RabiesVaccinePotencyAssayReviewer

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of RabiesVaccinePotencyAssayReviewer for Rabies Vaccine Potency Assay Reviewer.

Domain limits and critical parameters

• Rabies Vaccine Potency Assay Reviewer — Rabies Vaccine Potency Test Review
• ℹ️ Utility performs automatic verification of acceptance criteria for rabies vaccine potency tests according to Ph. Eur. 2.7.13 and WHO guidelines:
• • Potency Calculation: Determination of activity in International Units (IU) relative to international standard.
• • Compliance Check: Comparison with minimum requirements (≥ 2.5 IU/dose for humans, ≥ 1.0 IU/dose for animals).
• • Rabies potency test is one of the strictest biological tests.
• RabiesVaccinePotencyAssayReviewer.exe → demo mode (console output)
• RabiesVaccinePotencyAssayReviewer.exe input.csv output.json → evaluate your data
• BatchNumber,VaccineType,StdReference_IU,Slope_Factor,ControlGroup_SurvivalRate,ChallengeControl_MortalityRate,Calculated_Potency_IU,MinPotency_Requirement
• Rabies is a disease with 100% lethality. Vaccine efficacy is critically important.
• ⚠️ CRITICAL:
• • Challenge Control: Mortality in this group must be high (usually >80%), otherwise virus was weak or dose insufficient.
• • Negative Control: Survival must be close to 100% to exclude accidental animal death.
• • IU Limit: For human vaccines, 2.5 IU limit is a rigid WHO requirement.
• • Comparison of obtained potency with regulatory requirements (Human/Vet)
• Critical parameters:
• • Challenge Mortality: ≥ 80%
• • Negative Control Survival: ≥ 90-100%
• • Calculated Potency: ≥ 2.5 IU (Human) / ≥ 1.0 IU (Vet)

URS — User Requirements Specification

input.csv contract

BatchNumber,VaccineType,StdReference_IU,Slope_Factor,ControlGroup_SurvivalRate,ChallengeControl_MortalityRate,Calculated_Potency_IU,MinPotency_Requirement
RAB-HUMAN-2026-001,Human,1.0,1.2,1.0,0.95,4.8,2.5
RAB-VET-2026-002,Veterinary,1.0,1.1,0.9,0.60,1.5,1.0
RAB-HUMAN-2026-003,Human,1.0,1.15,1.0,0.90,2.1,2.5

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "rabiesvaccinepotencyassayreviewer",
  "utilityFolder": "RabiesVaccinePotencyAssayReviewer",
  "package": "Vet",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "RAB-HUMAN-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "VaccineType",
      "value": "Human",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "StdReference_IU",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "Slope_Factor",
      "value": "1.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "ControlGroup_SurvivalRate",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "ChallengeControl_MortalityRate",
      "value": "0.95",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "Calculated_Potency_IU",
      "value": "4.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "MinPotency_Requirement",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "RabiesVaccinePotencyAssayReviewer.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.