Rubrik: GxP
(Treffer aus pharmind, Nr. 10, Seite 924 (2025))
Schiel C | Zischka F | Erdmann N
Human-in-the-Loop in AI-driven Processes / Why people matter more – not less – in the AI-powered life sciences industry · Schiel C, Zischka F, Erdmann N · Deloitte
Artificial Intelligence Annex 22 Compliance Human-in-the-loop Automation AI is now part of everyday processes. In both Pharma and MedTech, AI is being introduced into non-GxP and even into core GxP functions with increasing speed and confidence. Consequently, people are beginning to supervise, verify, and take ownership of work initiated by AI – often without realizing their roles have shifted. Let’s explore how this shift is unfolding in practice: Traditionally, in pharmacovigilance, safety specialists manually reviewed thousands of articles to identify adverse event mentions and assess case validity. Today, many companies are using AI tools to pre-screen literature databases, flag relevant articles, ...