Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
The Vault Safety 22R2.0.2 mini release introduces new enhancements. For information on what’s being fixed in this release, see the 22R2.0.2 Fixed Issues.
Case Processing
Features in this section are additions or improvements to case processing, including data entry, triage, medical review, auto-calculations, and general case management.
Localized Case Child and Grandchild Record Deletion from Case
SupportPreviously 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
SupportVault 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
Submissions and Distributions
Features in this section are additions or improvements to Vault Safety Submissions and Distributions.
Exclude Literature and Attachments in E2Bs by Destination
ConfigAdministrators can now configure literature references and attachments to exclude them from E2B(R2) and (R3) files based on the destination of the transmission.
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Distribution Reporting Obligation Evaluation for Study Cases with Non-Study Co-Suspect Products
Auto-OnThis 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).
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Generate Transmissions and Auto-Submit Enhancements
Admin CheckboxAdministrators 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.
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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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