Learn how to configure your Vault to import literature references from JAPIC and create Inbox Items and Cases from the resulting articles.

About the Feature

With this release, Vault SafetyDocs has expanded its literature management capabilities to support importing literature references from the Japan Pharmaceutical Information Center (JAPIC). This includes importing ZIP files and mapping reference information from the D-SDI.txt files within them to Literature Article records in Vault. Intake users can create Inbox Items from these records and promote them to PMDA Safety Measures or Research Report Cases.

For more information, see Import Literature References from Database Files and Create Inbox Items from Literature Articles.

Support for this feature was added in 24R2, which includes the necessary configuration by default. Vaults deployed before 24R2 must have the configuration upgrades described on this page to enable this feature.

Prerequisites

Your Vault must be licensed for both Vault Safety and Vault SafetyDocs to create Inbox Items from JAPIC articles and promote them to Cases. Contact your Veeva representative for more information.

Configure Layouts

Standard (__v) layouts were released as part of SafetyDocs Standardization 24R2. Using the table below, complete the following steps to copy the applicable standard layouts and delete custom layouts to support the JAPIC Literature Intake feature:

  1. Go to Admin > Configuration > Objects > [Object] > Layouts.
  2. Next to the standard layout, select the Actions menu and then select Save As.
  3. Review the information in the Save As dialog and select Done.
  4. Return to the [Object] > Layouts page.
  5. Next to the newly created layout, select the Actions menu and then select Set As Default.
  6. Next to the old custom layout, select the Actions menu and then select Delete > Continue.
  7. Complete these steps for all the objects in the table below:
Object Standard Layout to Copy Custom Layout to Delete
Literature Article Literature Article Detail Page Layout (literature_article_detail_layout__v) Literature Article Detail Page Layout (literature_article_detail_page_layout__c)
Literature Database Literature Database Detail Page Layout (literature_database_detail_layout__v) Literature Database Detail Page Layout (literature_database_detail_page_layout__c)
Literature Standard Search Term Literature Standard Search Term Detail Page Layout (literature_standard_search_term_layout__v) Literature Standard Search Term Detail Page Layout (literature_standard_search_term_detail_p__c)
Literature Search Term Literature Search Term Detail Page Layout (literature_search_term_detail_layout__v) Literature Search Term Detail Page Layout (literature_search_term_detail_page_layout__c)

Update Permission Set

Complete the following steps to update the Literature Actions permission set:

  1. Go to Admin > Users & Groups > Permission Sets.
  2. Select the custom Literature Actions (literature_actions__c) permission set.
  3. In the Objects tab, select Edit.
  4. Grant Read, Create, Edit, and Delete permissions on the Literature Standard Search Term object.
  5. Select Save.

Update Lifecycle Role Permissions

Complete the following steps to update role permissions on the Duplicate state of the Literature Article Lifecycle:

  1. Go to Admin > Configuration > Object Lifecycles > Literature Article Lifecycle.
  2. In the Roles section, select Edit.
  3. For each role, grant Read permissions on the Duplicate state.
  4. Select Save.