CLIA| CLSI| CAP| FDA 21 CFR Part 11

Laboratory Validation
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Cloud-based validation software for clinical laboratories. Run CLIA-compliant studies, generate audit-ready reports, and manage your entire QA workflow — from any device.

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22 Validation Modules — Quantitative, Qualitative & Semiquantitative
📈 Quantitative Modules
🔬

Method Comparison

Deming regression, Bland-Altman, systematic bias.

CLSI EP09
📊

Precision

%CV across days, runs, and replicates.

CLSI EP05
📐

Linearity / AMR

R² linear regression across the reportable range.

CLSI EP06
⚡

Carryover (Broughton)

High-to-low carryover % detection.

CLSI EP10
🧬

Carryover CLSI

Standard CLSI carryover protocol.

CLSI EP10
🩸

Carryover H26

Hematology multi-parameter carryover.

CLSI H26
📦

Lot-to-Lot

New vs old reagent lot bias and %CV.

CLSI EP26
⏱️

Stability

Reagent and sample stability over time.

CLSI EP25
🧪

Dilution Linearity

% Recovery across dilution series.

CLSI EP06
📐

Multipoint Calibration

Multi-level calibration curve verification.

CLSI EP06
✅

Calibration Verification

Linearity + precision + %bias combined (CLIA §493.1255).

CLIA / EP06
✅ Qualitative Modules
✅

Qualitative Correlation

Concordance %, Kappa, Se/Sp for Pos/Neg assays.

Qualitative
🧫

Qualitative Carryover

Cross-contamination detection for PCR & rapid tests.

Qualitative
🔁

Qualitative Precision

Reproducibility for Positive/Negative assays.

Qualitative
⚖️ Semiquantitative & Serology
⚖️

Semiquantitative Precision

Reproducibility for graded scales (Neg/Trace/1+/2+/3+/4+). Accepts ±1 grade.

CLSI EP15
📊

Semiquantitative Correlation

Compare two methods on graded scales — weighted kappa.

CLSI EP26
🔢

Titer Verification

RPR, VDRL, ANA — dilution series comparison (±1 step).

CLSI EP26
🔀

Cross Lot-to-Lot

Serology lot change: QC old/new vs reagent old/new. Quantitative & qualitative.

CLSI EP26
🛠️ Tools
📄

PDF → CSV Converter

Extract tables from analyzer reports automatically.

Tool
🧹

CSV Cleaner

Preview, remove columns, and download clean CSV files.

Tool
🔗

CSV Merger

Combine two CSV files — auto-maps columns, remap or skip any field.

Tool
🧪

Dilution Calculator

C₁V₁ = C₂V₂ and serial dilution calculator.

Tool
📦

Free Regulatory Validation Kit

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.

✓ IQ/OQ/PQ Manual (HTML → PDF) ✓ 22 Reference CSV Templates ✓ CLSI EP05, EP06, EP07, EP09, EP17 ✓ CLIA '88 & CAP Compliant ✓ 100% Free — No signup required
⬇️ Download Free Validation Kit

ZIP file · 6.8 KB · No email required

Why ValidToolsLab

Everything your lab needs — nothing it doesn't

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

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