| Laboratory Name | | CLIA # | |
|---|
| Instrument / Analyzer | | Validation Date | |
|---|
| Software Version | ValidToolsLab™ v3.0 (13 Modules) | Document # | VTL-VAL-002 |
|---|
1. Installation Qualification (IQ)
Verifies that the system is installed correctly and accessible in a secure environment.
| Test ID | Procedure | Expected Criteria | Status |
|---|
| IQ-01 | Access portal via secure browser (HTTPS) | Login screen loads with SSL certificate | ☐ Pass ☐ Fail |
| IQ-02 | Verify role-based user access (Admin / Analyst / Director) | Each role restricted to authorized functions | ☐ Pass ☐ Fail |
| IQ-03 | Confirm data isolation between laboratory accounts | No cross-account data visibility | ☐ Pass ☐ Fail |
| IQ-04 | Verify audit trail activation | All user actions timestamped and logged | ☐ Pass ☐ Fail |
2. Operational Qualification (OQ) — Quantitative Modules
| # | Module | Reference File | Guideline | Key Acceptance Criterion | Status |
|---|
| 1 | Method Comparison | 01_method_comparison.csv | CLSI EP09-A3 | R² ≥ 0.990, Bias within limit | ☐ Pass ☐ Fail |
| 2 | Precision | 02_precision_ep05.csv | CLSI EP05-A3 | %CV ≤ 5.0% | ☐ Pass ☐ Fail |
| 3 | Linearity / AMR | 03_linearity_amr.csv | CLSI EP06-A | R² ≥ 0.990 | ☐ Pass ☐ Fail |
| 4 | Reference Intervals | 04_reference_intervals.csv | CLSI EP28 | 95th percentile within range | ☐ Pass ☐ Fail |
| 5 | Sensitivity / LoD | 05_sensitivity_ep17.csv | CLSI EP17 | LoD calculated from blank replicates | ☐ Pass ☐ Fail |
| 6 | Interference | 06_interference_ep07.csv | CLSI EP07-A2 | Bias ≤ allowable limit | ☐ Pass ☐ Fail |
| 7 | Carryover | 07_carryover.csv | Broughton / CLSI H26 | Carryover ≤ 1.0% | ☐ Pass ☐ Fail |
| 8 | Matrix Comparison | 08_matrix_comparison.csv | CLSI EP09 | Bias ≤ 5% | ☐ Pass ☐ Fail |
| 9 | Stability / Dilution / Multipoint | 13_stability_dilution_multipoint.csv | CLSI EP25, EP06 | % Change / Recovery within limit | ☐ Pass ☐ Fail |
3. Operational Qualification (OQ) — Qualitative Modules
New in v3.0: validation for non-numeric (Positive/Negative, Detected/Not Detected) assays such as PCR, antigen, and rapid tests.
| # | Module | Reference File | Key Acceptance Criterion | Status |
|---|
| 10 | Qualitative Correlation | 10_qualitative_correlation.csv | Concordance ≥ 95%, Kappa ≥ 0.80 | ☐ Pass ☐ Fail |
| 11 | Qualitative Carryover | 11_qualitative_carryover.csv | 0 false positives after high-positive sample | ☐ Pass ☐ Fail |
| 12 | Qualitative Precision (Reproducibility) | 12_qualitative_precision.csv | 100% agreement across replicates | ☐ Pass ☐ Fail |
4. Performance Qualification (PQ)
| Test ID | Procedure | Expected Criteria | Status |
|---|
| PQ-01 | Apply electronic digital signature to a completed report | Report transitions to locked, immutable state | ☐ Pass ☐ Fail |
| PQ-02 | Verify audit trail completeness | All modifications logged with user ID and timestamp | ☐ Pass ☐ Fail |
| PQ-03 | Multi-user concurrent access test | No data corruption or session conflicts | ☐ Pass ☐ Fail |
| PQ-04 | Generate and print/export PDF report | Report renders correctly with all sections | ☐ Pass ☐ Fail |
| PQ-05 | Director review and approval workflow | Report status changes from Pending → Approved | ☐ Pass ☐ Fail |
5. Summary & Conclusion
| Total Tests Performed | | Tests Passed | | Tests Failed | |
|---|
| Overall Status | ☐ VALIDATED — System approved for clinical use ☐ NOT VALIDATED — See deviation report |
|---|
Note: This validation was performed using ValidToolsLab™ cloud-based software (validtoolslab.com), version 3.0 with 13 validation modules. All calculations comply with current CLSI EP guidelines and CLIA '88 requirements. This document must be retained for a minimum of 2 years per CLIA regulations.
Performed By
Name: ________________________
Title: Medical Technologist / MLT
Date: ________________________
Reviewed & Authorized By
Name: ________________________
Title: Laboratory Director
Date: ________________________
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