Impact of GAMP 5 Guidelines on Validation of AI-Powered Medical Device Software

Abstract

The integration of artificial intelligence (AI) into medical device software has revolutionized healthcare by enhancing diagnostic accuracy, treatment efficiency, and patient outcomes. However, ensuring the reliability, safety, and regulatory compliance of AI-powered medical devices presents significant challenges. The Good Automated Manufacturing Practice (GAMP 5) guidelines provide a structured framework for validating automated systems, including AI-driven medical software. This study explores the impact of GAMP 5 guidelines on the validation process of AI-powered medical devices, addressing key aspects such as risk management, data integrity, and lifecycle management. Through a detailed analysis of regulatory requirements and case studies, this research highlights best practices for aligning AI-driven medical device validation with GAMP 5 principles. The findings underscore the importance of robust validation methodologies to ensure compliance, improve software performance, and enhance patient safety.