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PharmTech.com Quality and Regulatory Sourcebook March eBook 2023 Pharmaceutical Technology ® 21 Qualit y Control the supply chain, ensuring that they meet the required standards at every stage of production. Intelligent informatics can also support the compli- ance audit trail with a complete record of all activities and decisions. This support may include documentation of training and qualifications of personnel, as well as records of procedures, protocols, and standard operat- ing procedures (SOPs). In addition, the compliance audit trail can include records of all equipment, software, ma- terials, and reagents used in the laboratory, as well as re- cords of equipment maintenance and calibration. Other important components include records of all data and results obtained, as well as any deviations from stan- dard procedures and any corrective actions taken. Impact in the QC laboratory Intelligent informatics can be used to automate many of the tedious and error-prone tasks involved in drug development and production. Improved usability of AI-powered software can help reduce the risk of errors and can make testing easier and more accessible than before. This improvement in accessibility can help re- duce the likelihood of errors occurring during these processes, as well as improve efficiency and speed. The long-term value of intelligent informatics lies in the ability of scientists to use their time effectively to collect data by removing time-consuming manual tasks and allowing them to make better and faster business decisions (4). The goal is not instrumentation that thinks for itself, but technology that is intelligent enough to help humans do their jobs better and faster. This capability generates productivity gains and im- proves efficiency in the lab, while also allowing sci- entists to spend more time on value-added tasks such as method development and validation, data analysis, and data interpretation. System errors and checks. Smart technology in combination with instrumentation could f lag poten- tial issues or errors, which may result in a failed sam- ple analysis and lost productivity, before the analyst starts an analytical run. The goal is to prevent com- mon errors such as insufficient solvent to complete the run, use of the incorrect mobile phase or column, or selection of the incorrect method for a particular sample. This capability is important as laboratories hire more employees without extensive experience operating specific instrumentation or troubleshoot- ing issues. Algorithms can also support checks for infrequent or uncommon errors that require more advanced knowledge. Additionally, all data would be logged to learn about errors and even predict future ones before they occur. Lab management efficiency. AI-powered intelligent informatics offer opportunities to minimize wasted time for troubleshooting, training, data analysis, and other activities that can take time out of the working day. High-performance Raman systems for a range of applications in any field There's a reason scientists and engineers choose Renishaw Raman solutions. For decades, we have developed the products and technologies that generate the best results. Explore Renishaw's suite of Raman instruments: microscopes, portable analyzers, and imaging systems. Perform both quantitative and qualitative molecular analysis on even the most challenging samples. Renishaw, Inc. West Dundee, IL 60118 © 2023 Renishaw, Inc. All rights reserved. usa@renishaw.com inLux ™ SEM Raman interface Virsa ™ Raman analyser and fiber-optic probe RA816 Biological analyser inVia ™ Raman microscope RA802 Pharmaceutical analyser www.renishaw.com/raman RamanGeneralAd 2 PharmTech3_23.indd 1 RamanGeneralAd 2 PharmTech3_23.indd 1 2/16/23 9:16 AM 2/16/23 9:16 AM