Artificial intelligence (AI) rapidly transforms the biopharmaceutical industry, offering unprecedented opportunities to enhance efficiency, accuracy, and innovation. However, as AI becomes increasingly integrated into GMP-regulated processes, traditional quality management approaches must be rethought. This article delves into the critical aspects of GMP quality compliance in the AI era. It explores the top five reasons why
What should we expect from Validation 4.0 Validation by design a.k.a Validation 4.0 is a new approach to validation in the biopharmaceutical industry that is designed to be more efficient, effective, and compliant with regulatory requirements. It is based on the principles of risk-based thinking, quality by design, and data integrity by design. Key
Industry 4.0 refers to the fourth Industrial Revolution through the use of cyber-physical systems. It consists of using the digital technologies to make manufacturing more agile, flexible and responsive to customers. Industry 4.0 digitizes and integrates processes vertically across the entire organization, from product development and purchasing, through manufacturing, logistics and service. All data about