Process Production Operations

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

Quality Metrics

Support Quality Data Submission for the FDA's Quality Metrics Program

The purpose of the FDA's draft guidance for industry for the "Submission of Quality Metrics Data" is to drive improvements in manufacturing technology, product quality, and potentially even help companies mitigate drug shortages. The agency 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".

The current version of the draft guidance includes the following metrics:

  • Lot acceptance rate (LAR)
  • Product quality complaint rate (PQCR)
  • Invalidated out-of-specification (OOS) rate

Based on these metrics submitted to the FDA the agency is planning for risk-based drug inspection scheduling.

BIOVIA Discoverant is an industry solution that supports the aggregation, analysis and sharing of Quality Metrics in single point-and-click GMP compliant environment. BIOVIA Discoverant allows to:

  • Automatically aggregate and organize raw data from multiple systems (e.g., complaints, QMS, process) including paper data and Excel uploads for CMOs
  • Standardize calculations from raw data
  • Automate dashboarding for holistic visibility
  • Easily validate the system and ensure data integrity

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BIOVIA Discoverant provides Quality Metrics on demand in a validation-ready environment allowing organizations for:

  • Full adherence to quality metric reporting guidelines
  • Automation for significantly reduced overhead effort
  • Scalable infrastructure for process improvement efforts

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