This paper explores the application of artificial intelligence in quality assurance and regulatory affairs across the life sciences industry. It outlines how AI can enhance efficiency, consistency, and insight generation in areas such as submissions, post-market surveillance, and compliance monitoring. The report also addresses regulatory, ethical, and governance challenges, emphasizing the need for robust oversight and data integrity. Through expert perspectives, it highlights why readiness varies across organizations and why regulatory compliance remains the primary concern. The paper positions AI as a strategic enabler when deployed responsibly within regulated environments.

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