LabWare_CDS_Bridge_Connector

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface, user requirements and functional behaviour of LabWare_CDS_Bridge_Connector. 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

• • Manual data entry is prone to errors and violates ALCOA+ principles.
• • Direct integration via CDS (Chromatography Data System) Bridge allows automatic result loading.
• • This utility serves as a universal adapter for any script or instrument, forming a unified data exchange standard.
• • Supports audit trail recording system actions during data processing.
• • "SampleID" field must exactly match the sample identifier in LIMS.
• • "BatchNumber" field is used for grouping samples into batches.
• • PASS/FAIL statuses must be set based on product specifications.
• • Audit Trail must contain a record of each processing stage (import, calculation, finalization).
• • Universal output format for any analytical methods.
• • Compliance with 21 CFR Part 11 and EU GMP Annex 11 requirements.
• • Easily extensible for adding new parameters.
• • Structure: Header/Samples/Results
• • Audit Trail: Present
• • Status Codes: 1 (Pass), 0 (Fail), -1 (Error)

URS — User Requirements Specification

input.csv contract

BatchNumber,SampleID,Value1,Value2,Value3
LW-BATCH-001,SMP-001-A,99.5,0.1,0.05
LW-BATCH-001,SMP-001-B,98.2,0.2,0.08
LW-BATCH-002,SMP-002-A,92.0,0.5,0.15

FS — Functional Specification

Example output.json

{
  "utilityId": "labware-cds-bridge-connector",
  "utilityName": "LabWare_CDS_Bridge_Connector",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "LW-BATCH-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SampleID",
      "value": "SMP-001-A",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Value1",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Value2",
      "value": "0.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Value3",
      "value": "0.05",
      "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.