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FDA 21 CFR Part 11 API

How do I query FDA 21 CFR Part 11 data over an API?

Point a GET request at api.theartofservice.com/api/agent/frameworks/FDA 21 CFR Part 11, or add the MCP server to Claude Desktop or Cursor with the config below. You get 13 controls, 7 domains and every cross-framework mapping this standard carries. The free tier is 10 calls a day and needs no signup or API key.

13
Controls
7
Domains
86+
Mappings
Free
API Price

Add FDA 21 CFR Part 11 to Claude Desktop or Cursor in one config block

Copy this config into your MCP client to start querying FDA 21 CFR Part 11 data with AI:

{
  "mcpServers": {
    "compliance": {
      "url": "https://api.theartofservice.com/mcp"
    }
  }
}

No API key required for up to 10 calls/day. Works with Claude Desktop, Cursor, Windsurf, and any MCP-compatible client.

Three curl calls that return FDA 21 CFR Part 11 data

Get FDA 21 CFR Part 11 details

curl https://api.theartofservice.com/api/agent/frameworks/FDA%2021%20CFR%20Part%2011

List all FDA 21 CFR Part 11 controls

curl https://api.theartofservice.com/api/agent/frameworks/FDA%2021%20CFR%20Part%2011/controls

Map FDA 21 CFR Part 11 to another framework

curl "https://api.theartofservice.com/api/agent/cross-map?source=FDA%2021%20CFR%20Part%2011&target=SOC%202"

Install the Python or npm client

Python (Langchain)

pip install theartofservice-compliance

npm (MCP Server)

npx @theartofservice/compliance-mcp

Questions developers ask about the FDA 21 CFR Part 11 API

Is there an API for FDA 21 CFR Part 11?▾
Yes. The Art of Service provides a REST API and MCP server with full FDA 21 CFR Part 11 data: 13 controls across 7 domains, plus cross-framework mappings to 686 other compliance frameworks. Free tier includes 10 calls/day with no signup.
How do I access FDA 21 CFR Part 11 controls programmatically?▾
Use the Compliance Intelligence API at api.theartofservice.com. Call GET /api/agent/frameworks/FDA%2021%20CFR%20Part%2011/controls to retrieve all 13 controls with codes, titles, and descriptions. Supports filtering by domain.
Can I map FDA 21 CFR Part 11 controls to other frameworks?▾
Yes. The API provides cross-framework mapping with 311K+ verified control-to-control mappings. Call GET /api/agent/cross-map?source=FDA%2021%20CFR%20Part%2011&target=TARGET to map FDA 21 CFR Part 11 controls to any of 686 frameworks.
Does the FDA 21 CFR Part 11 API work with Claude, ChatGPT, or Cursor?▾
Yes. The API is available as an MCP (Model Context Protocol) server. Add it to Claude Desktop, Cursor, or any MCP-compatible client with a single JSON config snippet. AI agents can then query FDA 21 CFR Part 11 data directly.
How much does the FDA 21 CFR Part 11 API cost?▾
Anonymous access is free (10 calls/day). Free accounts get 100 calls/month. Professional plans start at $149/month with 10,000 calls included. No credit card required for free tier.

What FDA 21 CFR Part 11 actually requires

The API returns the data. If you want the standard explained first, with its controls, domains and the frameworks it overlaps with, that is on the FDA 21 CFR Part 11 framework page.

FDA 21 CFR Part 11 controls, domains and mappings →
Written and maintained by Gerard Blokdyk, The Art of Service.Last updated .

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