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Kossi Molley (he/il)
Understanding and navigating the complexities of these frameworks is essential for organizations seeking efficiency, innovation, and regulatory alignment.
By -
Kossi Molley (he/il)
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
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Kossi Molley (he/il)
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
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Kossi Molley (he/il)
Computerized System Assurance (CSA) is a modern approach to validating automated systems, particularly in the life sciences industry. It emphasizes a risk-based methodology, focusing on product quality and patient safety, rather than the traditional, more burdensome Computer System Validation (CSV) approach [1], [2]. This article delves into the intricacies of CSA, highlighting the dos and