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FDA 21 CFR Part 11 API

Access FDA 21 CFR Part 11 data programmatically. 24 controls, 5 domains, and cross-framework mappings to 692 frameworks via REST API or MCP.

24
Controls
5
Domains
474+
Mappings
Free
API Price

Add to Claude Desktop or Cursor

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.

REST API Examples

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"

SDK Installation

Python (Langchain)

pip install theartofservice-compliance

npm (MCP Server)

npx @theartofservice/compliance-mcp

Frequently Asked Questions

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: 24 controls across 5 domains, plus cross-framework mappings to 692 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 24 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 819,000+ 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 692 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 $49/month with 10,000 calls included. No credit card required for free tier.

Start using the FDA 21 CFR Part 11 API today

No signup required for 10 free API calls per day. Create a free account for 100 calls/month.

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