Support for the Manufacturing Process Lifecycle

BIOVIA Discoverant supports the entire manufacturing process lifecycle from process development through scale-up and tech transfer to final production. BIOVIA Discoverant helps you with:

  • Process Design -- Understand critical process parameters to improve the design of robust GMP processes
  • Process Optimization -- Identify and reduce sources of product and process variability
  • Process Control -- Monitor variability with immediate visibility into process performance, quality and compliance risk

Understand Critical Process Parameters

  • Identify Critical Process Parameters (CPP), operating ranges and Critical Quality Attributes.
  • Scale up and transfer processes to new lines/products supporting Quality by Design.
BIOVIA Discoverant > Dassault Systemes

Supported Initiatives

BIOVIA Discoverant provides visibility throughout the product lifecycle and supply chain. It helps predict and prevent potential issues with data-driven, root-cause analysis and supports initiatives like:

  • Industry 4.0
  • Operational / Manufacturing Excellence
  • Quality by Design (QbD)
  • Tech Transfer / Outsourcing
  • Continued Process Verification (CPV)
  • Process and Product Monitoring / Visibility
  • Continuous Process Improvement (CPI)
  • Manufacturing Process Improvement (MPI)
  • Process Analytical Technology (PAT)
  • FDA Quality Metrics Program
  • Predictive Maintenance
  • Right-First-Time
  • Digital Transformation

Quality Metrics

With their "Submission of Quality Metrics Data“ guidance document, the FDA is planning to collect and analyze data from drug manufacturers on an annual basis, noting that the reports "can only be as good as the quality of available data and analytic tools." BIOVIA Discoverant provides Quality Metrics on demand in a validation-ready environment, supporting adherence to quality metrics reporting guidelines with automation. It includes Lot Acceptance Rate (LAR), Product Quality Complaint Rate (PQCR) and Invalidated Out-Of-Specification (OOS) Rate reports. A scalable infrastructure for process improvement significantly reduces overhead effort.

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