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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 9 process and analytical equipment, according to Seaver. "This information can be linked to the purpose of the study in electronic laboratory notebooks to provide the context. It has also made it possible to compare infor- mation across studies, multiple projects/molecules, and scales to better understand risk," he says. The popularity of coding languages (like the preva- lence of Python for not only data science but pro- gramming in general) and technologies, such as the Industrial Internet-of-Things, has also led to amazing innovation in the areas of therapeutic development lifecycle data processing, adds Andrews. "The ad- vance of communication and encryption technologies mean data provenance and non-repudiation are more reliable. Above all, a common data platform used by multiple business units and across manufacturing net- works provides these types of high-quality operational experiences," he explains. There are also many cutting-edge technologies coming down the pike that will change the way pro- cess monitoring and analytical data are managed, ac- cording to Andrews. "Companies in all industries are seeing the benefit of mining their vast stores of data. Using machine learning methods like those employed in Dassault Systèmes BIOVIA's Generative Therapeu- tics Design dramatically reduces the risks and costs in new drug discovery," Andrews notes. The same types of savings are being seen in integration of R&D, pro- cess development, manufacturing, and quality data, he adds. This digital continuity can accelerate healthcare innovation in a transformative way, Andrews claims. Risk management and predictive tools will le- verage and track historical and process-specific knowledge over the course of the development lifecycle to allow for a risk-based approach to study design and improved efficiency during develop- ment, concludes Seaver. Reference 1. ISPE, ISPE GAMP 5 Guide: A Risk-Based Approach to Compli- ant GxP Computerized Systems, February 2008. PT As bio/pharma companies seek more automated processes, suppliers are introducing new technologies to enhance data collection, process control, and remote monitoring. Visualizing the manufacturing process MilliporeSigma has introduced the Bio4C Software Suite, which combines process control, analytics, and plant-level automation to enable users to look across the entire manufacturing process, rather than individual operational units. In a press statement announcing the software (1), the company noted the importance of the integration of software, automation, and analytics into biomanufacturing facilities' operations to intensify biologic production. Part of the company's BioContinuum Platform, the software suite was designed based on a 4C strategy—control, connect, collect, and collaborate— to make digital connections between different process steps, give visibility to the entire process, gather data into one place, maintain and validate the integrity of that data. Bio4C ProcessPad, part of the "collect" dimension of the Bio4C Suite, is a browser-based platform that allows users to acquire, aggregate, and analyze data from equipment, batch records, databases, and historians across the bioprocess. The company says it will roll out further Bio4C Software Suite products and modules throughout 2020 and beyond. Monitoring processes remotely Augury, which supplies artificial intelligence-based machine solutions, has announced new capabilities for remote monitoring and diagnosis of manufacturing equipment, including pharmaceutical manufacturing (2). Augury Threads allows maintenance teams, reliability experts, and operations teams to share analytics, insights, recommendations, and actions about machines from anywhere in the world. Other features include remote diagnostics and anomaly-based alerts with deeper root-cause analysis and prescriptive maintenance recommendations. The platform offers a remote view of machine history that can be combined with the Threads feature as a single place to track the history of a machine's performance and the expert reliability conversations around it. The company is also providing increased support for remote on-boarding of new personnel and machines. References 1. MilliporeSigma, "MilliporeSigma Accelerates Readiness of Bio- processing Facility of the Future," Press Release, April 30, 2020. 2. Augury, "Augury Delivers New Features and Services to Keep Machines and People Healthier and More Productive in Critical Industrial Facilities," Press Release, May 6, 2020. —The editors of Pharmaceutical Technology Data management and artificial intelligence advance process controls