Research, writing, and training from Brian Drapeau on how regulated life-sciences organizations decide what AI may do, govern it, and build the workforce capability to use it.
New GxP Frame research on a practical authorization method for AI-supported pharmaceutical quality work.
An online learning platform that builds AI capability for regulated life-sciences teams, from foundational literacy to role-based practitioner certification.
Visit lifesciencesai.academy →Brian Drapeau’s latest contributions on AI authority, governance, qualification, and the workforce constraints shaping regulated manufacturing.
Agentic AI changes the question from what a model can produce to what a system is allowed to decide.
EMA’s draft GMP Annex 22 sidelines LLMs in critical manufacturing, fueling a push for risk-based guardrails and human accountability.
Pharma’s AI ROI gap is not strategy or technology; it is the missing workforce qualification step every other regulated capability requires.
The future of compliant AI is not better content generation. It is better control over what happens next.
A warning letter, a hard look at why “a human reviews it” does not settle the issue, and one company’s argument that accuracy was never the real problem.
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