The following is a list of new features introduced in 19R3.
For each feature, the list includes information on how enablement works and which applications include the feature. You can see detailed explanations for the features below in What’s New in 19R3.
| Feature | Enablement |
|---|---|
| Case Processing | |
| Auto-Expectedness | Configuration An administrator must configure Product Datasheets to enable this feature. |
| Auto-Calculations | Auto-on |
| MedDRA Auto-Code During E2B Import | Auto-on |
| WHODrug Search Criteria Auto-Fill | Auto-on |
| WHODrug UI Enhancements | Configuration For upgraded vaults, an administrator must configure page layouts to remove the previous WHODrug field and add the new WHODrug control. |
| Case Information Ranking | Configuration For upgraded vaults, an administrator must configure page layouts on to add the Rank field. |
| Create Follow-Up Case From Potential Match | Auto-on |
| Designated Medical Events | Configuration For upgraded vaults, an administrator must configure page layouts on to add the Watchlist and DME fields. |
| Common Terminology Criteria for Adverse Events Grades | Auto-on |
| PADER Aggregate Reports | Configuration An administrator must configure the Reporting Family. |
| Device on FDA MedWatch 3500A | Configuration An administrator must configure a Device Product and, for upgraded vaults only, update product page layouts per the 19R3 data model. |
| Safety Data Exchange | |
| Configurable AS2 Gateway | Configuration Contact support to enable this feature in your vault and whitelist the corresponding partner or agency. Once enabled, an administrator must configure the AS2 Gateway. |
| EMA Gateway Submissions | Configuration An administrator must configure the EMA Gateway and, for upgraded vaults only, add reporting rules to the EMA Agency record. |
| FDA Submission Rules | Configuration For upgraded vaults, an administrator must add reporting rules to the FDA Agency record. |
| Custom Agency Submission Rules | Configuration An administrator must configure the Agency record and specify a Submission Rule. |
| Partner Distribution Rules | Configuration An administrator must configure a Partner Distribution Family or Reporting Obligation. |
| E2B Case Migration | Configuration An administrator must configure a User Action on the AER Document Lifecycle for the Migrate E2B action. |
| Receive and Acknowledge E2B Transmissions | Configuration An administrator must configure the Transmission Profile between the sender and receiving organization. |
| SafetyDocs | |
| Merge PDF Action | Configuration An administrator must configure a User Action on Document Binders for the Merge PDF action. |
| Integrations | |
| Vault Safety API | Auto-on |
Enablement Details
See the following explanations for enablement options:
| Enablement | Description | Auto-On | Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured. | Admin Checkbox | Admins must turn on the feature with an Admin checkbox. Note that some “Auto-On” features have a checkbox setting that hides the feature; these will show “Auto-On.” | Configuration | Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, an Admin must add document templates before users can create documents from templates. | Support | On/off option controlled by Support. |
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