Clinical-grade traceability without clinical-grade pain.
21 CFR Part 11, CLIA, and CAP-aligned workflows on a workspace your scientists actually want to use. The compliance is built into the data model, not bolted on through a separate audit tool.
What slows your lab down today
The familiar pains.
Regulatory burden
21 CFR Part 11 and CLIA documentation expectations grow every year. The legacy LIMS was built before most of them existed.
Variant review bottlenecks
Two-reviewer sign-off lives in spreadsheets and email. Discrepancies surface at the worst possible moment.
Reporting overhead
Each report assembles by hand from three systems. Every template change cascades through every prior report.
Patient-data handling
PHI lives in records that don't enforce role-based access. Every export is a compliance question.
How Labitron helps
The pieces, configured for clinical work.
21 CFR Part 11 e-signatures
Identity capture, password re-confirmation, reason-for-signature, time-stamp — built into the workflow, not after-the-fact metadata.
Immutable audit trails
Every record is event-sourced. The history cannot be edited or hidden. CLIA / CAP inspections become a query, not an exercise.
Structured variant review
Two-reviewer workflows with explicit concordance / discordance handling. Discrepancy resolution is a first-class object, not a Slack thread.
Customizable report templates
Build once, generate every report from live data. Template changes are versioned and re-runnable. PDF + HL7 / FHIR export.
Get started
See Labitron for clinical and diagnostic labs.
Compliance walkthrough included. We'll show you the audit-trail model, the e-signature flow, and the variant-review template.