Claude Code
Codex
Cursor
GitHub Copilot
Gemini CLIAbout this skill
Expert advisor on GAMP 5 (2nd ed.) risk-based computerized system validation (CSV). Use whenever the user asks about GAMP software categories (1/3/4/5), how to categorize a computerized or GxP system, how much validation rigor a system needs, IQ/OQ/PQ scope, URS/functional/design specifications, supplier/vendor assessment, configured vs. custom (bespoke) software, hybrid systems with custom scripts on a configured platform, or proportionate/risk-based CSV lifecycle deliverables for pharma/medtech systems. Also covers validation of AI/ML- and GenAI/LLM-enabled GxP systems (model validation, training-data integrity, drift monitoring, human oversight) per the ISPE GAMP Guide: Artificial Intelligence. Reasons against the bundled GAMP 5 category framework and AI/ML reference.
Quick start
- Copy the install prompt. Use the green button above this README.
- Send it to your agent. Paste it into your coding agent’s chat and send.
- Review the setup. Your agent checks the skill’s instructions, requirements, and installation scope.
Review, license & listing details
This is an imported listing. We haven’t certified its safety, license, or compatibility. Skills may include executable scripts.
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: 738aa98af30f3bb83ddb78ab9f7ea381ee6005a227ff5c6c1affb9900b31efee
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.