Score your AI governance against the new FDA/EMA principles.
The FDA and EMA released joint guiding principles on Good AI Practice in Drug Development in January 2026. The principles aren’t yet binding guidance, but they signal the framework regulators will apply to AI in GMP environments. If your organization uses AI in any workflow touching Good Practice (GxP) quality regulations, you need a clear view of where your governance stands today.
Our AI in GxP Operations Readiness Checklist gives you 35 specific assessment points across seven governance areas. Use the checklist to evaluate:
- Whether each AI tool has a documented context of use and assigned risk tier
- Data governance practices, including ALCOA+ alignment for AI inputs
- Model validation evidence, golden set controls, and human-AI interaction testing
- Lifecycle monitoring plans, drift triggers, and revalidation pathways
- Vendor due diligence aligned to draft EU GMP Annex 11 expectations
Score your maturity from Emerging to Audit-Ready, identify governance gaps, and prioritize remediation before AI becomes a routine inspection topic.
Start here: score your two highest-risk AI tools against the seven governance areas before your next vendor review. Any area where your only evidence is a vendor’s marketing claim rather than your own documentation is a gap.