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By - Kossi Molley (he/il)

Optimizing Operational Excellence in Biopharma

The biopharmaceutical industry stands at the intersection of groundbreaking innovation and stringent regulatory compliance. With the constant push for accelerated timelines, cost efficiency, and high-quality outcomes, operational excellence has become a cornerstone for success in biopharma. But how can companies optimize their operational practices to stay ahead in this competitive landscape? This article explores key

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By - Kossi Molley (he/il)

Predictive Analytics for Determining Non-Conformities in Pharmaceuticals

Predictive analytics applied to determining non-conformities in the pharmaceutical industry represents a significant advancement in ensuring product quality and safety. Here’s a detailed analysis of this field: 1. Importance of Predictive Analytics in Pharmaceuticals 2. Predictive Analytics Methods 3. Specific Applications 4. Challenges and Considerations In conclusion, predictive analytics offers significant potential to improve quality,

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By - Kossi Molley (he/il)

Rethinking Quality Processes in the AI Environment

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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By - Kossi Molley (he/il)

Applying Computerized System Assurance (CSA) to Legacy Systems

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

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By - Kossi Molley (he/il)

Addressing Drug Shortages with AI and ML

The use of artificial intelligence and machine learning in the pharmaceutical industry holds immense promise for overcoming drug shortages. By leveraging predictive analytics, real-time demand forecasting, quality control, regulatory compliance, inventory management, and early warning systems, AI and ML can help ensure that patients have reliable access to the medications they need.

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