Discoverant integrates powerful investigational analytics together with a unique data connectivity technology to provide real-time on-demand data access, collaborative analysis of manufacturing and process development data and reporting. Using a patented data and process modeling capability, Discoverant maps and maintains the data-type and batch relationships in the data from existing systems — including e.g. LIMS, SCADA, EBR/MES, ERP and even data from paper records — delivering a complete environment for better understanding and controlling the sources of variability in the process, all the way from raw materials to finished product.
Discoverant is a validatable software system that allows process development and manufacturing to collaborate more effectively regardless of geography, speeding time to value for new products, and improving process stability and predictability for existing products.
Hierarchical Views for On-demand Data Access
Provides a logical user-centric context for data access showing unit operations, equipment, instruments and parameters without regard to where they are physically located. Eliminates the need for end users to program or write SQL queries to access the data. The data is laid out just the way it is collected during the process itself. Organizes data in dynamic structures with nodes that can be expanded with point-and-click ease and simple navigation tools.
Table View
Provides capabilities for detailed review, editing and creation of individual data elements of all data types. Also provides ways to condition data so that outliers and missing data are handled properly in subsequent analyses. Users can also group data into useful categories for statistical or graphical comparisons.
Statistical Capabilities
Provides basic and advanced Univariate and multivariate statistical tools to help users easily identify and analyze everyday process data. For example, users can use Two-Sample t-tests to compare the average of two groups and find out if they are significantly different. Principal Component Analysis (PCA) can be used to transform a large data set with a large number of correlated variables, into a much smaller set of uncorrelated variables. These variables can be used for additional types of analyses within Discoverant.
Plotting Capabilities
Provides quick and easy ways to compare data graphically. Discoverant can plot either single or multiple parameters displayed in one or multiple panels, based on one or more batches or groups of batches. Summarization functions are enhanced to assist users in understanding the historical data. An easy point-and-click “overlay” function is also provided to allow users to overlay the current batch in real-time, onto the historical batches and assess performance.
Quality Monitor
Provides Statistical Process Control (SPC) and other capabilities to assist users in understanding their process and promote visibility throughout the team. Using a variety of types of control charts, users can plot and monitor a process and visually determine when the process falls outside of pre-determined limits, including multiple limits in the same chart. Process Capability functionality helps users to set and monitor specifications.
Stability Studies and Expiration Dating (SED)
Provides capabilities to conduct stability studies and accelerated stability studies, using plots of stability indicating parameters at specific time points and continuously over time, for single lots or several groups of lots under several study conditions. Also provides the ability to prepare stability summary reports formatted for submissions. Users can also use built-in statistical tests to automatically calculate expiration dates and determine whether individual lots or groups of lots can be assigned the same expiration date.
Curve Metrics®
Provides users with all the point-and-click tools needed to work comprehensively with continuous data, to extract features on-screen, quantify them, combine them with other discrete data and use them for quantitative analysis. With Advanced Profile Analysis (APA), users can analyze several different time series parameters at once, to see which of them in combination are the best predictors of the process outcome.
Visual Process Signatures® (VPS)
Provides animated visualizations of the parameter interactions among batches, over time or in relation to the value of a selected process parameter. VPS is an excellent way to learn more about the behaviour otherwise hidden parameter relationships in the manufacturing process and how to improve control. By providing an overview of the parameter interactions, the VPS visualizations can identify parameters that warrant further analysis.
Multi Phase Analysis (MPA)
Provides ways to examine chromatography and other multi-phase data in a completely new way. MPA allows automatic or point-and-click identification of the phases of chromatographic and other continuous data. Once phases are identified, they can be visually and quantitatively compared individually or in groups. MPA can be used to more accurately determine the lifetime of costly chromatography resins, to avoid premature replacement of resins and to minimize the risk of harmful impurities entering the product stream.
Paper Record Input Manager (PRIMR)
Provides an efficient, FDA (21 CFR Part 11) compliant and secure way to capture the data from paper records and make it easily available in electronic form without the cost and burden of an EBR implementation. PRIMR creates an on-screen replica of the paper record in which the data entry fields are tied to the data access view. Built-in capabilities include password-controlled user access, double entry and automatic crosschecking, password-controlled data review, reconciliation and approval, and all the other requirements for Part 11 compliance.
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