AI Implementation To Enhance Quality

By Seongil Cho, Vice President of IT, Hyeokgeon Kwon, Director of Information Strategy, and Kisung Shim, Manager of Information Strategy

Generative AI (GenAI) is revolutionizing the biopharma industry, enhancing regulatory compliance, quality assurance, and operational efficiency. Samsung Biologics exemplifies how AI-driven solutions drive innovation while maintaining alignment with best practices.

Operating within a highly regulated environment, biopharmaceutical companies must adhere to stringent compliance standards to ensure product quality, safety, and efficacy. This includes the meticulous management of standard operating procedures (SOPs), deviations, corrective and preventive actions (CAPAs), and change control (CC) records. For contract development and manufacturing organizations (CDMOs), these demands are further intensified by client-specific requirements and frequent audits.

Traditional manual processes for managing compliance documentation are time-consuming and prone to inefficiencies. AI-driven platforms streamline these operations by enhancing inspection readiness, optimizing workflows, and mitigating risks. Beyond compliance, AI adoption leads to increased productivity, reduced costs, and improved service quality. As regulatory expectations evolve, AI offers a competitive edge by addressing critical operational challenges in biopharma.