navisLIMS — end-to-end clinical LIMS for molecular diagnostics labs

navisLIMS is the end-to-end laboratory management platform for ambitious diagnostics startups. Purpose-built for CLIA/CAP environments, it combines proven laboratory practices, powerful self-service configuration, and extensive technical controls enabling HIPAA and Part 11 compliance.

  • CLIA
  • CAP
  • 21 CFR Part 11
  • HIPAA
  • NYSDOH CLEP

One end-to-end system, working on day one.

navisLIMS is complete on day one. It already knows what a molecular diagnostics lab needs — structured intake, parallel state machines for every sample, role-based sign-off mapped to CLIA — and configures to your tests and your workflow. So instead of building the plumbing, you run the lab.

Complete on day one

The whole workflow — accessioning, tracking, results, review, and signed reporting — in one system, from the very first sample.

Configured to your lab

Your test menu, sample states, CLIA roles, and identifier formats are configuration, not custom code — shaped to how you run, no development project required.

Compliance built in

Part 11 e-signatures, CLIA-mapped roles, and a tamper-evident audit log are on by default — the controls that survive inspection, not bolt-ons.

Built for the frameworks you live under

Compliance isn’t a feature you bolt on.

navisLIMS is purpose built for CLIA, CAP, HIPAA, and FDA 21 CFR Part 11. It will be the compliant system of record that helps you run to these standards. It doesn’t make your lab automatically inspection-ready, but it will enable your people and procedures do that in a system they can control.

  • 21 CFR Part 11
  • HIPAA
  • CLIA
  • CAP
  • NYSDOH CLEP

Get started

See your lab running on navisLIMS.

Book a 30-minute walkthrough and see it on a workflow like yours.