Managing Process Knowledge Throughout Drug Development And Manufacturing

By Sumeet Dalvi, Emerson

Digital transformation is reshaping how life sciences organizations bring therapies to market—accelerating timelines and improving consistency across development and manufacturing. By centralizing and standardizing product and process data, teams can streamline technology transfers, reduce manual effort, and ensure regulatory compliance. Tools like DeltaV™ Process Specification Management (PSM) and Process Risk Assessment (PRA) enable scientists to manage complex specifications, automate calculations, and conduct robust risk assessments with greater efficiency. These systems integrate seamlessly with lab and production platforms to allow for faster data exchange and reduce transfer timelines by up to a year. With embedded change control and centralized access to critical parameters, teams can maintain data integrity and simplify GxP compliance.

For organizations navigating the complexities of drug development, find out how adopting a digitalized recipe management system offers a clear path to speed, accuracy, and scalability.