Validation &verification

Plan studies, analyze with CLSI-based engines, and sign inspection-ready reports — powered by AI tools built for the lab.

  • Study plans
  • CLSI analysis
  • Signed reports
  • AI workflows
  • Study plans that match your lab

    Configure verification and validation plans tied to your analyzers and analytes — ready for the work ahead.

  • CLSI-based analysis you can defend

    Precision, linearity, method comparison, and more — grounded in published practice, not improvised AI math.

  • Signed reports in one click

    Generate branded, signable reports with an audit trail so evidence is ready when surveyors ask.

  • AI that works the workflow

    Drop in data, extract measurements, draft insights, and move into SOPs or training when a study demands follow-through.

Calibration verification and linearity results with AI assistant explaining pass and fail outcomes

Defend every study with CLSI-based evidence

Legion Diagnostics runs pathologist-built statistics, keeps signed reports and audit trails together, and links findings into documents, training, or quality work when the study requires it.

Regulatory requirements

Built around the standards labs cite for verification and validation:

  • CLIA: 42 CFR 493.1253
  • CLSI: EP05 / EP06 / EP09
  • CAP: COM.40000

From study plan to signed report

Replace fragmented spreadsheets and desktop stats packages with one workflow from plan through signed report. Statistical analysis stays in pathologist-built engines; AI accelerates extraction, documentation, and next steps.

Configure verification and validation plans tied to your analyzers and analytes — ready for the work ahead.

  • Drop in your data
  • Analyze with confidence
  • Sign and report

  1. 1Drop in your data
  2. 2Analyze with confidence
  3. 3Sign and report
  4. 4Link follow-up work

Elevating laboratory excellence