By BioPhorum
Published in: Cell and Gene Newsletter
Published on: November 17, 2025
Managing deviations within the biopharmaceutical industry is a critical process to ensure product quality, regulatory compliance, and, ultimately, patient safety. Today, deviation management between sponsors and contract manufacturing organizations (CMOs) is heavily manual, complex, and fragmented, leading to inefficiencies, data integrity risks, and delayed resolutions. These challenges are exacerbated by inconsistent quality agreements, varying data standards, and the burden of manual data entry across disparate quality systems.
Recognizing these inefficiencies, this article presents a vision for digital deviation management — a standardized, digital-first approach to deviation reporting, data exchange, and resolution. By adopting digital strategies and standardized data models, organizations can significantly reduce manual processing, improve the accuracy and timeliness of information sharing, and strengthen trust between sponsors and CMOs.
This article outlines a clear framework for how the industry can move forward, including the definition of digital deviations, the key benefits of digitalization, and practical considerations such as data transmission alignment, validation requirements, and the use of industry-standard fields and controlled vocabularies.
