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.
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
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| Straightforward data structure simplifies database queries and workflow. Simple forms let you select analysis type, studies to analyse, and statistical parameters. |
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| 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. |
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| The detailed ANCOVA report includes comprehensive statistical results, significance tests for pooling slopes and comparing intercepts, and shelf-life estimates. |
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| Additional charts and reports let you detect out-of-trend results and analyse residuals. |
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