Cloud-based validation software for clinical laboratories. Run CLIA-compliant studies, generate audit-ready reports, and manage your entire QA workflow — from any device.
Every quantitative module automatically calculates your method's Six Sigma performance using your TEa (Total Allowable Error) from CLIA 2024 or Biological Variation tables — no extra steps required.
Deming & Passing-Bablok regression · Bland-Altman · Tukey outliers · TEa cone · σ Sigma.
CLSI EP09-A3Within/between-run SD & CV · 95% CI for SD · Tukey outliers · Precision Goal Chart · Run Chart.
CLSI EP05-A3R² · SEE · SD & CV per level · %Recovery · TEa cone · Non-linearity test.
CLSI EP06-ASEE · SD per level · 95% CI for bias · Tukey outliers · TEa proximity cone.
CLIA §493.1255C% · SD of lows · t-test significance · Sequence plot with ±2SD bands.
Broughton / EP47Mean baseline vs contaminated post-high samples · Statistical significance.
CLSI EP47Multi-parameter hematology carryover · SD of lows · t-test.
CLSI H26-A2Deming regression · Bland-Altman · Tukey · 95% CI for bias · TEa goals · σ Sigma.
CLIA §493.1256Drift % per timepoint · Linear trend analysis · SD of drift · Expiry prediction.
CLSI EP25-APearson matrix · Deming per pair · Bland-Altman · Tukey · TEa goals · σ Sigma.
CLSI EP09-A3TE = |Bias| + 1.65×CV vs TEa · Six Sigma per QC level · CLIA & BV tables auto-fill.
CLSI C24-A4%Bias vs known value · 95% CI · %Recovery · TEa/SEa · Six Sigma · PT/EQA/CRM/NIST.
CLIA §493.1253Commutability · 95% Prediction Interval · Deming · QC material validation vs native patient samples.
CLSI EP14-A3Dose-Response (EP07 §6) · Paired Difference (EP07 §7) · Hemolysis · Lipemia · Icterus · Critical threshold.
CLSI EP07-A3Z-score across 20+ instruments · Drift detection · Run chart · Heatmap · Monthly comparison.
CLIA §493.1256% outside proposed RI · D'Agostino normality test · 90% CI for RI limits · Histogram.
CLSI EP28-A3cR² · SEE · %Recovery per step · Tukey outliers · TEa cone · Expiry prediction.
CLSI EP34-AMulti-level calibration curve verification · Regression per level.
CLSI EP06PPA · NPA · PPV · NPV (95% Wilson CI) · FPR/FNR · Cohen's Kappa · Matrix heatmap.
CLSI EP12-A2Reproducibility for Pos/Neg assays · % agreement with 95% CI.
CLSI EP12Cross-contamination detection for PCR & rapid tests.
QualitativeReproducibility for graded scales (Neg/Trace/1+/2+/3+/4+) · 95% CI · Distribution chart.
CLSI EP15Compare two methods on graded scales · Weighted kappa · 95% CI · Per-grade chart.
CLSI EP26RPR, VDRL, ANA — dilution series comparison (±1 step).
CLSI EP26Serology lot change: QC old/new vs reagent old/new. Quantitative & qualitative.
CLSI EP26Extract tables from analyzer reports automatically.
ToolPreview, remove columns, and download clean CSV files.
ToolCombine two CSV files — auto-maps columns, remap or skip any field.
ToolC₁V₁ = C₂V₂ · Serial dilution series · Linearity verification built-in.
Tool6 required CLIA elements per analyst/test · Due date tracking · Overdue alerts.
CLIA §493.1451Grade PT events · SDI calculation · Unsuccessful pattern detection across events.
CLIA §493.801-865Corrective/Preventive Action cases · Root cause · Effectiveness verification · Full lifecycle.
CAP GEN.20376Consolidate every study for an instrument into one inspection-ready package · Gap checklist.
ToolMonth-by-month Six Sigma trend by instrument, department, or analyte · Improving vs declining.
ToolLimit of Detection & Quantitation · Hit-rate analysis · Cross-reactivity panel.
CLSI EP17-A2ABO/Rh typing concordance · Antibody screen sensitivity · Patient-safety-critical.
AABB StandardsDownload our complete IQ/OQ/PQ validation package — includes a print-ready manual and 22 reference CSV templates designed for CLIA, CAP, and Joint Commission inspections.
ZIP file · 6.8 KB · No email required
Any clinical laboratory that needs to meet CLIA, CAP, or CLSI validation requirements — without spending hours in Excel.
The only cloud-based validation platform built specifically for clinical laboratories with a full director approval workflow and digital signatures.
| Feature | ValidToolsLab | Legacy Desktop Tools | Excel-Based Tools |
|---|---|---|---|
| Cloud-based — access from any device | ✅ | ❌ Windows only | ❌ Windows + Excel |
| Multi-user with role-based access | ✅ | ❌ Single user | ❌ Single user |
| Director approval workflow | ✅ | ❌ | ❌ |
| Digital signatures (analyst + director) | ✅ | ❌ | ❌ |
| Immutable audit trail | ✅ | ❌ | ❌ |
| Qualitative & semiquantitative modules | ✅ 6 modules | ⚠️ Limited | ⚠️ Limited |
| 3 carryover protocols (Broughton/EP47/H26) | ✅ | ⚠️ Partial | ❌ |
| Mobile app (iPhone & Android PWA) | ✅ | ❌ | ❌ |
| Email notifications on report submission | ✅ | ❌ | ❌ |
| Regulatory context page per module | ✅ | ❌ | ❌ |
| Instrument model management | ✅ | ❌ | ❌ |
| CSV upload + manual data entry | ✅ | ⚠️ Manual only | ⚠️ Copy-paste |
| 5-day free trial — no credit card | ✅ | ❌ Demo only | ⚠️ 14-day trial |
All plans include every module · Annual billing · Cancel anytime