The Specification Dashboard uses AI to analyze Module 3 (Quality) documents and present drug substance and drug product specifications in a structured, visual format. It calculates a Health Score that summarizes the quality profile of the application.
Specification Dashboard with health score and analysis tabs
Accessing the Specification Dashboard #
- Click Reports in the sidebar.
- Click the Specification Dashboard tile.
- Select a dossier from the application selector.
Health Score #
The Health Score (0–100) summarizes the overall quality profile based on five sub-scores:
| Sub-Score | What It Measures |
|---|---|
| Specification Completeness | Are all expected specification parameters present and defined? |
| Stability Profile | Is there adequate long-term, accelerated, and stress stability data? |
| Batch Consistency | How consistent are batch results across lots? |
| Impurity Control | Are impurity levels within ICH Q3A/Q3B limits? |
| Method Validation | Are analytical methods validated to ICH Q2 standards? |
Score ranges:
| Range | Color | Meaning |
|---|---|---|
| 80–100 | Green | Strong quality profile — specifications are well-defined and data is comprehensive |
| 60–79 | Yellow | Moderate — some gaps in data or documentation that may require attention |
| 0–59 | Red | Needs attention — significant gaps in specifications or data |
Dashboard Tabs #
| Tab | What It Shows |
|---|---|
| Specification Matrix | Grid of all specification parameters with their limits, methods, and acceptance criteria |
| Stability Trending | Charts showing stability data over time (long-term, accelerated, stress) |
| Batch Performance | Batch-by-batch results compared to specification limits |
| Impurity Risk | Impurity levels mapped against ICH qualification thresholds |
| Method Readiness | Validation status of each analytical method |
Customizing Scoring #
Click Scoring Settings to adjust the weights of each sub-score. For example, if impurity control is more important for your review than method validation, you can increase its weight. Changes apply to the current session.
Exporting #
Click Export to download the full specification analysis as a spreadsheet, including all sub-scores, parameter values, and stability data.
