State-of-the-art Manufacturing Analytics
Process Manufacturing organizations need to maximize efficiency, product quality and yield while meeting regulatory requirements and reducing costs in production processes. But they struggle to leverage the abundance of data generated in process development, manufacturing and quality.
BIOVIA Discoverant is a validation-ready solution for data access, automated aggregation and contextualization, analysis and reporting. It supports Industry 4.0 strategies by optimizing processes, product quality and yield and collaboration, delivering products and therapeutics faster and at lower costs.
BIOVIA Discoverant provides a powerful environment for descriptive, diagnostic and predictive analysis as well as a large variety of plotting capabilities including:
BIOVIA Discoverant’s role-based Signal Monitoring Dashboard is a “traffic light" style dashboard with a flexible rule engine that enables high-level monitoring with drill-downs. You can configure your own rules that pull together process capability indexes, risk factors and alerts. Status is reflected by green, yellow or red colors and is based on individual or any weighted combination of summarized parameters. The system also provides warnings when a process may be going out of control. The dashboard supports review-by-exception for efficient Process and Product Monitoring (PPM).
BIOVIA Discoverant's interactive Process Genealogy Mapping visualizes all the points of splitting and pooling in the process stream. By clicking on the map, you can easily see all the input and output relationships in the process stream from the start to the end of the process for any unit operation. The mapping supports lot/batch traceability, helping to trace where defective raw materials enter the stream and to identify all affected batches. The system also isolates batches that need investigation when deviations are observed.
BIOVIA Discoverant has been developed for use in regulated environments. Unlike most analysis and visualization tools, you can use results from BIOVIA Discoverant to support critical process decisions without further validation. The system supports CSA. This is a set of activities performed to ensure that the software functions as intended. CSA replaces traditional Computer System Validation (CSV) with a risk-based approach focusing on the intended approach.
Validation
BIOVIA performs extensive testing on all of its products to develop, execute and document test scripts, protocols and product testing as required by FDA guidelines. As the core functionality of BIOVIA Discoverant is fully documented and tested by BIOVIA, only your product- and process-specific data models and data capture forms require validation on-site. To reduce your validation efforts, you can leverage BIOVIA’s Validation Kit. In addition to BIOVIA’s internal test documentation, this kit includes:
BIOVIA Discoverant's Paper Record Input Manager (PRIMR) provides an easy way to turn paper-based data into electronic information. The software allows compliant data entry (both single and double data entry and data reconciliation) with electronic signatures, template versioning, role-based access to functions and auditing to comply with 21 CFR Part 11 requirements. Flexible templates allow you to import standard HTML forms and then set up verification settings to minimize entry of "bad" data . After the entered data has been approved, it is exported to a separate database schema
The Cloud Exchange capabilities of BIOVIA Discoverant allow sponsors and CMOs to easily share and exchange data through the cloud. When both organizations utilize BIOVIA Discoverant, it is possible to automatically export Analysis Groups and push them into the cloud where they are available for automatic retrieval. In cases where one partner does not use BIOVIA Discoverant, the other can generate consistently formatted spreadsheets and push them into the cloud automatically, where they can be accessed in a controlled manner.
Learn how BIOVIA Discoverant can help support the Manufacturing Process Lifecycle:
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