Automated clause-by-clause analysis
Upload your QMS documents and Aligntra maps every clause of your chosen standard to your documentation. See exactly which requirements are covered, partially addressed, or missing.
- Section-by-section progress with color-coded status
- Compliance score calculated from evidence quality
- Issues categorized by severity (Major, Minor, Opportunity)
Every finding backed by traceable evidence
Drill into any clause to see the AI-generated analysis summary, evidence items with exact page citations, and identified compliance gaps. Nothing is a black box.
- Navigate clauses with the sidebar, sorted by status
- AI explains what was found and what's missing
- Evidence citations link directly to source documents
See exactly where evidence lives in your documents
Click any evidence citation and the original PDF opens with the relevant passage highlighted. Verify AI findings yourself in seconds instead of searching through 50-page documents.
- Highlighted text passages in the source PDF
- Navigate between multiple evidence locations
- Built-in PDF viewer — no separate software needed
One platform, every standard you need
Analyze documents against ISO, FDA, EU, and aerospace standards. Switch between them instantly.
ISO 13485:2016
Medical device quality management systems
Full SupportISO 9001:2015
General quality management systems
Full SupportAS9100D
Aerospace quality management systems
Full SupportFDA QMSR
FDA Quality Management System Regulation
Full SupportMDSAP
Medical Device Single Audit Program
Full SupportISO 14971:2019
Medical device risk management
Full SupportEU MDR
European Medical Device Regulation
Full SupportEverything else you need
Audit-Ready Reports
Export to Excel or PDF with full evidence citations. Present to auditors or management with confidence.
Record Verification (RCV)
Verify filled records (CAPAs, NCRs, training logs) against their governing SOPs with evidence traceability.
Full QMS Audit
Upload your entire document set for holistic compliance analysis. See gaps, coverage, and audit readiness across all clauses.
Minutes, Not Weeks
Analysis completes in minutes. What takes external auditors 2-4 weeks happens before your first meeting.
Enterprise Security
AES-256 encryption at rest, TLS 1.3 in transit. Complete organization isolation. Your documents are never used for AI training.
Google Drive Integration
Import documents directly from Google Drive. No manual download and re-upload needed.
Ready to transform your compliance workflow?
Start your 14-day trial. Analyze documents in minutes.