One way of accelerating the production chain is by digitalising technology transfer, which is the iterative process of moving product data through each stage of drug development, from research to testing, licensing and commercialisation.
Transferring the huge volumes of data required is far from straightforward and each step presents a risk of violations that could delay or inhibit the development of new drugs. Historically, it has been difficult to perform technology transfer because the information is contained in different spreadsheets, word documents and other records.
As a result, the process has been time-consuming and required significant manual effort. Another problem has been that each stage of technology transfer is typically handled independently – with differing employees, processes, equipment, needs and locations. As a result, the process has traditionally been inefficient and prone to errors and delays.
By employing comprehensive process knowledge management techniques, organisations can transform how they perform technology transfers, and therefore move faster from research and development to production. Process and Knowledge Management (PKM™) software helps by seamlessly managing product and process specifications throughout the drug development lifecycle. PKM software creates an electronic repository to capture every decision made across product development.
Automated integration with other key manufacturing systems, including the manufacturing execution system (MES) and distributed control system (DCS), enables the conversion of a traditionally paper-based process of technology transfer into an electronic work activity, with data seamlessly transferred between systems.
In a webinar on July 11, Emerson will explain how its (PKM) software provides a structured repository and collaboration model for recipes during the development process. Attendees will learn how this web-based application seamlessly manages both product and process specifications and enables global sites, cross-functional teams and contract manufacturing organisations to work together to scale recipes and execute technology transfers.
