What does FDA-EMA · Good AI Practice (Jan 2026) cover?

Data governance, performance, life-cycle management. It applies to: Drug-development AI.

What does the Regulayer pack for FDA-EMA · Good AI Practice (Jan 2026) prove?

Maps receipts to the joint guiding principles for AI in drug development. The record is signed and tamper-evident, and anyone can verify it free, without an account.

Regulayer / The 114 laws / Pharma & life sciences

FDA-EMA · Good AI Practice (Jan 2026)

Data governance, performance, life-cycle management.

Applies to: Drug-development AI.

What the signed record shows

Maps receipts to the joint guiding principles for AI in drug development.

The proof is a signed, tamper-evident record. Anyone can check it, free, without an account, and nothing has to leave the building to make it. Evidence, not a promise.

Citation: Principles 6, 8, 9, 2

In the same family

FDA · 21 CFR Part 11Electronic records & signatures EU GMP · Annex 11Computerised-systems integrity FDA · GMLPGood Machine Learning Practice

What to do about it

Seven days free, then $349 a month.

A signed record of which AI you used and what you checked, sealed to the exact file you deliver, made on your own machine and checkable free by anyone you send it to.

Start the free week Or verify a real record, free →

Part of the Regulayer proof catalogue: 114 laws and standards, one sealed engine. This page is a product description, not legal advice.