NWA Stability Analytics
Overview of NWA Stability Analytics
NWA Stability Analytics delivers the statistical analysis, charting, and reporting required for routine product-lot stability studies and shelf-life prediction as described in the FDA/ICH guidelines. This new module lets Life Sciences users perform routine stability analysis using NWA Quality Analyst®, the standard for manufacturing-process and laboratory-method SPC.
Straightforward data structure simplifies database queries and workflow. Simple forms let you select analysis type, studies to analyse, and statistical parameters.
Graphical output includes the analysis of Pooled Data, Pooled Slope, and Worst Case results showing the data points, regression lines, confidence intervals, and the specification intercept.
Quality Analyst’s database connectivity and ease-of-use combine with LIMS or other shelf-life databases to create an integrated system for analysing 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.
- Provides Comprehensive Stability Statistics and Charting
- Complies with FDA/ICH Guidelines
- Connects Directly to LIMS and other systems
- Simplifies Configuration and Management
- Standardises Workflow and Reporting
The NWA Quality Analyst Stability Analytics module:
- Meets FDA/ICH guidelines for stability analysis using ANCOVA
- Connects directly to LIMS and other study-management systems
- Simplifies configuration and maintenance
- Standardises 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
The detailed ANCOVA report includes comprehensive statistical results, significance tests for pooling slopes and comparing intercepts, and shelf-life estimates.
Additional charts and reports let you detect out-of-trend results and analyse residuals.
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