The days of maintaining paper records across the life sciences development and production pipeline are gone. Today’s regulatory requirements, not to mention the complexity of new treatments, requires organization that can only be provided electronically. However, while many life sciences teams have moved to electronic records software, many teams are still inadvertently creating data silos—both horizontally across business areas and vertically between development and manufacturing—that slow technology transfer dramatically. Emerson’s Kristel Biehler elaborates in her recent article in the International Society of Automation’s InTech, explaining,
“In the worst case, critical data stored on paper and in spreadsheets is difficult to move from stage to stage, and it is subject to loss and error. Records, recipes, and other critical data must be reorganized at each stage—a time-consuming and frustrating task, and one prone to error. But even in the best case, different groups along the production pipeline typically use different software packages, different databases, and even different production scale and language, which slows the transmission of data from one stage of development to the next.”
Breaking down the barriers
A new technology is helping life sciences teams eliminate the silos that impede fast treatment development. Forward-thinking manufacturers are employing Process and Knowledge Management™ (PKM) software to help teams share information more easily.
PKM software captures every decision made across the drug development pipeline in an electronic repository. All data is automatically collated and centralized for easy access by any authorized user across the organization. Whether data is recorded in the early stages of research and development or in the latest stages of full-scale manufacturing, it is available for review to help teams generate insights and make better decisions.
Integration provides expediency
The best PKM solutions, Kristel explains, are also integrated with another key technology for speeding the development pipeline: the manufacturing execution system (MES). In fact, easily integrated systems can dramatically cut production timelines for new treatments. Kristel explains,
“Fit-for-purpose PKM solutions make it easier to transfer master recipes. The recipe repository is directly linked to the MES, eliminating the need for conversion or for custom—and fragile—connectivity between the two systems. The PKM system can seamlessly push parameters and sequence of operation to the MES, helping teams better manage inventory, while providing improved visibility of manufacturing guidelines. Experts estimate this type of connectivity can help reduce time to market from 10 years to fewer than three. “
In addition, modern MES solutions like Emerson’s Syncade offer standardized batch records, efficient exception management, improved consistency, and facility-wide equipment management to help teams build automated, reliable, and repeatable workflows to better manage procedures, equipment, materials, and quality across the production pipeline.
To learn more about how Emerson’s PKM and MES software help life sciences teams speed time to market, you can read Kristel’s article in its entirety at InTech.