{
  "slug": "part-11-who-signed-the-record",
  "title": "Part 11 was written in 1997. It never imagined the analyst was a model",
  "summary": "When an AI agent reconciles the data and a human clicks sign, what exactly is being attested? Part 11 asks a question the audit trail cannot answer.",
  "lede": "A reconciliation agent proposes two hundred data corrections. A data manager reviews them in eleven minutes and signs. The audit trail is complete, the system is validated, and nobody in the room can say what the signature actually attests to.",
  "date": "2026-09-24",
  "reading_time": "17 min read",
  "category": "Regulated",
  "tags": ["21 CFR Part 11", "electronic signatures", "GxP", "AI agents", "data integrity", "computer system validation", "clinical operations"],
  "image": "https://cdn.twc.sh/images/igcache/Part%2011%20Electronic%20Signatures/1200_630/blog.jpg",
  "url": "/blog/part-11-who-signed-the-record.html",
  "wordcount": 3828,
  "related": ["approval-theater", "esignature-proves-the-mailbox", "audit-trail-design"],
  "schema": "Article"
}