Automating FDA Compliance: The Role of AI in Computer System Validation (CSV)

Abstract

The increasing adoption of artificial intelligence (AI) in the pharmaceutical and healthcare industries has transformed regulatory compliance processes, particularly in Computer System Validation (CSV). The U.S. Food and Drug Administration (FDA) mandates strict compliance with CSV to ensure the reliability, accuracy, and integrity of computer systems used in drug development, manufacturing, and clinical trials. Traditional CSV methods are often time-consuming, labor-intensive, and prone to human error. AI-driven automation offers a solution by streamlining validation processes, reducing costs, and enhancing regulatory adherence. This paper explores the role of AI in automating CSV, highlighting its potential to improve efficiency, ensure data integrity, and minimize compliance risks. Additionally, it discusses the challenges and regulatory considerations associated with AI-driven CSV, providing insights into how organizations can leverage AI to meet FDA requirements effectively.