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A Framework for Cloud validation in Pharma

Journal of Computer and Communications 2024年第9期12卷 103-118页

作者： Pravin Ullagaddi Plaster School of Business University of the Cumberlands Williamsburg KY USA Pacific Biolabs Hercules CA USA

The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing.

关键词： computerized systems validation Risk-Based Approach Data Integrity Pharmaceutical Manufacturing Cloud validation

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