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Compliance API

ProBeya provides a comprehensive compliance suite covering three domains: Compliance Radar for regulatory requirement tracking, Inspection Shield for pre-inspection simulation and readiness scoring, and IFQHC for competency framework management. All endpoints enforce strict multi-tenant isolation via organizationId.

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Compliance Radar

Track regulatory requirements across frameworks (EU GMP, FDA 21 CFR, ISO) with risk-level classification, periodic assessments, and a dashboard aggregation view.

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Endpoints

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POST /api/v1/compliance/requirements

Create a new compliance requirement representing a single clause or control from a regulatory framework.

tRPC: complianceRadar.createRequirement Auth: Bearer token required (scope: write:items) or session cookie Org context: Required

Parameters:

Example:

curl -X POST -H "Authorization: Bearer probeya_sk_live_..." \
     -H "Content-Type: application/json" \
     -d '{"framework":"EU GMP Annex 11","clause":"4.8","title":"Data integrity controls","riskLevel":"high"}' \
     "https://acme.probeya.com/api/v1/compliance/requirements"

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GET /api/v1/compliance/requirements

List all compliance requirements with filtering, search, and pagination.

tRPC: complianceRadar.listRequirements Auth: Bearer token required (scope: read:items) or session cookie Org context: Required

Parameters:

Response:

{
  "items": [
    {
      "id": "clx9cr001",
      "framework": "EU GMP Annex 11",
      "clause": "4.8",
      "title": "Data integrity controls",
      "status": "gap_identified",
      "riskLevel": "high",
      "applicability": "applicable",
      "nextAssessmentDue": "2026-06-01T00:00:00.000Z"
    }
  ],
  "total": 42
}

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POST /api/v1/compliance/assessments

Record a point-in-time compliance assessment for a requirement. Automatically updates the parent requirement’s status and lastAssessedAt timestamp.

tRPC: complianceRadar.createAssessment Auth: Bearer token required (scope: write:items) or session cookie Org context: Required

Parameters:

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GET /api/v1/compliance/dashboard

Aggregated compliance posture dashboard with counts grouped by status, risk level, and framework.

tRPC: complianceRadar.getDashboard Auth: Bearer token required (scope: read:items) or session cookie Org context: Required

Response:

{
  "total": 127,
  "byStatus": [
    { "status": "compliant", "count": 85 },
    { "status": "gap_identified", "count": 22 },
    { "status": "remediation_in_progress", "count": 15 },
    { "status": "non_compliant", "count": 5 }
  ],
  "byRiskLevel": [
    { "riskLevel": "low", "count": 40 },
    { "riskLevel": "medium", "count": 50 },
    { "riskLevel": "high", "count": 30 },
    { "riskLevel": "critical", "count": 7 }
  ],
  "byFramework": [
    { "framework": "EU GMP Annex 11", "count": 42 },
    { "framework": "FDA 21 CFR Part 11", "count": 38 }
  ]
}

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Inspection Shield

Run simulated inspections using GMP, FDA, ISO, or custom checklists. Capture findings per checkpoint item, compute readiness scores, and track completion.

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tRPC-Only Inspection Procedures

Checklist lifecycle: draft → active → archived

Checkpoint criticality levels: critical, major, minor, info

Finding results per checkpoint: pass, fail, na

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IFQHC Competency Management

The IFQHC (Information-Formation-Qualification-Habitude-Confirmation) model provides a strict competency progression framework used in regulated manufacturing.

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IFQHC Level Hierarchy

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tRPC-Only IFQHC Procedures

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Error Codes