{
  "_notice": "DRAFT EXAMPLE ONLY. Authorized humans must determine and approve applicability. This file cannot establish compliance, conformity, certification, or market access.",
  "metadata": {
    "intake_id": "<controlled intake ID>",
    "review_date": "<YYYY-MM-DD>",
    "owner": "<assigned role>",
    "status": "draft",
    "evidence": [],
    "approval": {
      "status": "pending",
      "by": "",
      "date": ""
    },
    "source_refs": [
      {
        "id": "SOURCE-LEDGER",
        "title": "Organization-controlled source ledger",
        "version_or_date": "<revision/date>",
        "url": "https://example.invalid/replace-with-controlled-official-source",
        "accessed": "<YYYY-MM-DD>"
      }
    ]
  },
  "organization": {
    "legal_name": "<legal entity>",
    "declared_lifecycle_role": "<declared role; not a legal determination>",
    "authorized_management_representative": "<named role>",
    "raqa_owner": "<named role>",
    "applicability_decision_owner": "<authorized RA/QA or legal role>"
  },
  "scope": {
    "lifecycle_activities": [
      "design-and-development"
    ],
    "sites": [
      {
        "id": "<site ID>",
        "name": "<site name>",
        "address": "<site address>",
        "activities": [
          "design-and-development"
        ],
        "owner": "<assigned role>",
        "status": "draft",
        "evidence": [],
        "approval": {
          "status": "pending",
          "by": "",
          "date": ""
        },
        "source_refs": []
      }
    ],
    "products": [
      {
        "id": "<product/family ID>",
        "family": "<product family>",
        "intended_use": "<controlled intended-use reference>",
        "classification_or_rationale": "<authorized classification decision reference>",
        "market_ids": [
          "<market ID>"
        ],
        "owner": "<assigned role>",
        "status": "draft",
        "evidence": [],
        "approval": {
          "status": "pending",
          "by": "",
          "date": ""
        },
        "source_refs": []
      }
    ],
    "markets": [
      {
        "id": "<market ID>",
        "jurisdiction": "<jurisdiction>",
        "applicability": "undetermined",
        "decision_rationale": "<authorized human decision and rationale>",
        "owner": "<assigned role>",
        "status": "draft",
        "evidence": [],
        "approval": {
          "status": "pending",
          "by": "",
          "date": ""
        },
        "source_refs": []
      }
    ],
    "outsourced_processes": [
      {
        "id": "<process ID>",
        "process": "<outsourced process>",
        "provider": "<provider>",
        "control_strategy": "<risk-based control strategy>",
        "owner": "<assigned role>",
        "status": "draft",
        "evidence": [],
        "approval": {
          "status": "pending",
          "by": "",
          "date": ""
        },
        "source_refs": []
      }
    ]
  }
}