Release Date: August 25, 2022
The Safety 22R2.0.2 mini release introduces new enhancements. For information on what’s fixed in this release, see Fixed Issues in the Safety 22R2.0.2 Mini Release.
Localized Case Child and Grandchild Record Deletion from Case Support
Previously users were required to delete localized children manually before deleting their global versions (i.e. Local Dosage prior to removing a Dosage record). With this enhancement enabled, Localized children will be deleted when global case children are deleted.
Contact Veeva Support to enable this behaviour in your Vault. In the 22R3 release (December 2022), administrators will be able to enable this behavior through configuration.
Learn More
- Enablement: Enable Localized Record Deletion
Domestic Case Processing and Submission: Report Type-Based Localization Support
Vault Safety now supports the ability to configure localizations by Case Type. For example, this enhancement allows for the localization of Postmarket Cases for the following countries:
- Switzerland
- Czech Republic
- Spain
- Canada
Contact Veeva Support to enable this enhancement in your Vault. In the 22R3 release (December 2022), administrators will be able to enable this enhancement through configuration.
Learn More
- Enablement: Enable Domestic Case Processing for Agency Jurisdictions
- User Help:
Exclude Literature and Attachments in E2Bs by Destination Configuration
Administrators can now configure literature references and attachments to exclude them from E2B(R2) and (R3) files based on the destination of the transmission.
Learn More:
- Enablement: Enable Excluding Attachments and Literature Documents
- User Help: Generate a Regulatory Report: Exclude Attachments and Literature Documents
Distribution Reporting Obligation Evaluation for Study Cases with Non-Study Co-Suspect Products Auto-on
This release ensures the “Most Conservative Case Product and Case Assessment” reporting rules evaluation methods correctly generate Distributions for Study Cases with suspect or interacting marketed Case Products, in addition to suspect Study Product(s).
Learn More
- User Help: Configure Reporting Rules Product Selection: Most Conservative Case Product and Case Assessment
Generate Transmissions and Auto-Submit Enhancements Admin Checkbox
Administrators can now configure the system to suppress document generation for transmissions eligible for auto-submit. This resolves a possible race condition if the Evaluate Submission Obligations and Submit to Gateway actions are triggered in rapid succession.
Learn More
EDQM Dictionary Updates
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated its standard terminology for the Dose Form and Routes of Administration (RoA) data elements on E2B(R3) Submissions. As a result, Vault Safety has implemented the following changes to its standard EDQM Mappings.
New Record:
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Updated Record:
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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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