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www.biopharminternational.com Manufacturing and Facilities 2022 eBook BioPharm International ® 9 FIGURE COURTESY OF THE AUTHOR Automation In such disconnected facilities, pulling, reviewing, and analyzing data requires manual, error-prone tran- scription between systems, and software used to store data may not be properly connected and integrated across sites and facilities. As a result, even once data are transcribed into digital systems, they may not be accessible or legible to those who need them. Cumbersome, logistically complex data manage- ment makes critical tasks such as ensuring regulatory compliance more taxing. Trending and analysing data can also become so resource-intensive that identifying opportunities for process improvement may no longer be cost effective. Most importantly, though, without f lowing, high quality data, the full potential of the technologies that define Pharma 4.0 can't be fully un- locked. Unfortunately, these difficulties multiply as companies scale up and the volume and complexity of data increases. Setting up strong: putting digital maturity first Facing the challenges of a disconnected lab, the phar- maceutical sector is realizing the importance of a digi- tal maturity-first approach to Pharma 4.0. Digital ma- turity describes how much of a company's data are in digital systems, the level of connectivity between those systems, and how easy it is to retrieve that data. When fully digitally mature, manufacturing plants have all their data digitally stored, available, and accessible to all sites and stakeholders. Seeking digital maturity first offers several benefits for pharmaceutical manufacturers. First, it helps orga- nizations more easily extract and analyze their existing data. Not only does this streamline regulatory compli- ance and reduce workload, but it also means manufac- turers can better capitalize on their data—for example, by evaluating the health of their systems in real-time, more clearly identifying process bottle necks, and an- ticipating issues for preventative action. As well as offering near-immediate benefits, prior- itizing digital maturity early can optimally position companies for adding, and getting the most out of, more sophisticated control, automation, and analytics tech- nologies in future. For example, with comprehensive, high-quality data flowing seamlessly between systems, more accurate and valuable insights can be generated from machine learning and AI-powered analytics. The modern, flexible LIMS: a cornerstone of digital maturity Advanced laboratory information management systems (LIMS) play a critical role in enabling digital maturity, acting as the digital backbone of the entire pharmaceuti- cal value chain. For pharmaceutical manufacturing spe- cifically, LIMS can help digitalize the full quality assur- ance (QA) and quality control (QC) workflow (Figure 1), with capabilities for stability testing and environmental monitoring management, as well as media management for biopharmaceutical applications. By integrating with and connecting other systems and equipment in the manufacturing process, mod- ern LIMS help to bring data together, at scale, and in a meaningful, organized, and secure way. And, by act- ing as a single point of access across systems and sites, LIMS make data retrieval and sharing simpler and faster. LIMS also enhance and maintain data integrity by eliminating manual processes across data collection, sharing, and analysis, and by ensuring data are accessi- ble only to authorized users. To ensure LIMS that are deployed today continue to serve the digital maturity needs of the future, some pro- viders are putting flexibility and scalability at the core of LIMS design. For example, the most advanced LIMS FIGURE 1. Advanced laboratory information management systems (LIMS) help digitalize operations across the entire pharma manufacturing quality assurance/ quality control (QA/QC) workflow.