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Part11 Advisor

Agent skill
1 skill

Expert advisor on FDA 21 CFR Part 11 (electronic records and electronic signatures). Use whenever the user asks about Part 11 compliance, electronic records or signatures, audit trails, closed vs. open systems, e-signature components/controls, record retention or copies for the agency, ALCOA+ data integrity under Part 11, a Part 11 gap or inspection readiness, or whether a computerized/GxP system meets §11.10, §11.30, §11.50, §11.70, §11.100, §11.200, or §11.300. Reasons against the bundled verbatim regulation text and cites the exact paragraph.

Install with
Claude CodeCodexCursorGitHub CopilotGemini CLI

Supported by the Atlas install prompt. Skill-specific requirements vary.

Skill stats

Skills1CategoryGeneralStars0

About this skill

Expert advisor on FDA 21 CFR Part 11 (electronic records and electronic signatures). Use whenever the user asks about Part 11 compliance, electronic records or signatures, audit trails, closed vs. open systems, e-signature components/controls, record retention or copies for the agency, ALCOA+ data integrity under Part 11, a Part 11 gap or inspection readiness, or whether a computerized/GxP system meets §11.10, §11.30, §11.50, §11.70, §11.100, §11.200, or §11.300. Reasons against the bundled verbatim regulation text and cites the exact paragraph.

Quick start

  1. Copy the install prompt. Use the green button above this README.
  2. Send it to your agent. Paste it into your coding agent’s chat and send.
  3. Review the setup. Your agent checks the skill’s instructions, requirements, and installation scope.
Review, license & listing details
Review the source before using this skill

This is an imported listing. We haven’t certified its safety, license, or compatibility. Skills may include executable scripts.

Automated security scan: Partial

Only SKILL.md was scanned. Supporting files and scripts were not checked. No safety grade has been assigned.

0 potential findings · Scanned 11/4/2026 · Scanner 0.2.1

Content SHA-256: a814e0914371a0f9d0f8666110fa5a6e11f907d16e646714fb3d42a2292162c1

About scan coverage and limitations

About this listing

Category
General
Reported license
MIT
Listing language (estimated)
English
Review status
Not individually reviewed
Agent compatibility
Atlas installation supports Claude Code, Codex, and Cursor. Skill-specific dependencies and features are checked during setup.
Part11 Advisor | Agent Skills Atlas