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Regulatory compliance in the pharmaceutical industry is challenging, requiring dedicated resources and meticulous control over production processes to ensure adherence to established regulatory guidelines, specifically ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) principles. This paper introduces an innovative approach to assess pharma regulatory compliance, utilizing a network model of the production process. The model dynamically configures production line characteristics based on manufacturing process data, overcoming complexity and scalability challenges.

The main purpose is to address the challenges of regulatory compliance in the pharmaceutical industry by introducing a novel approach using a network model. The research question involves assessing the effectiveness of this model in ensuring compliance with …