Artificial Intelligence (AI)

AI in Regulated Manufacturing: Beyond the Hype to Real-World Implementation 

by | Feb 10, 2026 | , , , , , , , ,

The artificial intelligence conversation has reached a fever pitch across industries, and life science manufacturing is no exception. For GMP-regulated manufacturers operating under FDA, EMA, and MHRA oversight, however, the path to AI adoption looks fundamentally different than what you're reading about in mainstream tech headlines.  The work ahead is clear: helping our customers leverage this new capability in ways that improve product quality, enhance customer experience, and drive operational efficiency across their organizations.  The Reality Check: Not All AI Models Are Created Equal  The ability to leverage AI will likely prove more impactful than even most people realize. The capability to transform...

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EU GMP Annex 22: The New AI Regulatory Standard for Biopharma & Medical Device Manufacturing

by | Nov 26, 2025 | , , , , , , ,

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...

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