AI is entering GxP-regulated environments—but simple answers are proving elusive. As guidance evolves and the technology advances rapidly, organizations face critical questions: how much control is enough, and what does enough control look like? This blog post challenges “catch-all” thinking and makes the case for a contextual, life cycle-focused approach to AI controls, prioritizing judgment,...
Artificial intelligence (AI) is transforming how GxP-regulated areas of life sciences operate. As AI grows ever more capable, people are rethinking humans’ role in an increasingly technology- and data-driven world. With key competencies of AI literacy and data understanding being of paramount importance, strong critical thinking skills become ever more essential for effective oversight.
By adopting artificial intelligence (AI) and machine learning (ML), the life sciences industry can leverage dynamic systems, a completely new system design. These systems feature ML models that learn adaptively automatically from data, accommodating changing relationships between input and output over time.
The new ISPE GAMP® Guide: Artificial Intelligence provides a comprehensive, state-of-the-art best practice framework to efficiently and effectively achieve high-quality AI-enabled...
Informed consent aims to provide clinical trial participants with transparent education about the trial’s objectives, potential risks and benefits, and procedural requirements. As clinical trial designs evolve to include decentralized and adaptive elements, the informed consent process becomes increasingly complex. In response, this article explores the potential application of AI-powered...
