PanelManufacturingLotChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of PanelManufacturingLotChecker for Panel Manufacturing Lot Checker.

Domain limits and critical parameters

• Performs incoming lot quality control per EU IVDR Annex I §1.6, FDA QSR 820, ISO 13485, CAP GEN.48800 and IVD GMP: Certificate of Analysis verification (present, specs met), oligonucleotide physical characterization (concentration 90–110 µM, HPLC purity ≥95%, size profile, A260/A280 1.8–2.2), functional testing on reference samples (on-target ≥70%, uniformity ≥80%, mean depth ≥500×, fold-80 ≤2.0×, zero critical region blind spots), contamination checks (NTC clean, cross-contamination ≤0.1%, no h
• ⚠️ Critical: Lot-to-lot variability is primary source of systematic errors in targeted NGS. CoA alone is INSUFFICIENT without functional reference testing. NTC contamination = automatic lot REJECT. Drift |Z|>2 indicates potential manufacturing change requiring investigation. Every new lot must be tested BEFORE clinical use. Parallel old/new lot testing recommended during transition. Tool assesses LOT QUALITY only; does not replace full panel validation at first implementation or version change.

URS — User Requirements Specification

input.csv contract

LotNumber,PanelName,Manufacturer,ManufactureDate,ExpiryDate,CatalogNumber,CoA_Present,CoA_SpecsMet,CoA_Issues,OligoConcentration_uM,MinOligoConcentration_uM,MaxOligoConcentration_uM,OligoPurity_Percent,MinOligoPurity_Percent,SizeProfile_Mean_bp,SizeProfile_Target_bp,SizeProfile_Tolerance_bp,A260_A280_Ratio,MinA260_A280,MaxA260_A280,OnTargetRate_Percent,MinOnTargetRate_Percent,Uniformity_Percent,MinUniformity_Percent,MeanDepth_X,MinMeanDepth_X,Fold80_BasePenalty,MaxFold80,CriticalRegions_BelowThreshold,TotalCriticalRegions,NoTemplateControl_Clean,CrossContamination_Estimate_Percent,MaxCrossContamination_Percent,HumanDNA_Contamination_Detected,HistoricalMean_OnTarget,HistoricalSD_OnTarget,HistoricalMean_Uniformity,HistoricalSD_Uniformity,MaxZScore_Allowed,BarcodeMatch,LotSequence_Verified,PreviousValidatedLot,StorageCondition_Met,RequiredStorage,ColdChain_Maintained,FreezeThawCycles,MaxFreezeThawCycles
LOT-2026-0451,OncoPanel_500,Agilent,2026-05-15,2027-05-15,G9999A,true,true,,102.5,90,110,98.2,95,118,120,10,1.95,1.8,2.2,84.5,70,92.0,80,820,500,1.2,2.0,0,150,true,0.02,0.1,false,83.0,2.5,91.5,1.8,2.0,true,true,LOT-2026-0389,true,-20°C,true,0,3
LOT-2026-0467,HemePanel_300,Twist,2026-06-01,2027-06-01,TB-HM-300,true,true,,95.0,90,110,96.5,95,125,120,10,2.05,1.8,2.2,68.0,70,72.0,80,380,500,3.2,2.0,8,120,false,0.35,0.1,true,81.0,2.0,89.0,1.5,2.0,true,true,LOT-2026-0412,true,-20°C,true,1,3

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "panelmanufacturinglotchecker",
  "utilityFolder": "PanelManufacturingLotChecker",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "LotNumber",
      "value": "LOT-2026-0451",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "PanelName",
      "value": "OncoPanel_500",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "Manufacturer",
      "value": "Agilent",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "ManufactureDate",
      "value": "2026-05-15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "ExpiryDate",
      "value": "2027-05-15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "CatalogNumber",
      "value": "G9999A",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "CoA_Present",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "CoA_SpecsMet",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "CoA_Issues",
      "value": "",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "OligoConcentration_uM",
      "value": "102.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "MinOligoConcentration_uM",
      "value": "90",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "MaxOligoConcentration_uM",
      "value": "110",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-012"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "PanelManufacturingLotChecker.documentation.html"
  }
}

Traceability matrix

IQ/OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating validator, documentation and test set.
• Retain input.csv, output.json, executable version and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.