Human-in-the-Loop (HITL) is frequently cited as a central control mechanism in AI-supported GxP processes: humans are expected to safeguard outputs generated within artificial intelligence (AI) supported GxP processes through review, approval, or override. However, findings from human factors research, organizational psychology, and the automation bias literature show that human oversight...
Digital transformation in the pharmaceutical industry is no longer a strategic ambition—it is an operational reality. Artificial intelligence (AI), cloud platforms, and data-driven automation are increasingly embedded in GxP-critical processes, from development and manufacturing to quality assurance and supply chain operations. While technology evolves rapidly, regulatory expectations around...
Due to the growing digitalization of the industry, we are highly dependent on information technology (IT) systems and data. The basic ability to execute our pharmaceutical business and decision-making processes relies on the permanent availability of these IT systems and data to ensure compliance and efficiency of our business operations. But numerous factors—including criminal activities,...
Real-world evidence (RWE) is clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery.
Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 5
