Redefining Quality in Cell and Gene Therapies: Lessons from Implementing Electronic QMS in Academic cGMP Facility.

Manufacturing cell and gene therapies (CGTs) involves complex processes that require robust quality management, especially within academic current Good Manufacturing Practice (cGMP) facilities, where resources are often limited. Traditional paper-based quality management systems (QMS), while initially convenient, often become burdensome, leading to errors, poor traceability, and compliance risks. Electronic Quality Management Systems (eQMS) are gaining recognition for their ability to centralize and automate key quality processes, significantly enhancing operational efficiency. Through an in-depth case study of the USC/CHLA academic cGMP facility, this review demonstrates tangible improvements achieved by adopting an eQMS. Practical insights gained from this experience are shared, including careful selection of eQMS platforms, phased rollout strategies, and comprehensive staff training. The review also addresses common implementation challenges and suggests practical solutions to overcome them. Lessons learned and strategies discussed here can serve as valuable guidance for other academic institutions considering eQMS adoption. Ultimately, adopting an eQMS equips academic CGT manufacturers to enhance sustainability, continuously optimize operations, and strengthen their strategic position within this rapidly evolving field.