Digitizing Your Clinical Drug Development Process

By Kelly Stewart

Manufacturing execution systems (MES) are computerized systems used by manufacturers to review and record the transformation of raw materials to finished goods. They provide information that helps manufacturing decision makers fine-tune their process to adhere to the steps that ensure quality as well as optimization and production output.

MES works in real time to facilitate control of multiple elements of the production process, such as inputs, personnel, machines, and support services. MES software connects and controls manufacturing processes with enterprise systems such as ERP and PLM. As Gartner explains in their 2021 Magic Quadrant, MES software also gives “feedback on process performance, and support component and material-level traceability, genealogy and integration with process history, where required.”

In this white paper, we explore the adoption of digital manufacturing execution systems (MES) for clinical drug development. We review the usage of MES in pharmaceutical manufacturing. Walk through the entire drug production lifecycle, from preclinical to commercial, and zero in on what happens at the clinical stage. Learn why manufacturing execution systems are uniquely suited to clinical manufacturing.