REGULATORY COMPLIANCE

Achieve and demonstrate laboratory excellence

Labbit supports your pursuit of FDA, CAP, and CLIA compliance with capabilities that protect quality and preserve sample histories in immutable records.

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Enforce your exact assay and quality management procedures

Ensure laboratory processes are always executed according to compliant standards with system guardrails like required steps and information, rigorous role-based access controls, support for complex QC workflows, and automated flagging of inconsistencies.

Experience effortless laboratory audits with full transparency

Easily demonstrate regulatory compliance with comprehensive, immutable audit trail functionality. Quickly drill into detailed, visual sample histories to investigate and produce evidence of reproducibility and proper handling of non-conformance events.

Easily meet regulatory requirements for diagnostic reporting

Simplify one aspect of compliance with a 21 CFR Part 11 regulated system that lets you natively build customized reports with e-signatures and streamline batch sign-out to enable efficient auto-release and easy access to reports when needed.

Quickly adapt processes in response to regulatory changes

Feel confident that you can rapidly iterate laboratory workflows if and when regulations shift, without a massive resource investment. Labbit was designed with flexibility in mind, allowing users to easily reconfigure and deploy new processes while documenting changes to the assay life cycle for full traceability.

Feature Highlights

Configurable workbooks

Build SOPs that outline steps in concise, familiar terms with required fields and checkboxes to ensure adherence.

Access controls

Assign permissions based on user role and certifications to ensure only qualified technicians can work on certain assays.

QC workflows

Implement complex quality management workflows that automatically identify, track, and flag non-conformance events.

Immutable audit trails

Capture everything that happens across samples and assay life cycles in visual, permanent, traceable records.

Tailored reports

Automatically generate diagnostic reports with e-signatures that present all information required by regulating bodies.

HIPAA compliant

Feel confident that personally identifiable information is handled appropriately and according to HIPAA standards.