Enable PMDA Local Case Processing Automations

Learn how to configure your Vault for Case Processing automations when reporting to the PMDA.

Last Updated Aug 25, 2023

Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

About the Feature

In the 23R2 release, Case Product Registrations and Case Assessments are now automatically populated for Domestic and Localized Cases that are reportable to Japan.

In addition, a new action enables generating Localized Assessments for Products with the same Substance as a Suspect or Interacting Case Product when reporting to the PMDA.

This feature ensures the proper selection of PMDA reportable Products and expedites the entry of associated information and J2 data elements. PMDA Local Case Processing Automations streamlines the reporting process and eliminates manual effort.

After completing the configuration steps described on this page, see the following for more information:

• Set Up the Localized Business Admin Library: Local Assessments and Expectedness
• Prepare a Localized Case: Product Registrations Section
• Prepare a Domestic Case: About PMDA Product Registration

Configure Localized Case Assessment Records

The Localized Case Assessment object must be updated with new fields and a new layout rule.

Update the Localized Case Assessment Page Layout

Complete the following steps to add the new fields to the Localized Case Assessment section of Localized Cases:

1. Go to Admin > Configuration > Objects > Localized Case Assessment > Page Layouts > Localized Case Assessment Detail Page Layout.
2. In the Details section, add the following fields:
   • Case Product
   • Case Product Registration
   • Datasheet
   • Datasheet Document
   • Override Reason
3. Select Save.

Update the Localized Case Assessment Layout Rules

While on the Localized Case Assessment Detail Page Layout page, complete the following steps to hide the Case Product Registration Assessment fields for non-Japan Localized Cases:

1. Select Layout Rules.
2. On the Layout Rules for Localized Case Assessment page, select Create.
3. On the Create Layout Rule page, complete the fields as follows:
   • Label: Enter “Hide CPR Assessment Fields”.
   • Hide the following Page Layout Items*: In the Values column, select the following fields:
     • Case Product
     • Case Product Registration
     • Datasheet
     • Datasheet Document
     • Datasheet Document (unbound)
   • IF this Layout Rule Expression is TRUE: Enter localization__vr.name__v != "Japanese (Japan)"
4. Select Save.

Configure the Localized Case Record Action

Follow the procedures below to add a user action to Localized Cases and make it available in certain lifecycle states.

Add the Localized Case Record Action

Complete the following steps to add the Retrieve Reportable Case Product Registrations action to the Localized Case object:

1. Go to Admin > Configuration > Objects > Localized Case > Actions.
2. Select Create.
3. In the Select Action field, select Retrieve Reportable Case Product Registr, and then select Continue.
4. On the Create Action page, select Save.

Update the Localized Case Lifecycle

Complete the following steps to make the Retrieve Reportable Case Product Registrations action available on Localized Cases in the following states:

• Active
• Revision

1. Go to Admin > Configuration > Object Lifecycles > Localized Case Lifecycle.
2. In the States section, select the state you want to edit.
3. In the User Actions section, select Edit.
4. Select Add Action, and then complete the following steps:
   1. Select Retrieve Reportable Case Product Registr from the picklist.
   2. In the Action Label* field, enter “Retrieve Reportable Case Product Registrations”.
5. Select Save.

Update the Localizations Page Layout

Complete the following steps to add the Assessment Generation field to Localization records:

1. Go to Admin > Configuration > Objects > Localization > Page Layouts > Localization Detail Page Layout.
2. In the Details section, add the Assessment Generation field.
3. Select Save.

Configure the Japan Localization for Assessment Generation

Complete the following steps so that Localized Cases for Japan generate Localized Case Assessments based on Case Product Registrations:

1. Go to Business Admin > Objects > Localizations > Japanese (Japan).
2. Select Edit.
3. In the Assessment Generation field, select Localized Assessments for Case Product Registrations.
4. Select Save.

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