Cross-Cutting

AI & Automation in Compliance

AI is genuinely useful in compliance, for specific, bounded tasks where the risk of error is caught downstream by a human reviewer. It is not useful as an autonomous decision-maker in regulated workflows. Building AI tools for GxP requires understanding this distinction from the start, then designing the validation infrastructure around it before writing a line of code.

Regulatory basis

FDA CSA Draft Guidance (Sep 2022) 21 CFR Part 11 FDA AI/ML Framework

Articles in this pillar

Intermediate

Building AI Tools for GxP: What Actually Works

Practical lessons from building AI-assisted compliance tools in regulated pharma environments, where the hype ends and the useful stuff begins.

5 min→

Advanced

Validating AI-Enabled GxP Systems: The Framework That's Still Being Built

How to approach validation for AI and machine learning systems in regulated pharmaceutical environments, what's different about AI validation, the current regulatory gaps, and a practical framework for getting it right now.

9 min→