๐ŸŽ‰ LIMITED OFFER: First 250 companies get a FREE 5-month Enterprise trial (15 users, all 13 modules) โ€” Claim yours now โ†’
CLIA| CLSI| CAP| FDA 21 CFR Part 11

Laboratory Validation
Made Simple

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

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21 Validation Modules โ€” Quantitative, Qualitative & Semiquantitative
๐Ÿ“ˆ Quantitative Modules
๐Ÿ”ฌ

Method Comparison

Deming regression, Bland-Altman, systematic bias.

CLSI EP09
๐Ÿ“Š

Precision

%CV across days, runs, and replicates.

CLSI EP05
๐Ÿ“

Linearity / AMR

Rยฒ linear regression across the reportable range.

CLSI EP06
โšก

Carryover (Broughton)

High-to-low carryover % detection.

CLSI EP10
๐Ÿงฌ

Carryover CLSI

Standard CLSI carryover protocol.

CLSI EP10
๐Ÿฉธ

Carryover H26

Hematology multi-parameter carryover.

CLSI H26
๐Ÿ“ฆ

Lot-to-Lot

New vs old reagent lot bias and %CV.

CLSI EP26
โฑ๏ธ

Stability

Reagent and sample stability over time.

CLSI EP25
๐Ÿงช

Dilution Linearity

% Recovery across dilution series.

CLSI EP06
๐Ÿ“

Multipoint Calibration

Multi-level calibration curve verification.

CLSI EP06
โœ…

Calibration Verification

Linearity + precision + %bias combined (CLIA ยง493.1255).

CLIA / EP06
โœ… Qualitative Modules
โœ…

Qualitative Correlation

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

Qualitative
๐Ÿงซ

Qualitative Carryover

Cross-contamination detection for PCR & rapid tests.

Qualitative
๐Ÿ”

Qualitative Precision

Reproducibility for Positive/Negative assays.

Qualitative
โš–๏ธ Semiquantitative & Serology
โš–๏ธ

Semiquantitative Precision

Reproducibility for graded scales (Neg/Trace/1+/2+/3+/4+). Accepts ยฑ1 grade.

CLSI EP15
๐Ÿ“Š

Semiquantitative Correlation

Compare two methods on graded scales โ€” weighted kappa.

CLSI EP26
๐Ÿ”ข

Titer Verification

RPR, VDRL, ANA โ€” dilution series comparison (ยฑ1 step).

CLSI EP26
๐Ÿ”€

Cross Lot-to-Lot

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

CLSI EP26
๐Ÿ› ๏ธ Tools
๐Ÿ“„

PDF โ†’ CSV Converter

Extract tables from analyzer reports automatically.

Tool
๐Ÿงน

CSV Cleaner

Preview, remove columns, and download clean CSV files.

Tool
๐Ÿงช

Dilution Calculator

Cโ‚Vโ‚ = Cโ‚‚Vโ‚‚ and serial dilution calculator.

Tool
๐Ÿ“ฆ

Free Regulatory Validation Kit

Download our complete IQ/OQ/PQ validation package โ€” includes a print-ready manual and 9 reference CSV templates designed for CLIA, CAP, and Joint Commission inspections.

โœ“ IQ/OQ/PQ Manual (HTML โ†’ PDF) โœ“ 13 Reference CSV Templates โœ“ CLSI EP05, EP06, EP07, EP09, EP17 โœ“ CLIA '88 & CAP Compliant โœ“ 100% Free โ€” No signup required
โฌ‡๏ธ Download Free Validation Kit

ZIP file ยท 6.8 KB ยท No email required

Choose your plan

All plans include full access to every validation module. Cancel anytime.

Starter
$200
per year ยท 2 users
  • All 13 validation modules
  • Unlimited reports
  • Digital signatures
  • Audit trail
  • 2 user accounts
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Enterprise
$1,500
per year ยท 15 users
  • All 13 validation modules
  • Unlimited reports
  • Digital signatures
  • Audit trail
  • 15 user accounts
  • Priority support
  • Onboarding session
Get Started