01
CAPA management
Corrective & preventive actions with effectiveness checks. Auto-link to source NCRs, complaints, audit findings.
Quality Management
ISO 13485-aligned evidence, ready to inspect.
CAPA, NCR, Change Control, Audits, Complaints, Risk Register, Design Reviews, Test Management, and Training. Signed change control and audit-oriented history connect evidence from requirement to release.
Read-only demo · no signup · realistic seeded records
What's in QMS
CAPA, NCR, change control — one database, not seven.
Most QMS tools are document repositories with a workflow bolted on. Azora's QMS lives in the same database as your tasks, units, and vendors — every CAPA links to the bug it traces, every audit finding links to the document it concerns.
02
NCR + Change Control
Nonconformance reports with disposition workflow. Change control with electronic signatures (designed for 21 CFR Part 11).
03
Document control
Versioned documents with approval workflow. Read-receipt tracking. Periodic review cadence.
04
Audit management
Internal + external audits. Finding tracking. Mock external audit prep for MDSAP cycles.
05
Risk register (ISO 14971-aligned)
FMEA-style risk analysis. Severity × probability × detectability scoring. Linked to design controls.
06
Traceability matrix
Every requirement → spec → test → release. Click any node, the whole chain lights up.
Connected workflow
Quality Management works better when the context travels with it.
Azora keeps project work, quality evidence, people, suppliers, units, documents, and customer context on one shared operating core—without a sync job between every team.
- 01CAPA management
Corrective & preventive actions with effectiveness checks. Auto-link to source NCRs, complaints, audit findings.
- 02NCR + Change Control
Nonconformance reports with disposition workflow. Change control with electronic signatures (designed for 21 CFR Part 11).
- 03Document control
Versioned documents with approval workflow. Read-receipt tracking. Periodic review cadence.
- 04Audit management
Internal + external audits. Finding tracking. Mock external audit prep for MDSAP cycles.
“The traceability matrix is generated from links the team already makes as part of normal work — requirement to spec to test to release. Maintaining audit evidence stopped being a separate job.”
1 DBCAPAs, NCRs, audits — one query
100%Audit findings traceable to source
0External tools required for audit pack
Open beta nowFree, demo-first, and sales-provisioned within 24 hours.
At GA: one plan, every module—$29/paid editor/month annually or $35 monthly, 30-day full-feature trial, unlimited free read-only viewers, and a 5-editor minimum. Open-beta design partners lock $20/editor/month annually for 24 months from GA.
See it before you talk to sales
See your QMS without the spreadsheets.
Explore the live demo, or request a tenant — provisioned with seeded CAPA, NCR, and audit data within 24 hours.