AI-Driven Computer System Validation for Next-Gen GxP Compliance
DOI:
https://doi.org/10.22399/ijcesen.4368Keywords:
Artificial Intelligence, Computer System Validation, GxP Compliance, Machine Learning, Continuous ValidationAbstract
As the field of artificial intelligence (AI) quickly infiltrates the life sciences and pharmaceutical industry, its disruptive quality in Good x Practice (GxP) compliance is increasingly becoming a plausible development particularly in the area of Computer System Validation (CSV). The traditional validation procedures that are rather inert, paper-based, and manual were not applicable in the world of agile development cycles, SaaS applications, and continuous system improvement. AI-Based CSV offers real-time risk evaluation, dynamic, intelligent automation, which is more efficient, precise, and in line with the regulations. The paper will look at the history of validation practices, the role of AI technologies, machine learning, and natural language processing, and the regulatory framework that is shifting to accommodate such a shift. It further examines these concerns as model explainability, data integrity, cybersecurity, and lifecycle governance, and offers a strategic outlook of AI as an initial tool for ensuring a continual validation. The paper also outlines the importance of AI in the next-generation GxP compliance and ensures data integrity in a more digitised regulatory environment in depth.
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