PharmiWeb published a byline by Ramji Vasudevan, Head of Healthcare and Life Sciences at Altimetrik, titled“Pharma Races Ahead on AI, but Governance Struggles to Keep Pace.”
In the article, Ramji examines the growing gap between rapid AI adoption and the maturity of governance frameworks within pharmaceutical organisations. While AI is now embedded across R&D, clinical trials, and manufacturing, he highlights how risks such as model drift, data leakage, bias, and regulatory non-compliance are exposing operational vulnerabilities that legacy quality systems were never designed to manage.
Drawing on evolving regulatory guidance from the FDA, EMA, and ICH, Ramji emphasizes the need for observable, auditable, and accountable AI systems particularly as agentic AI begins to execute workflows autonomously. He argues that companies that treat AI governance as an operational discipline, rather than an administrative burden, will scale innovation faster while protecting patient safety, data integrity, and trust.
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