System_Suitability_Parameters_Checker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface, user requirements and functional behaviour of System_Suitability_Parameters_Checker. The utility is intended for automated verification of laboratory, pharmacopoeial, analytical or manufacturing QC parameters using input.csv and producing a structured output.json result.

Domain limits and critical parameters

• • SST parameters integrate characteristics of the instrument, reagents, column, and operator.
• • USP <621> and Ph. Eur. 2.2.46 require passing SST before sample injection.
• • Key parameters: efficiency (N), peak symmetry (T), resolution (Rs), and repeatability (RSD).
• • Automatic SST check prevents wasting time on analyzing invalid batches and ensures data integrity.
• • N (Efficiency): Decrease in N indicates column degradation or poor packing.
• • T (Tailing): High T (>2.0) leads to integration errors and worse resolution.
• • Rs (Resolution): Rs < 1.5 means incomplete peak separation, critical for impurity quantification.
• • RSD (Precision): High RSD (>2.0%) indicates problems with pump, autosampler, or detector.
• • Comprehensive check of all main SST parameters.
• • Compliance with USP <621> and Ph. Eur. 2.2.46 requirements.
• • Generation of clear PASS/FAIL status to block invalid data.
• • Theoretical Plates (N): >= 2000
• • Tailing Factor (T): <= 2.0
• • Resolution (Rs): >= 1.5
• • RSD (%): <= 2.0
• • Column Efficiency (N): ≥2000 theoretical plates

URS — User Requirements Specification

input.csv contract

BatchNumber,N,Tailing,Resolution,RSD,CapacityFactor
SST-HPLC-2026-001,5500,1.1,2.5,0.8,3.5
SST-HPLC-2026-002,2100,1.8,1.6,1.9,2.1
SST-FAIL-2026-003,1500,2.5,1.2,3.5,1.5

FS — Functional Specification

Example output.json

{
  "utilityId": "system-suitability-parameters-checker",
  "utilityName": "System_Suitability_Parameters_Checker",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "SST-HPLC-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "N",
      "value": "5500",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Tailing",
      "value": "1.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Resolution",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RSD",
      "value": "0.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "CapacityFactor",
      "value": "3.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "generatedFor": "QA/QC review and LIMS integration"
}

Traceability matrix

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator, documentation and test set.
• Retain input.csv, output.json, executable version, documentation and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits must be verified against the approved specification, local SOPs and registration dossier.