Northwest Analytics

Manufacturing intelligence for intelligent manufacturing.™

Stability Analytics

NWA Quality Analyst®

Stability studies and shelf-life prediction

NWA Stability Analytics™ delivers the statistical process control (SPC) analysis, charting, and reporting required for routine product-lot stability studies and shelf-life prediction as described in the FDA/ICH guidelines.ANCOVA based analytics to meet FDA/ICH guidelines. This SPC software module lets Life Sciences users perform routine stability analysis using NWA Quality Analyst®, the standard for manufacturing-process and laboratory-method SPC.

NWA Quality Analyst’s database connectivity and ease-of-use combine with LIMS or other shelf-life databases to create an integrated system for analyzing stability studies that performs tasks that often require multiple applications, users, and data transfers. Built-in report automation and available Web-based reporting services increase the accessibility and timeliness of information. The result is a system that is more consistent, efficient, and easier to validate and manage.

Connect directly to LIMS and study-management systems for multiple analytical views.NWA Stability Analytics Functionality

  • Meets FDA/ICH guidelines for stability analysis using ANCOVA
  • Connects directly to LIMS and other study-management systems
  • Simplifies configuration and maintenance
  • Standardizes workflow and reporting
  • Provides comprehensive stability statistics and charting
    • ANCOVA statistics
    • Tests for poolability
    • Predictions using:
      • Pooled data
      • Pooled slope
      • Worst case
    • Out-of-trend detection
    • Residuals analysis
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