ISO 13485 & FDA-ready quality management. Full compliance at 1/10th the price of Greenlight Guru or MasterControl.
Track corrective and preventive actions from identification to closure. Automated workflows ensure nothing falls through the cracks during FDA audits.
Six integrated modules that cover the full QMS lifecycle — from CAPA to complaint handling.
End-to-end corrective and preventive action tracking. Initiation, investigation, root cause analysis, corrective action, and effectiveness verification.
Plan, schedule, and execute internal and external audits. Track findings, assign corrective actions, and generate audit reports for regulatory submissions.
Document and manage nonconforming materials, products, and processes. Automated routing to quality team with severity-based escalation rules.
Track employee training requirements, completions, and expirations. Automated reminders when certifications are due. Audit-ready training matrix.
Capture customer complaints with full traceability to product, lot, and unit. MDR/MedWatch integration for medical device adverse event reporting.
Manage approved supplier list, track supplier CAPAs, and monitor incoming inspection results. Supplier scorecards with quality metrics.
Full compliance at a fraction of the cost. No consultants, no 6-month implementation.
| Feature | Azora QMS | Greenlight Guru | MasterControl |
|---|---|---|---|
| CAPA Management | ✓ | ✓ | ✓ |
| Document Control | ✓ | ✓ | ✓ |
| Audit Management | ✓ | ✓ | ✓ |
| Training Records | ✓ | ✓ | ✓ |
| Complaint Handling | ✓ | ✓ | ✓ |
| Project Management | ✓ (with Dev Manager) | ✗ | ✗ |
| ERP / Procurement | ✓ (with Azora ERP) | ✗ | ✗ |
| HR / Team Management | ✓ (with Azora HR) | ✗ | ✗ |
| Setup Time | Days | Weeks | Months |
| Price (per user/mo) | $22 | $250+ | $200+ |
Azora QMS gives you everything you need for ISO 13485 and FDA compliance.
or $18/user/mo billed annually
Or get Azora QMS + 7 other products for $49/user/mo with the Platform Bundle
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