{
  "node_id": "us-fda-21-cfr-part-11-electronic-records-signatures",
  "title": "US FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures in FDA-Regulated Industries",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "2.0.0",
  "last_updated": "2026-05-09",
  "bluf": "US FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures for FDA-regulated activities…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "eu_taxonomy",
      "sdg_alignment",
      "iso_standard",
      "industry_mapping"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "fda-21-cfr-210-211-current-good-manufacturing-practice",
    "eu-pharma-gcp-directive-2005-28-clinical-trials-conduct"
  ],
  "primary_citations_count": 8,
  "workflow_steps_count": 8,
  "schema_fields_count": 19,
  "citation_preview": [
    {
      "source": "US FDA 21 CFR Part 11 - Subpart B (Electronic Records): Section 11.10 Controls for Closed Systems; Section 11.30 Controls for Open Systems",
      "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11",
      "type": "primary_legislation"
    },
    {
      "source": "US FDA 21 CFR Part 11 - Subpart C (Electronic Signatures): Sections 11.200-11.300 Electronic Signature Requirements",
      "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11",
      "type": "primary_legislation"
    }
  ]
}