Review on Cloud-Based Computer System Validation: Challenges and Strategies for GxP Compliance

Cloud-based technologies are being used increasingly by the pharmaceutical industry to support vital functions like manufacturing, quality control, research, and regulatory compliance. There are significant advantages to this change in terms of global collaboration, cost effectiveness, and scalability. However, it poses new difficulties for Computer System Validation (CSV) following regulatory frameworks like GAMP 5(2nd Edition), FDA 21 CFR Part 11, and EU Annex 11. The dynamic and shared environments of cloud services like SaaS, PaaS, and IaaS frequently make traditional CSV approaches inadequate. These methods have been developed for on-premises systems. The current regulatory requirements to evaluate cloud-based GxP systems are addressed in this review, which also indicates important gaps such as the lack of cloud-specific validation methods, difficulty keeping track of cloud vendor updates, and challenges validating AI/ML-driven tools. It also discusses data integrity, audit trails, access controls, and supplier oversight as key validation priorities. To help regulated companies remain compliant, the paper recommends a hybrid validation approach. This combines the structured V-Model for high-risk modules with agile validation for cloud-native and rapidly changing components. It also provides classification criteria for cloud applications based on their function, GxP impact, and deployment model. By aligning validation practices with modern technologies and regulatory requirements, in summary, this paper offers a practical framework for pharmaceutical companies. It helps align cloud use with regulatory requirements, supporting digital innovation while ensuring GxP compliance, patient safety, and audit readiness.