CLIA-Compliant Test Development and QC Documentation
Method validation, proficiency testing, quality control tracking, and accreditation readiness — all in one platform built for clinical and reference laboratories.
What Diagnostic Labs Deal With Every Day
CLIA & CAP Documentation Burden
Proficiency testing, quality control, method validation, and personnel competency — every aspect of diagnostic lab operations requires meticulous documentation.
Method Validation Complexity
Validating new tests requires extensive documentation of precision, accuracy, linearity, sensitivity, and specificity. Paper-based validation packets are error-prone.
QC Tracking Across Tests
Levey-Jennings charts, Westgard rules, and trending data across dozens of assays. Manual tracking means delayed detection of shifts and trends.
Accreditation Readiness
CAP and state inspections happen on schedule — and sometimes unannounced. Your documentation must be inspection-ready at all times.
Built for Diagnostic Lab Workflows
Method Validation Documentation
Structured templates for complete method validation — precision, accuracy, linearity, reportable range, reference intervals, and comparison studies. Every parameter documented, every calculation traceable.
- Pre-built validation protocol templates
- Structured data capture for precision and accuracy studies
- Linearity and reportable range documentation
- Comparison method and reference interval studies
QC Management & Analytics
Automated Levey-Jennings charts, Westgard rule evaluation, and trend analysis across all your assays. Detect shifts and trends before they become out-of-control events.
- Automated Levey-Jennings chart generation
- Westgard rule evaluation with instant alerts
- Multi-rule QC with configurable parameters
- Trend analysis across instruments and reagent lots
CLIA & CAP Compliance
Built-in workflows for CLIA compliance — personnel competency, proficiency testing, QC documentation, and instrument maintenance. Always inspection-ready.
- Personnel competency assessment tracking
- Proficiency testing result documentation
- Instrument maintenance and calibration logs
- Quality indicator tracking and reporting
Analyzer Integration
Connect clinical analyzers, molecular instruments, and point-of-care devices directly to the ELN Suite. Results flow automatically into structured quality records.
- Direct connectivity with clinical analyzers
- Automated result import and QC evaluation
- Middleware integration for result routing
- Instrument comparison and correlation studies
Accreditation Audit Packages
Generate complete documentation packages for CAP, CLIA, and state inspections in one click. Audit trails, QC records, validation summaries, and competency records — all organized and ready.
- One-click accreditation documentation packages
- Organized by CAP checklist section
- Electronic signatures with 21 CFR Part 11 compliance
- Version-controlled SOPs with review tracking
Regulations We Cover
Not generic “we support compliance” — specific, deep regulatory coverage.
CLIA '88
Clinical Laboratory Improvement Amendments requirements for test quality and laboratory standards
CAP Accreditation
College of American Pathologists laboratory accreditation checklist requirements
FDA 21 CFR Part 11
Electronic records and signatures for diagnostic device and LDT documentation
ISO 15189
Medical laboratory quality and competence requirements
HIPAA
Health Insurance Portability and Accountability Act data protection requirements
State Regulations
State-specific clinical laboratory licensure and documentation requirements
See How ELN Suite Fits Your Diagnostic Lab
Schedule a demo tailored to diagnostic workflows — method validation, QC tracking, and accreditation readiness.
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