EnvironmentalMonitoringTrendUtility

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of EnvironmentalMonitoringTrendUtility for Environmental Monitoring Trend Utility.

Domain limits and critical parameters

• ℹ️ Utility performs statistical analysis of historical microbiological monitoring data (CFU) for production zones according to EU GMP Annex 1 and ISO 14644 requirements:
• • Shewhart Control Charts: Calculation of mean background level, standard deviation, and control limits (UCL/LCL).
• • Utility helps detect "slow drift" in zone cleanliness before Action Limits are exceeded.
• SampleID,LocationType,CFU_Count,ActionLimit,SamplingDate
• ⚠️ CRITICAL:
• • Action Limit Exceedance: Requires immediate investigation and Corrective Actions (CAPA).
• • Stratification: Data must be analyzed separately for each zone (Grade A, B, C, D) and sampling type (air, surfaces).
• • Compliance with EU GMP Annex 1 (2022) requirements
• Critical parameters:
• 1. Data Purity: Use only results that have passed primary laboratory verification.
• ⚠️ Note: Unlike simple exceedance counting, this utility assesses the dynamics of microbiological background changes, which is a requirement of the modern approach to contamination risk management.

URS — User Requirements Specification

input.csv contract

SampleID,LocationType,CFU_Count,ActionLimit,SamplingDate
EM-2025-001,Grade A,0,1,2025-01-10
EM-2025-002,Grade A,0,1,2025-01-17
EM-2025-003,Grade A,1,1,2025-01-24

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "environmentalmonitoringtrendutility",
  "utilityFolder": "EnvironmentalMonitoringTrendUtility",
  "package": "Vet",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "SampleID",
      "value": "EM-2025-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "LocationType",
      "value": "Grade A",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "CFU_Count",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "ActionLimit",
      "value": "1",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "SamplingDate",
      "value": "2025-01-10",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "EnvironmentalMonitoringTrendUtility.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.