Purpose

Define user requirements for a standalone FUZKK utility that accepts laboratory CSV data, evaluates the records using limits embedded in code, and produces LabWare-compatible JSON.

Scope

The utility is intended for preliminary QC/QA review, integration testing, LIMS/LabWare flow and evidence-trail preparation. Final release decisions remain under the laboratory's validated procedure and responsible personnel.

Users

QC analyst, QA reviewer, CSV/validation engineer, LIMS/LabWare integration engineer, responsible laboratory specialist.

User requirements

1. The utility shall run without arguments and print its self-description, a built-in input.csv example from GetDemoData(), and demo evaluation for the embedded records.
2. The utility shall run with two arguments: input.csv output.json.
3. The utility shall not read input.csv and shall not write output.json when started without arguments.
4. CSV numeric values shall be parsed using CultureInfo.InvariantCulture.
5. Output shall be generated as LabWare-compatible JSON with Header, Samples, Results, Status, StatusCode, ErrorMessage, Description and DescriptionEN.
6. For PASS records, ErrorMessage shall be an empty string.
7. Embedded limits shall follow this priority: Ph. Eur. → British Pharmacopoeia / UK implementation → EAEU / regional requirements → EMA/ICH/EU guidance → USP fallback.
8. If an exact monograph is not known, strict standard API limits are used where applicable: assay 98–102%, total impurities ≤1.0%, individual impurity ≤0.5%.
9. For biologics and mAb-like products, aggregation, sterility and endotoxin checks shall be included where relevant to the utility purpose.
10. If a parameter may arrive in different units, the unit shall be represented as a separate input field or explicitly reflected in the input.csv field name.

Input CSV

BatchNumber,ProductName,StandardCode,ComplianceScore_Percent,TraceabilityCoverage_Percent,CriticalOpenFindings_Count,MajorOpenFindings_Count,VerificationCoverage_Percent,ValidationCoverage_Percent,RiskControlVerification_Percent,UnresolvedSafetySignals_Count,EvidencePackageID
MD-STD-2026-001,Controlled device process,03_MedicalDeviceSoftwareSuite,98,97,0,1,96,95,98,0,DHF-DMR-RMF-001
MD-STD-2026-002,Incomplete evidence package,03_MedicalDeviceSoftwareSuite,88,84,1,4,82,80,86,1,DHF-DMR-RMF-002

input.csv fields

Utility description

Software Safety Class Checker — evidence/process metrics checker for medical devices

Software Safety Class Checker — evidence/process metrics checker for medical devices

ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite:
• compliance score
• traceability coverage
• open critical/major findings
• verification and validation coverage
• risk-control verification
• unresolved safety signals

⚠️ CRITICAL: Pharmacopoeial API limits are not applied to medical device utilities.
This utility uses hardcoded process thresholds for standards/evidence review.

Usage:
SoftwareSafetyClassChecker.exe → demo mode (console output)
SoftwareSafetyClassChecker.exe input.csv output.json → evaluate your data

Input format:
BatchNumber,ProductName,StandardCode,ComplianceScore_Percent,TraceabilityCoverage_Percent,CriticalOpenFindings_Count,MajorOpenFindings_Count,VerificationCoverage_Percent,ValidationCoverage_Percent,RiskControlVerification_Percent,UnresolvedSafetySignals_Count,EvidencePackageID

Example:
MD-STD-2026-001,Controlled device process,03_MedicalDeviceSoftwareSuite,98,97,0,1,96,95,98,0,DHF-DMR-RMF-001

— WHY IS THIS NEEDED?
The utility supports reproducible evidence package review:
• reduces manual checklist/Excel review
• produces PASS / WARNING / FAIL in LabWare-compatible JSON
• helps identify gaps before audit / technical file review
• supports CSV/CSA approach for repeated checks

⚠️ CRITICAL:
• Critical findings must be 0
• Traceability and risk-control verification must be high before readiness decisions
• The utility does not replace QA/RA sign-off or formal conformity assessment

Key features:
• One Program.cs
• Hardcoded process thresholds
• LabWare-compatible output.json
• Demonstration PASS/FAIL rows in input.csv

Critical parameters:
• Compliance score: ≥95%
• Traceability coverage: ≥95%
• Critical open findings: 0
• Major open findings: ≤2
• Verification coverage: ≥90%
• Validation coverage: ≥90%
• Risk-control verification: ≥95%

💡 Usage tips:
1. Use export from eQMS/ALM/requirements system as input.csv
2. Keep EvidencePackageID for audit trail
3. Do not use PASS as substitute for QA/RA sign-off
4. Change thresholds only through change control

⚠️ Note: This is not a pharmacopoeial utility; it is a standards/evidence utility for medical devices.

Traceability and limitations

• The URS is used as the source document for functional specification, CSV review and later validation work.
• This document does not replace an approved pharmacopoeial monograph, validated analytical method or internal product specification.
• For product-specific limits, the approved customer specification takes priority.

The functional specification describes the behaviour of the standalone FUZKK console utility, input-data format, evaluation algorithm and output JSON structure.

Functional flow

1. Main() checks the number of arguments.
2. If no arguments are provided: PrintHello() prints the description and built-in input.csv example, then RunDemoEvaluation() executes Evaluate() over GetDemoData() and prints demo JSON.
3. If two arguments are provided: RunWithFiles(input.csv, output.json) reads CSV, evaluates each record and writes LabWare-compatible JSON.
4. LoadData() uses CultureInfo.InvariantCulture and shall not be called in no-arguments mode.
5. Evaluate() returns a named tuple with BatchNumber, ProductName, Parameters, CriticalFailCount, WarningCount, Recommendation and RecommendationEN.
6. GetIssues() builds messages for ErrorMessage in WARNING/FAIL cases.

Evaluation rules

• PASS: CriticalFailCount = 0 and WarningCount = 0.
• WARNING: CriticalFailCount = 0 and WarningCount > 0.
• FAIL: CriticalFailCount > 0.
• ERROR: exception during reading or processing.
• ErrorMessage remains empty for PASS.
• Limits are embedded in Program.cs; no external limit configuration is required.

Input and fields

BatchNumber,ProductName,StandardCode,ComplianceScore_Percent,TraceabilityCoverage_Percent,CriticalOpenFindings_Count,MajorOpenFindings_Count,VerificationCoverage_Percent,ValidationCoverage_Percent,RiskControlVerification_Percent,UnresolvedSafetySignals_Count,EvidencePackageID
MD-STD-2026-001,Controlled device process,03_MedicalDeviceSoftwareSuite,98,97,0,1,96,95,98,0,DHF-DMR-RMF-001
MD-STD-2026-002,Incomplete evidence package,03_MedicalDeviceSoftwareSuite,88,84,1,4,82,80,86,1,DHF-DMR-RMF-002

Output JSON

{
  "Header": {
    "UtilityName": "SoftwareSafetyClassChecker",
    "Version": "1.0.0",
    "Timestamp": "UTC",
    "InstrumentID": "FUZKK-QC-WORKSTATION",
    "OperatorID": "Admin"
  },
  "Samples": [
    {
      "SampleID": "from BatchNumber",
      "BatchNumber": "from CSV",
      "ProductName": "from CSV",
      "TestName": "utility-specific test",
      "AnalysisCode": "utility-specific code",
      "Status": "PASS | WARNING | FAIL | ERROR",
      "StatusCode": "1 | 2 | 0 | -1",
      "ErrorMessage": "",
      "Description": "Russian recommendation",
      "DescriptionEN": "English recommendation",
      "Results": [
        {
          "ParameterName": "parameter",
          "ResultValue": 0.0,
          "UnitOfMeasure": "unit",
          "SpecificationLimit": "limit",
          "IsWithinSpec": true
        }
      ]
    }
  ]
}