RunSummaryJsonExporter

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of RunSummaryJsonExporter for Run Summary JSON Exporter.

Domain limits and critical parameters

• Provides machine-readable run summary export per CAP/CLIA §GEN.48800, ISO 15189 §7.4, HL7 FHIR Genomics, GA4GH Run Metadata Schema and FDA 21 CFR Part 11: 9 mandatory sections (run_metadata, pre_analytical_summary, sequencing_summary, enrichment_summary, variant_calling_summary, interpretation_summary, qc_decisions, signout_summary, audit_trail), schema version compatibility (3.0.0–3.2.0), JSON syntax validation, numeric field validity (no NaN/Inf), ISO 8601 UTC timestamps, audit trail completen
• ⚠️ Critical: Run summary JSON is SINGLE SOURCE OF TRUTH for downstream systems. Missing audit trail = 21 CFR Part 11 / ISO 15189 VIOLATION; export must be blocked. Cross-section inconsistency indicates pipeline bug. Schema versioning mandatory; breaking changes require major version bump. Timestamps MUST be UTC. Null in required fields = incomplete export. Size >5 MB may cause API timeouts. Tool validates STRUCTURE AND CONSISTENCY only; does not verify scientific correctness of metrics within. D

URS — User Requirements Specification

input.csv contract

RunId,AssayName,Platform,SchemaVersion,JsonSyntaxValid,HasRunMetadata,HasPreAnalytical,HasSequencing,HasEnrichment,HasVariantCalling,HasInterpretation,HasQcDecisions,HasSignout,HasAuditTrail,NumericFieldsValid,TimestampsIso8601,AuditTrailComplete,CrossSectionConsistent,JsonSizeKb,NullRequiredFields,BackwardCompatible
RUN-2026-0142,NSCLC_CGP_Panel,NovaSeq_6000,3.2.0,true,true,true,true,true,true,true,true,true,true,true,true,true,true,48.5,0,true
RUN-2026-0143,BRCA1_2_Germline,NextSeq_2000,3.2.0,true,true,true,true,false,true,true,true,true,false,false,false,false,false,32.1,4,false

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "runsummaryjsonexporter",
  "utilityFolder": "RunSummaryJsonExporter",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "RunId",
      "value": "RUN-2026-0142",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "AssayName",
      "value": "NSCLC_CGP_Panel",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "Platform",
      "value": "NovaSeq_6000",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "SchemaVersion",
      "value": "3.2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "JsonSyntaxValid",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "HasRunMetadata",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "HasPreAnalytical",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "HasSequencing",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "HasEnrichment",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "HasVariantCalling",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "HasInterpretation",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "HasQcDecisions",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-012"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "RunSummaryJsonExporter.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.