GxP Validation In The Age Of Technology Disruption

By Alok Tayi, PhD

Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since been overrun by computerized systems, cloud software, and artificial intelligence. In this dynamic technological environment, many biopharma struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. Needless to say, developing a quality and compliance posture that meets the needs of both masters (business stakeholders v. auditors) is a tall order. In this piece, we will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.