An enterprise level, validation-ready system for process and quality data access, aggregation, contextualisation, analysis and reporting

BIOVIA Discoverant is an enterprise level, validation-ready system for process and quality data access, aggregation, contextualisation, analysis and reporting. The system shortens time to market and maximises 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 of process and product variability.

Capabilities include:

• Aggregation and contextualisation of data from different sources
• Capture of paper record data in compliance with 21 CFR Part 11
• Self-service on-demand ad-hoc data queries, analysis and visualisations
• Real-time monitoring of variability with automated alerts for review-by-exception
• Automated trending and alerts for Continued Process Verification (CPV)
• Role-based Signal Monitoring Dashboards for process performance 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
• Automated periodic reporting (Batch, Investigation, APRs, etc.)
• Genealogy Map for interactive graphical genealogy reporting allowing upstream/downstream traceability (lot traceability) from a selected batch
• Proportional genealogy analysis using weighted averages based on contribution amounts of raw materials and pooled steps during the manufacturing process

Watch the 4-part video series showing how BIOVIA Discoverant improves process design, increases process performance and enhances process improvement.

Benefits

• Access to all process and quality data with automated data contextualisation
• Gain better process understanding by ad-hoc analysis of data
• Obtain visibility into process performance at all levels in the organisation
• Perform upstream / downstream correlations across pooling and splitting points in the process stream
• Make GMP decisions for deviation investigations and batch dispositioning
• Make golden batch comparisons
• Collaborate to create and share process knowledge regardless of organisational or geographic barriers
• Leverage the value of investments in existing data infrastructure

BIOVA Discoverant minimises non-value-added manual tasks, reduces the risk of errors, and promotes process understanding and knowledge sharing to reduce process variability. Ultimately BIOVIA Discoverant helps speed time to market and improve process economics and sustainability.

What's New in BIOVIA Discoverant 2017?

Analysing the effect of raw material characteristics on process outcomes

• Determine which characteristics contribute to positive operations trends
• Proactively route raw materials to the processes where they will contribute most
• Target resources to operations areas most in need

Determining expiration dates for products that degrade in a non-linear fashion

• Understand stability study data that follows quadratic and cubic models
• Identify sources for process improvements that lead to longer shelf life

Next-generation Monitoring-by-Exception of quality assay results to minimise non-value added tasks

• Assess results using both summary statistics and individual test results
• Make pro-active process adjustments to avoid costly failures
• Focus efforts where they add the most value