{
  "_notice": "DRAFT EXAMPLE ONLY. A script cannot approve, close, or determine the effectiveness or regulatory adequacy of a CAPA.",
  "metadata": {
    "register_id": "<controlled CAPA register ID>",
    "review_date": "<YYYY-MM-DD>",
    "owner": "<CAPA system owner>",
    "status": "draft",
    "evidence": [],
    "approval": {
      "status": "pending",
      "by": "",
      "date": ""
    },
    "source_refs": []
  },
  "capas": [
    {
      "id": "<CAPA ID>",
      "owner": "<CAPA owner>",
      "status": "open",
      "source_event": "<complaint/audit/nonconformity/supplier/risk signal ID>",
      "problem_statement": "<factual problem statement>",
      "scope": "<known and potential systemic extent>",
      "correction_or_containment": "<immediate action and evidence>",
      "evidence": [],
      "source_refs": [],
      "approval": {
        "status": "pending",
        "by": "",
        "date": ""
      },
      "risk_assessment": {
        "patient_and_user_impact": "<assessment>",
        "product_and_process_impact": "<assessment>",
        "reportability_review": "<authorized reportability/vigilance decision reference>",
        "decision": "escalate",
        "decision_rationale": "<rationale>",
        "owner": "<risk/RAQA owner>",
        "evidence": [],
        "approval": {
          "status": "pending",
          "by": "",
          "date": ""
        }
      },
      "investigation": {
        "method": "<selected method and rationale>",
        "root_cause_or_justified_conclusion": "<supported conclusion>",
        "systemic_extent_review": "<similar products/processes/sites review>",
        "owner": "<investigation owner>",
        "evidence": [],
        "approval": {
          "status": "pending",
          "by": "",
          "date": ""
        }
      },
      "actions": [
        {
          "id": "<action ID>",
          "description": "<action tied to supported cause/risk>",
          "owner": "<action owner>",
          "due_date": "<YYYY-MM-DD>",
          "implemented_date": "",
          "evidence": [],
          "approval": {
            "status": "pending",
            "by": "",
            "date": ""
          }
        }
      ],
      "change_control_refs": [
        "<change record ID>"
      ],
      "effectiveness": {
        "plan": "<planned check>",
        "objective_acceptance_criteria": "<measurable criteria>",
        "baseline": "<baseline/comparator>",
        "sample_or_observation_window": "<risk-based sample/window>",
        "due_date": "<YYYY-MM-DD>",
        "owner": "<effectiveness owner>",
        "independent_reviewer": "<independent reviewer>",
        "result": "pending",
        "conclusion": "",
        "review_date": "",
        "evidence": [],
        "approval": {
          "status": "pending",
          "by": "",
          "date": ""
        }
      },
      "closure_date": "",
      "closure_summary": "",
      "cancellation_rationale": ""
    }
  ]
}