Continuous real-time quality control and assurance is highly desirable in biopharmaceutical production, and can be achieved with sophisticated process management strategies that use multivariate monitoring techniques to prevent or reduce the risk of producing poor quality products. Multivariate monitoring is based on models that represent the relationship between parameters, while traditional process monitoring is based on univariate rules that do not have the ability to detect correlation patterns and result in erroneous conclusions.
SIMCA®-online is software for multivariate monitoring of statistical processes in real time and control of previously established Design Spaces based on current process parameters and (spectro) analytical data. The software enables early detection of process deviations and provides user instructions for identifying potential causes by displaying easy-to-understand graphics. In addition to resulting in improved health, safety and environmental performance, it also increases control and assurance of the entire process and product quality.