Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. In this dynamic environment, many biopharma companies 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 and 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.