Compliance · NATA / ISO 15189 / RCPA

Compliance-ready software for molecular genetics & pathology labs.

Automatic audit trails, version-controlled SOPs, role-based access and in-country hosting — aligned with the NATA, ISO 15189 and RCPA requirements Australian labs are assessed against.

The honest version

No software is "NATA certified" — NATA accredits laboratories, not products. What compliance-ready software does is give your lab the controls and evidence it relies on during assessment: a complete, automatic record of who did what and when, controlled by role, retained securely.

CassianLab was built inside a NATA-accredited molecular genetics lab, so those controls are designed in — not bolted on to pass an audit.

What assessors look for

The controls that make a lab audit-ready

Automatic, immutable audit trails

Every status change, classification decision, upload and sign-out is logged automatically with user, timestamp and prior value — the evidence NATA and ISO 15189 assessors ask for, without manual reconstruction.

Version-controlled SOPs & workflows

Workflow states and documented procedures are versioned, so you can show exactly which process was in force when a case was handled.

Role-based access control

Six-tier permissions with per-module access, so scientists, curators, senior scientists and directors see and change only what their role allows.

Data residency & isolation

Each lab runs on its own isolated instance. Australian lab data can be hosted in Australia, with AES-256 encryption at rest and in transit and daily backups.

Traceable variant sign-out

Multi-tier review (Curator 1, Curator 2, senior sign-out) is enforced and recorded, giving a defensible chain for every reported result.

Quality & QC tracking

Coverage/QC thresholds, rogue-status detection and cross-module data-integrity checks surface problems before an audit does.

See the audit trail in your lab's context.

We'll walk your quality manager through exactly what is logged, how records are retained, and how it maps to your NATA / ISO 15189 documentation.

FAQ

NATA, ISO 15189 & RCPA: common questions

What does NATA / ISO 15189 require from molecular pathology lab software?

For medical laboratory accreditation under ISO 15189 (assessed by NATA in Australia), the software a lab uses must support traceability, data integrity and control of records: automatic audit trails of who did what and when, controlled access by role, version control over procedures, secure retention and backup of records, and a defensible chain from result to sign-out. The software does not grant accreditation — it provides the evidence and controls the lab relies on during assessment.

Is CassianLab NATA certified or ISO 15189 certified?

No — and no software product is. NATA accredits laboratories, not software, and ISO 15189 is a laboratory accreditation standard. What CassianLab provides is software that is aligned with those requirements: automatic audit trails, role-based access, version-controlled workflows and in-country data hosting that support your lab's own NATA / ISO 15189 accreditation and surveillance. We built it inside a NATA-accredited molecular genetics lab, so it reflects what assessors actually look for.

How does software help with the RCPA Quality Assurance Programs?

RCPA QAP participation generates external quality-assurance results a lab has to track, act on and evidence over time. A workflow system helps by keeping QC and proficiency data alongside the cases it relates to, flagging out-of-range results, and retaining the record of what was reviewed and by whom — so the QAP story is traceable rather than reconstructed from spreadsheets and email.

Is Australian molecular genetics lab data hosted in Australia?

It can be. Each CassianLab deployment is an isolated instance, and for Australian labs the database and application can be hosted in-country, with encryption at rest and in transit, daily automated backups and complete access logging. Data residency and ownership terms are set per deployment.