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 / Continued Process Verification

Improve process performance and compliance with Continued Process Verification (CPV)

The FDA Validation Guidelines expect Life Science manufacturers and Contract Manufacturing Organizations (CMOs) to look more closely at routine Process and Product Monitoring (PPM) for every batch and to validate their manufacturing processes. Continued Process Verification (CPV) is the third stage of the process validation for monitoring processes in a continued manner throughout the lifetime of the product to ensure the process remains in a state of control and meets the requirements set for the product, and to guarantee final product quality.

BIOVIA Discoverant, our solution for PPM and CPV is a purpose-built, validated environment for real-time process and product monitoring including 21 CFR Part 11-compliant capture and centralized management of paper-based data.

It helps organizations to understand the sources of process variation that impact the product, and undertake an initiative to introduce CPV. It provides better process and quality data access and analysis for improved operational reliability, along with wider collaboration and cost savings.

BIOVIA Discoverant provides 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 that can decrease production costs and delays by reducing process variability, minimizing inventory and improving process yield and quality outcomes.

Industry-specific capabilities include:

  • Process trending with run for early warning of out-of-control conditions
  • Automatic updates and email alerts for monitoring by exception
  • 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
  • 17 unique single and combination control charts including Variable and Attribute charts and assumption tests
  • Real-time, browser-based updates
  • Automatic calculation of summary statistics for time series and other data types
  • High-level batch reports indicating whether parameters passed or failed specification
  • Documentation of procedures decision points to reduce risk of over/under alerting
  • Reporting of data and findings through dashboards , quarterly reports and Annual Product Reports (APRs)
    Learn More About Signal Monitoring Dashboards
  • Additional investigational capabilities supporting the next phase of PPM
    • Ad hoc cause-and-effect analytics and reporting to investigate adverse or favorable trends and identify process improvement opportunities
    • Feature Extraction capabilities to 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 Discoverant allows the implementation of role-based Process and Product Monitoring (PPM) with automated alerts for review-by-exception to improve process performance and compliance with Continued Process Verification (CPV).

Browse By: