As AI transforms biopharmaceutical and medical device manufacturing, regulatory bodies are establishing clear guardrails. EU GMP Annex 22 represents the most significant development in AI regulation for our industry to date. Merit Solutions CEO Bill Burke breaks down the critical requirements, validation expectations, and preparation steps manufacturers should take now. This article was originally shared on LinkedIn and is republished here for our community. EU GMP Annex 22: The New AI Regulatory Standard for Biopharma and Medical Device Manufacturing The European Commission has taken a decisive step in defining the regulatory future of AI in biopharmaceutical and medical device manufacturing. On July 7, 2025, it released the draft EU GMP Annex 22: Artificial Intelligence—a six-page...