Cloud-based validation software for clinical laboratories. Run CLIA-compliant studies, generate audit-ready reports, and manage your entire QA workflow — from any device.
ValidToolsLab isn't a single tool — it's three systems your lab would otherwise need to buy separately, working together under one login.
35+ CLIA/CAP-compliant modules — Precision, Accuracy, Linearity, Method Comparison, Interference, Carryover, Molecular, Blood Bank, and more.
The Core Validation EngineDaily/weekly/monthly instrument maintenance per manufacturer specs, reagent lot inventory, expiration alerts, and lot-change verification tracking.
Day-to-Day OperationsDocument control (SOPs), CAPA tracking, inspection findings, staff credentials, competency assessment, PT/EQA tracking, staff scheduling, and Six Sigma benchmarking.
Full Compliance Coverage✓ All three systems included in every plan — no add-ons, no upsells, no separate logins.
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.
Within/between-run SD & CV · 95% CI for SD · Tukey outliers · Precision Goal Chart · Run Chart.
R² · SEE · SD & CV per level · %Recovery · TEa cone · Non-linearity test.
SEE · 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.
Mean baseline vs contaminated post-high samples · Statistical significance.
Multi-parameter hematology carryover · SD of lows · t-test.
Deming 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.
Pearson matrix · Deming per pair · Bland-Altman · Tukey · TEa goals · σ Sigma.
TE = |Bias| + 1.65×CV vs TEa · Six Sigma per QC level · CLIA & BV tables auto-fill.
%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.
Dose-Response · Paired Difference · Hemolysis · Lipemia · Icterus · Critical threshold.
Z-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.
R² · SEE · %Recovery per step · Tukey outliers · TEa cone · Expiry prediction.
Multi-level calibration curve verification · Regression per level.
PPA · NPA · PPV · NPV (95% Wilson CI) · FPR/FNR · Cohen's Kappa · Matrix heatmap.
Reproducibility for Pos/Neg assays · % agreement with 95% CI.
Cross-contamination detection for PCR & rapid tests.
QualitativeReproducibility for graded scales (Neg/Trace/1+/2+/3+/4+) · 95% CI · Distribution chart.
Compare two methods on graded scales · Weighted kappa · 95% CI · Per-grade chart.
RPR, VDRL, ANA — dilution series comparison (±1 step).
Serology lot change: QC old/new vs reagent old/new. Quantitative & qualitative.
Extract 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.
ABO/Rh typing concordance · Antibody screen sensitivity · Patient-safety-critical.
AABB StandardsThese are actual reports generated by ValidToolsLab's calculation engine, using sample data — the exact PDF-ready format your director will see. Show them to your lab director before requesting access.
Precision evaluation — SD/CV, 95% confidence intervals, Six Sigma, digital signatures and director approval, fully formatted.
View Sample Report →Method/lot comparison — Deming regression, Bland-Altman, Six Sigma, and full inspection-ready documentation.
View Sample Report →Automatic Six Sigma calculation per QC level with a data-driven Westgard rule recommendation — exactly what your director needs to justify your QC design.
View Sample Report →Sample data only — not a real patient or laboratory result.
Download 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 or CAP validation requirements — without spending hours in Excel.
The most common reason a lab validation tool stalls before purchase is a security review. Here's exactly what your IT department will find when they look — before they even have to ask.
ValidToolsLab stores instrument QC readings, reagent lots, and validation statistics — never patient results, MRNs, or other Protected Health Information. Most HIPAA-scoped reviews can be simplified accordingly.
Every connection runs over HTTPS/TLS. Data lives in a managed PostgreSQL database with encryption at rest and automated backups — no data is ever stored on a local machine.
Staff only see what their role and department allow. Access defaults to deny — a user with no assignment sees nothing until an admin explicitly grants it.
Every login, edit, approval, and signature is logged with user, timestamp, and IP address in a hash-chained record built to surface tampering — ready for a CAP or CLIA inspector.
Every validation report requires an analyst signature and a director sign-off before it's finalized — a documented chain of accountability for every result.
Each lab's data is logically separated from every other company on the platform. There is no shared visibility across organizations.
Have a security questionnaire, or want to walk your IT team through our architecture? Email sales@validtoolslab.com — we're happy to schedule a call.
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 | ✅ | ⚠️ 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 all 3 systems — Validation, Equipment/Reagent Management & Quality Suite · Annual billing · Cancel anytime
ValidToolsLab Concierge — send us your data, and a licensed Medical Laboratory Technologist runs the study and sends back a signed, director-ready report. No software to learn.
Request Concierge Service →Contact us for pricing — quoted same day.