BIOVIA Discoverant
State-of-the-art Manufacturing Analytics
Ensure Product Quality with 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.
Customers Report:
- 95% reduction in time for data aggregation
- 90% reduction in time taken to generate APRs
- 87% reduction in materials use during development
- Root cause investigation reduced from 1 month to 1 hour
- $35 Million/year reduction in batch deviations globally
Discoverant Capabilities
- Automated aggregation/contextualization of data from disparate sources
- Rapid data access for investigations and process improvement
- Large variety of data queries, analysis and visualizations
- Self-service data access for investigations and process improvement
- Ad hoc investigational analysis
- Automated Out-of-Trend (OOT) alerts (e.g., for stability analysis)
- Cloud-based data exchange between partners
- Role-based dashboards for visibility across the manufacturing network
- Automated creation of periodic reports (batch, investigation, APQR/APR/PQR, etc.)
- Graphical display of process genealogy for lot traceability
- FDA 21 CFR Part 11 compliant capture of paper-based data
Improve Regulatory Compliance
- Support CPV initiatives and significantly reduce efforts for regulatory reporting (APQR, PQR, …)
- Ensure data integrity for GMP-relevant decisions through automation
- Enhance GMP decisions for deviation investigations and batch dispositioning
- Deploy validation-ready solution and interfaces
Improve Product Quality and Yield
- Reduce variability and identify the root cause of OOS deviations
- Understand Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
- Improve data quality and decision-making through automation and integration
- Monitor, control and reduce process and product variability
Increase Productivity, Reduce Costs
- Automate data aggregation & contextualization
- Streamline regulatory reporting (batch, stability, shelf-life, CPV, APQRs) with automated data contextualization
- Digitalize and enhance Tech Transfer
- Optimize production parameters to reduce costs
- Avoid inefficiencies, deviations, scrap, recalls and problems
Collaborate Across the Supply Chain
- Control data exchange with partners (sponsor / CMO)
- Exchange data across the extended manufacturing network
- Provide visibility into process performance across the organization
- Access to all relevant data throughout the product and process lifecycle
Advanced Data Analysis
BIOVIA Discoverant provides a powerful environment for descriptive, diagnostic and predictive analysis as well as a large variety of plotting capabilities including:
- Process and product trending with alerts for early warning
- Event tri-panel root cause investigations for relating events to process shifts
- Correlation plot matrices for finding parameter relationships
- Process capability calculations
- Comparison of batches to understand process variations
- Univariate and multivariate statistical analysis
- Principal component analysis and regression
- General statistics
- Statistical process control monitoring and alerts
- Stability and expiration dating analysis using both linear and non-linear models
- Advanced profile analysis to find interactions between parameters
- Multi-phase analysis to analyze chromatography data
- Animated 3D visualizations to look for patterns in multivariate process data
- Complex multivariate problem solving through integration with Umetrics' SIMCA-P+
Signal Monitoring Dashboard
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).
Interactive Process Genealogy Mapping
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.
Computer Software Assurance
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:
- Validation plan template
- Installation qualification protocol
- Operational qualification protocols
- Comprehensive system requirements
- Executed Operational Qualification (OQ) and algorithm verification evidence
- System traceability matrix
Paper Records Conversion
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
Collaboration and Data Exchange
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.
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