BIOVIA provides a Manufacturing Informatics solution experience which integrates process development, manufacturing and quality environments to drive effective process design, performance and improvement.
The BIOVIA solution for Manufacturing Informatics supports three major areas that empower production operations shorten time to market and maximize profitability:
Improve Process Design to understand the critical process drivers parameters
Increase Process Performance by monitoring variability enabling preemptive action
Enhance Process Improvement by understanding and control process and product variability
The BIOVIA solution for Process Design, Performance and Improvement is a validation-ready system for process and quality data access, aggregation, contextualization, analysis and reporting. The system shortens time to market and maximizes profitability by enabling design of robust GMP processes and immediate visibility into process performance, quality and compliance risk, as well as improved understanding and control process and product variability.
Capabilities include:
Automated data queries, analysis and visualizations
Graphical display of process genealogy for lot traceability
Capture of paper-based data in a Part 11 compliant way
Ad hoc investigational analysis using all types of process and quality data
Improved process understanding for control of variability
Automated trending and alerts (CPV) with role-based Signal Monitoring Dashboards for visibility across in-house and contractor manufacturing networks
Stability analysis with automated Out-of-Trend (OOT) alerts
Analysis of on-line and off-line multi-phase cell culture and chromatography data