Leveraging AI for Risk Management in Computer System Validation

Abstract

In Life Sciences, reliability and compliance of computerized systems is of utmost importance. These computerized systems play a critical role in maintaining product quality, patient safety, and data integrity. ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) provides a comprehensive framework for Computer System Validation (CSV) with an emphasis on a risk-based approach. With the rise of artificial intelligence (AI), there is a significant opportunity to enhance the effectiveness and efficiency of risk assessments in CSV. This article explores how AI can be leveraged to perform risk assessments in computer system validation, the benefits it offers, the challenges involved, and best practices for implementation.