Process Production Operations

Empowering production operations in process industries to shorten time to market and maximize profitability by leveraging process and quality data

Product and Process Monitoring

The FDA Validation Guidelines expect Life Science manufacturers and Contract Manufacturing Organizations (CMOs) to look more closely at routine process and product monitoring for every batch. By providing operating staff with warnings so they can take action before batches begin to fail, a monitoring-by-exception system with routine process trending and automated alarms can decrease production costs and delays by reducing process variability, minimizing inventory and improving process yield and quality outcomes.

The BIOVIA solution for Process and Product Monitoring (PPM) is a purpose-built, easily validated environment for real-time process and product monitoring including 21 CFR Part 11-compliant capture and centralized management of paper-based data. Industry-specific capabilities include:

  • Process trending for early warning of out-of-control conditions
  • Automatic updates and email alerts for monitoring by exception so that effort can be focused where it is needed most
  • Labeling and tracking of Critical Process Parameters and Critical Quality Attributes
  • Tri-panel plot with CUSUM plot for root cause analysis
  • Process capability analysis to determine whether a process meets specifications and to identify variability within critical parameters
  • 17 unique single and combination control charts including Variable and Attribute charts and assumption tests
  • Real-time, browser-based updates
  • High-level batch reports indicating whether parameters passed or failed specification
  • Automatic calculation of summary statistics for time series and other data types

BIOVIA’s state-of-the-art solution provides a single software environment that includes additional investigational capabilities supporting the next phase of process and product monitoring including:

  • Ad hoc cause-and-effect analytics and reporting to investigate adverse or favorable trends and identify process improvement opportunities
  • Feature Extraction capabilities to isolate specific process features and include complex continuous process and quality parameters in a monitoring program along with their interactions
  • Product stability monitoring and expiration dating capabilities that can be used to correlate stability outcomes with upstream process conditions
  • A wide range of additional univariate and multivariate analytics and reporting capabilities

BIOVIA Industry-specific consulting support includes assistance with:

  • Development of process and product monitoring guidelines and protocols
  • Parameter identification, risk assessments and sampling protocols
  • Organization and configuration of process and product monitoring-by-exception systems
  • Interpretation of monitoring results and recommendations for follow-on actions
  • Training on process and product monitoring analytics
  • General statistical guidance and software solution training
  • Periodic program reviews with recommendations for improvements
Learn More About Signal Monitoring Dashboards

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