatory requirements.
Why subscription pricing? A single manual compliance review costs $2,500+ in loaded labor. One subscription month lets you review your entire QMS, all your suppliers, and run unlimited re-checks—for less than a single manual review. Calculate your savings →
14-Day Trial
Full access to try Aligntra risk-free for 14 days. No commitment — cancel anytime.
- 15 analyses
- 1 Full QMS Audit (up to 5 docs)
- AI-powered document classification
- 1 regulatory standard
Professional
Run up to 2 full compliance audits per month with evidence traced to exact page and paragraph.
- 60 analyses per month
- 1 regulatory standard (+$199/standard • all standards with Business)
- Evidence traceability + PDF highlighting
- Priority email support (24hr response)
- 1 user seat
Business
Run up to 5 full compliance audits monthly with record-level verification and multi-standard coverage.
- 150 analyses per month
- All standards — ISO 13485, FDA QMSR, AS9100D, ISO 9001 & more
- SOP-to-record compliance verification
- White-label reports with your branding
- 5 users + 10 viewers (+$99/seat)
- Priority support + live chat
Enterprise
For large companies, notified bodies, and complex multi-standard compliance requirements.
- Unlimited analyses across all standards
- Custom standards & frameworks
- SSO/SAML & API access
- SLA guarantee & dedicated CSM
- Custom onboarding, training & data residency
- Audit trail & compliance logging
Need gap remediation, not just gap identification? Platform + Consulting bundles →
Questions & Answers
Frequently asked questions
Everything you need to know about Aligntra compliance automation.
Most customers start with supplier audits (qualifying new vendors, conducting periodic reviews, reducing outsourced audit costs) and expand to full internal audits as they scale toward certification.
Compliance, Confirmed.
Ready to cut your audit costs by 80%?
Start your 14-day trial. Review your documents in minutes. See the difference.