NWA Quality Analyst®

Stability studies and shelf-life prediction

NWA Stability Analytics™ (add-on module) 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. 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.

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