Enable Safety Case Translation Agent

With the 26R3 release, Veeva Safety introduces the Translation Agent in Vaults using Vault AI for Safety. This AI tool automates verbatim translation of text fields across the intake, case processing, and reporting workflows. The Translation Agent replaces inefficient methods such as manual translation and export to external services by automatically translating free-text reported fields into your organization’s designated working language. This removes delay from getting started on Inbox Item and Case processing. In addition, designed for the translation requirements of regional authorities, such as the PMDA, the Translation Agent supports transmission compliance.

Depending on your business needs, you can configure your Vault so users can manually run the agent when translation is needed, or automatically along your workflow. The Translation Agent performs:

  • Inbound Translation: For Inbox Items and Cases, the agent translates reported text on all supported text fields from the non-working language to your configured Working Language.
  • Outbound Translation: You can configure up to 10 Localization groups and define which fields the agent translates for the related Localizations. On Localized Cases, the agent translates text into the language required by the regional health authority.

The Translation Agent translates text verbatim without enhancements or change to the clinical meaning. When text exceeds a field’s character limit, the agent makes non-substantive adjustments for small overages. Otherwise, Vault notifies users of fields that could not be translated. Global safety teams can use the agent as a tool of their quality control (QC) processes.

After you have configured this feature, see the following articles for more information:

Configure the Translation Agent

To configure the inbound and outbound settings for the Translation Agent:

  1. Navigate to Admin > Configuration, and in the Application Configurations section, select Translation Agent.
  2. On the Translation Agent page, select Edit.
  3. In the Inbound Translations: Inbox Item and Case section, select a Working Language. If you do not select a language, Vault applies English.
  4. Add up to ten Localization groups that will share the same configured fields for translation on Localized Cases:
    1. In the Outbound Translations: Localized Case section, select Add Localization.
    2. In the Add Localization dialog, select the Localizations, and then select Done.
    3. Expand the newly created Localization group, and for each listed Section, select which fields are available for translation by the agent. You can configure any standard or custom non-rich text field. Leaving a section blank results in Vault translating no fields for that section.
  5. Select Save.

For any Localizations not defined in a Localization group, Vault translates all supported fields.

Edit Localization Groups

To change the Localizations in a Localization group:

  1. On the Translation Agent page, select Edit.
  2. Select the Edit () icon for the group.
  3. Update the Localizations.
  4. Select Done.

Supported Working Languages

The Translation Agent supports the following Working Languages for translation on Inbox Items and Cases:

  • Arabic
  • Bengali
  • Chinese (Simplified)
  • English
  • French
  • German
  • Hindi
  • Indonesian
  • Italian
  • Japanese
  • Korean
  • Portuguese
  • Spanish
  • Swahili
  • Yoruba

Supported Localized Case Fields

The Translation Agent supports translating any standard or custom non-rich text field. By default, when configured, the agent translates the following object fields into the target language required for regional submission:

  • Localized Case
    • Additional Pregnancy Related Information
    • Medical History Text
    • Reporter’s Comments
    • Company Comments
    • CIOMS Remarks
    • Reporting Summary
    • Study Name
    • Study Name (Continued)
  • Localized Case Contact
    • Additional Information
  • Localized Case Product
    • Other Additional Information
    • Related Device Information
    • Product (Reported)
    • Product (Coded)
    • Registration Holder/Applicant
  • Localized Case Product Dosage
    • Dose Text
    • Parent RoA Text
    • Patient RoA Text
  • Localized Case Product Substance
    • Substance Name
  • Localized Case Product Indication
    • Name (Reported)
  • Localized Case Adverse Event
    • Event (Reported)
  • Localized Case Cause of Death
    • Cause of Death (Reported)
  • Localized Case Test Result
    • Test Name (Reported)
    • Comments
    • Result (Text)
  • Localized Case Medical History
    • Condition / Procedure (Reported)
    • Comments
  • Localized Case Drug History
    • Drug (Reported)
    • Indication (Reported)
    • Reaction (Reported)
  • Localized Case Comment
    • Comments Text
  • Localized Case Document
    • Attachment Description
    • Reference Text
  • Localized Case Assessment Result
    • Method (text)
    • Result (text)
    • Source (text)

Update Object Layouts

To display the status of translations for users, add the Translation Status field to the System section of applicable layouts for the following objects:

  • Inbox Item
  • Case (update only the layout assigned to the case__v object type)
  • Localized Case

Configure Translation Agent Actions

To support your business processes, you can configure the Translation Agent to run as a user action, an entry action, or a workflow action, as needed. Assign actions to objects as follows:

  • Translate Inbox Item to the Inbox Item object
  • Translate Case to the Case object
  • Translate Localized Case to the Localized Case object

After assigning the action, add the action to the applicable Inbox Item, Case, and Localized Case object lifecycles.

Configure Agent User with Object Permissions

You must update the Case Translation Agent User record to include a security profile and permission sets that grant the appropriate level of access to objects and fields according to your organization’s process. To complete translations, we recommend granting the Case Translation Agent User permission to Read and Edit the Inbox Item, Case, and Localized Case objects.