Best Practices For Effective Quality Documentation Processes In Drug Manufacturing

By Alok Tayi, Ph.D.

Drug development has gone through a lot of change over the past decade. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. There is always a balance between speed and compliance, while others 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 the trends that successful Quality & Compliance teams adopt to keep pace with the speed of discovery.