Quality Management

Audit day should be boring.

CAPA, NCR, audits, complaints, risk, change control, and full traceability — in one database, so ISO 13485 evidence is a query, not a three-week scramble.

Built for medical-device and regulated hardware teams facing ISO 13485, 21 CFR 820, or MDSAP.

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QMS CAPA list with effectiveness checks linked to source NCRs and audit findings
Actual product interface · sample data
One platformShared operational data
Role-awareAccess follows responsibility
ConnectedContext follows the record

The problem

Audit prep is a fire drill because the evidence is scattered.

When quality records live in Word files, a shared drive, and three peoples' memories, every audit becomes an archaeology project.

  1. 01

    Evidence lives in a dozen places

    A CAPA in one folder, the NCR that triggered it in another, the audit finding in an email. Proving they connect is a manual chase.

  2. 02

    Traceability is a stale spreadsheet

    The requirement→spec→test→release matrix your auditor wants is maintained by hand and six months out of date the day you print it.

  3. 03

    Quality is one person babysitting the QMS

    Document control, training records, change signatures — all riding on a single quality engineer and the spreadsheet only they understand.

How Azora solves it

The evidence chain, generated from normal work.

Every CAPA links to the finding that triggered it; every test links to the spec it verifies. The audit pack assembles itself.

  1. 01

    CAPA & NCR

    Corrective/preventive actions and nonconformance reports with disposition workflow and effectiveness checks — auto-linked to the finding, complaint, or bug that triggered them.

  2. 02

    Traceability, generated

    Requirement → spec → test → release, built from links the team already makes. Click any node; the whole chain lights up.

  3. 03

    Risk register (ISO 14971)

    FMEA-style severity × probability × detectability scoring, linked straight to design controls.

  4. 04

    Change control with e-signatures

    Signed change control with intent attestation and an append-only record — built to support 21 CFR Part 11.

  5. 05

    Document & training control

    Versioned documents with approval workflow, read-receipts, periodic review, and per-employee training records.

  6. 06

    Audits & post-market

    Internal, supplier, and external audits; complaints and vigilance with the MDR clock; plus MDSAP cycle prep.

Practitioner perspective

The traceability matrix is generated from links the team already makes as part of normal work. Maintaining audit evidence stopped being a separate job.
NadiaRegulatory Lead at Azora Optical Solutions · the team that built Azora
1 DBCAPAs, NCRs, audits — one query
100%Findings traceable to source
0External tools for the audit pack

Connected by design

Quality Management does not become another silo.

Azora keeps project, quality, operations, people, clinical, and customer context on one operational data layer. Teams can follow the record instead of rebuilding its history in the next tool.

01

Capture the source

Keep the originating task, study, customer, unit, or people record attached to the work it creates.

02

Govern the handoff

Route ownership and approvals through role-aware workflows, with controlled history where the record requires it.

03

Read the same signal

Let downstream teams and leadership work from linked operational data instead of reconciling exports.

See the connected workflow

Make your next audit boring.

Explore the live demo, or request a seeded tenant — provisioned within 24 hours with sample CAPAs, NCRs, and a traceability graph to explore.

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