22R3 New Features

Learn about new features and feature enablement for the Vault Safety Suite in 22R3.

Last Updated

Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.

The following features are introduced in 22R3. For details about new features in the Vault Platform in 22R3, see the Vault Release Notes.

Safety

Vault Safety 22R3 introduces the following new features.

Intake

Features in this section are additions or improvements to case intake.

New Duplicate Search Algorithm

Support

With this release, Vault Safety offers even more search intelligence to enable surfacing similar Cases and eliminate the need for manual searching. When this feature is enabled, duplicate Cases are surfaced even when the Inbox Item includes sparse details.

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Automated Case Promotion and Bulk Manual Upload (for EMA and Other HA)

Auto-On

Vault Safety now supports automatic Inbox Item promotion for sources that rely on manually uploaded E2B files. In addition, .zip files can now be manually uploaded in bulk and processed like multi-E2B import for sources such as the EMA.

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Match Study Product / Study Product Placeholder Names

Auto-On

During E2B-import, the system can now match products and studies using the blinded product name (Study Product Placeholder) configured on Study Products in the Business Admin library.

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Create Archived Documents Directly on Batch Narrative API Import

Support

Vault Safety can now import narratives from the bulk import narrative API endpoint directly to the document archive if Document Archive is turned on in the Vault. This is to support better search performance when migrating in a large set of cases.
To use this feature, Document Archive must first be enabled by Veeva Support.

Disable Auto-Calculations on Case Promotion

Admin Checkbox

You can now bypass the calculations that occur automatically during Case promotion for Inbox Items received through AS2 gateway transmissions or Vault REST API. A new setting is introduced on the Transmission Profile, which administrators can use to control this functionality.

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Automated Case Promotion for API Transmissions

Config

With this release, support for Automated Case Promotion is extended to Safety Intake API (E2B and JSON) sources by leveraging Transmission Profiles for settings.

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Automatic Email of Case Questionnaire for Inbox Items

Config

With this release, sending a follow-up questionnaire to a primary Reporter is supported for Inbox Items. Previously, this capability was available only for AERs and Cases. In addition, Vault Safety can now email questionnaires to a non-primary Reporter, with their consent, for Cases and Inbox Items. Finally, Vault Safety can now send non-Product-specific questionnaires for Cases and Inbox Items. Previously, a Product must have been specified to send questionnaires.

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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.

IMDRF: Dictionary Maintenance, Case Processing, and Submissions

Config

Vault Safety now supports all code types for the International Medical Device Regulators Forum (IMDRF) and the management of dictionary updates. When entering a Case Product Device Problem, you can select the Device Code Type and then search for the Device Code from the IMDRF Dictionary. In addition, when generating FDA E2B(R2), FDA VAERS E2B(R3), and FDA MedWatch 3500A forms, the system can export multiple IMDRF device codes, prioritizing the lowest-level Medical Device Problem codes.

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Remedial Actions and Malfunction for Combination Products

Config

Vault Safety now supports data entry for Remedial Actions and Malfunction at the device level, as well as device codes for Cases that involve multiple Combination Products or a Combination Product that has multiple device constituents. Case Product Remedial Action and Malfunction can be exported in FDA Medwatch 3500A, FDA E2B(R2), and FDA VAERS E2B(R3) formats.

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Localized Case Child and Grandchild Record Deletion from Case

Config

Vault Safety now supports automatically deleting Localized children when global Case children are deleted. Previously, users had to delete Localized children manually before deleting the global versions. For example, Local Dosage had to be deleted prior to deleting a Dosage record.

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Domestic Case Processing and Submission: Report Type-Based Localization

Config

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
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Cosmetics, OTC Drugs, Nutritionals, and Non-Physical Devices for Case Processing

Config

With this release, to support agency-specific reporting requirements, Products can include multiple Product Registrations for different Product Types. In addition, Product Registrations can be created for the following new Product Types:

  • Cosmetics
  • OTC Drug
  • Nutritional
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Product Hierarchy Data Model

Config

This release introduces Product Family and Inactive Ingredients into the Product Data Model. Product Family can be optionally used to group related products. One or more Inactive Ingredients can be optionally added to Product Registrations when required for certain types of reporting.

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Coding

Features in this section are additions or improvements to Vault Safety medical coding capabilities.

MedDRA Synonym Field Exclusion and Candidate Auto-Creation

Config

To streamline MedDRA coding, administrators can now enable the automatic creation of synonym candidates for reported terms with no match. Synonym candidates are reviewed and approved before becoming available for coding. In addition, administrators can configure field exclusions for synonyms, which supports coding reported terms based on context.

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MedDRA Bulk Recode Cases

Config

Vault Safety now supports bulk recoding of MedDRA-coded terms on Cases. When the MedDRA Dictionary is updated to the latest version, admins can now use the Dictionary Bulk Recode feature to upload replacement terms and preview impacted terms in Cases prior to the bulk recode. Bulk recode can be applied to open and closed Cases, where changes are tracked in the audit trail.

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EDQM Dictionary Updates

Auto-On

The Vault Safety EDQM dictionary will now be automatically updated with each change to the EDQM standard terms database. Previously, EDQM updates were included with Vault Safety releases.

Reporting Rules

Features in this section are additions or improvements to the Vault Safety reporting rules engine.

Rule Set Administration Safeguards

Auto-On

This feature introduces safeguards when configuring rule parameters in custom rule sets.

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Cross Reporting Most Conservative Submission

Auto-On

With this feature, Vault Safety will support the evaluation of additional cross-reporting scenarios for situations where there are multiple cross-reporting obligations within the same jurisdiction. This feature is automatically available if cross reporting rules are enabled. Otherwise, configuration is required.

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 method correctly generates Distributions for Study Cases containing suspect or interacting marketed Case Products in addition to suspect Study Product(s).

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Submissions and Distributions

Features in this section are additions or improvements to Vault Safety Submissions and Distributions.

Translation Connections and Localized Case Auto-Translation for Submissions

Config

To facilitate the automated translation of Case text fields to local languages for submissions, Vault Safety introduces Translation Connections. This feature enables customers to use a third-party service, such as Amazon Translate, for translation. Administrators can configure Translation Connections by localization, controlling which fields are translated and setting volume limits.

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Exclude Literature and Attachment files in E2Bs by Destination

Config

Administrators 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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EMA PII Masking Exceptions

Auto-On

The enablement for EMA-compliant PII Masking, specific to when Patient Content Protection is used for an EMA Submission, will be changed to Auto-On in all Safety Vaults in 22R3. This is an enablement change from when the fix was originally patched in the 22R2.0.20 maintenance release, which required support enablement (SAF-30486).

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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.

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Aggregate Reports

Features in this section are additions or improvements to Vault Safety Aggregate Reports.

PADER Date Filtering Criteria

Support

Vault Safety will now provide a choice for the Date used to filter the reports. Aside from Transmission Date, users can choose to use Receipt Date/New Info Date instead. Contact Veeva Support to enable this behavior in your Vault. In the 23R1 release (April 2023), this behavior will be auto-on.

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Integrations

Features in this section are new integrations with Vault Safety or enhancements to existing integrations.

ClinOps-Safety Study and Study Country Vault Connection

Config

Organizations using both a Clinical Operations Vault (ClinOps) and Vault Safety can now create a Vault Connection to transfer Study and Study Registration records across Vaults. When a Study or Study Registration is created or updated in ClinOps, the data is synchronized to Vault Safety. The Safety to ClinOps connection is an important step towards ensuring compliance while reducing time and inconsistencies in managing a Study library in Vault Safety.

SafetyDocs

Vault SafetyDocs 22R3 introduces the following new features.

PSMF Automatic Logbook Generation

Config

Vault SafetyDocs can now automatically generate a PSMF logbook when merging to a PSMF PDF. Vault SafetyDocs will generate a placeholder logbook entry for each major version of a PSMF Document. This feature also includes dedicated PSMF doctypes and lifecycles that will be built upon in future releases.

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