21R1 Data Model Changes: Regulatory

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Regulatory data model. These data model updates are automatically included in all Regulatory Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 21R1.

Added the following components to support the Include New IDMP Relationships in Manage Registered Details Wizard feature:

  • Added the Submission Shelf Life and Storage (submission_shelf_life_and_storage__v)* object.
  • Added the Regulatory Objective (regulatory_objective__v) field to the following objects:
    • Registered Shelf Life and Storage (registered_shelf_life_and_storage__v)
    • Registered Packaged Medicinal Product (registered_packaged_medicinal_product__v)
  • Added the following fields to Regulatory Objective Indication (regulatory_objective_indication__v) object:
    • Full Indication Text (full_indication_text__v)
    • Indication Translations (indication_translation__v)
    • Orphan Designation (orphan_designation__v)
  • Added the following values to the Impacted Record (impacted_record__v ) picklist:
    • Registered Shelf Life and Storage (registered_shelf_life_storage__v)
    • Registered Packaged Medicinal Product (registered_packaged_medicinal_product__v)

* Admins must create an object lifecycle for this object to use the feature.

Added the following components to support the XEVMPD Enhancements feature:

  • Added the XEVMPD Acknowledgement (xevmpd_acknowledgement__v) object with object types and object page layouts:
    • XEVMPD Level 1 (xevmpd_level_1__v)
    • XEVMPD Level 2 (xevmpd_level_2__v) with additional fields:
      • Attachment EV Code (attachment_ev_code__v)
      • Document EV Code (document_ev_code__v)
      • Local Number (local_number__v)
    • XEVMPD Level 3 (xevmpd_level_3__v)

Added the following components to support the QMS to Registrations Update & Resync Enhancements feature:

  • Added the following lifecycle state types to all RIM Vaults:
    • Submitted (submitted__v)
    • Implicit Approval (implicit_approval__v)

Added the following components to support the Dynamic Sorting in Submissions Archive Viewer feature:

  • Added the Ordering Date Time (ordering_date_time__v) field on Submission Metadata (submission_metadata__v) object.

Added the following components to support the Publishing Progress Indicator feature:

  • Added the Publishing Status (publishing_status__v) field, available when configuring the object page layouts on the following objects:
    • Submission (submission__v)
    • Content Plan (edl__v)
    • Content Plan Item (edl_item__v)
    • Report Level Content Plan (report_level_content_plan__v)

Added the following components to support the IDMP: Integration with RMS feature:

  • Added the following fields to the Controlled Vocabulary (controlled_vocabulary__rim) object:
    • SPOR Domain (spor_domain__v)
    • SPOR List ID (spor_list_id__v)
    • SPOR List Name (spor_list_name__v)
    • SPOR Term (spor_term__v)
    • SPOR Version (spor_version__v)
  • Added the following fields to the Language (language__rim) and Country (country__v) objects:
    • SPOR Domain (spor_domain__v)
    • SPOR List ID (spor_list_id__v)
    • SPOR List Name (spor_list_name__v)
    • SPOR Status (spor_status__v)
    • SPOR Term (spor_term__v)
    • SPOR Version (spor_version__v)
    • Valid as Of (valid_as_of__v)
  • Added additional values to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist.

Added the following components to support the Create Records in Content Plan Hierarchy Viewer feature:

  • Added the following object actions to the Content Plan (edl__v) object:
    • Create Sibling
    • Create Child
  • Added the following object actions to the Content Plan Item (edl_item__v) object:
    • Create Sibling

Added the following components to support the Continuous Non-eCTD & Publishing Elements feature:

  • Added the Publishing Element (publishing_element__v) object.
  • Added the Publishing Element (publishing_element__v) field to the following objects:
    • Content Plan Item (edl_item__v)
    • Content Plan Item Template (edl_item_template__v)
  • Added the Page Numbering (page_numbering__v) picklist.
  • Added the following components to support future functionality:
    • Added the following fields to the Medicinal Product (medicinal_product__rim) object:
    • Country (country__v)
    • Product (product__v)
    • Product Variant (product_variant__v)

Added the following components to support the Worksharing Improvements and Worksharing Improvements: Data Model Update features:

  • Added the following fields to the Regulatory Objective (regulatory_objective__rim) object:
  • Reviewing Country (reviewing_country__v)
  • Worksharing Tracking Number (worksharing_tracking_number__v)
  • Added the Worksharing (worksharing__v) object type to the Regulatory Objective (regulatory_objective__rim) object.
  • Added the Application Regulatory Objective (application_regulatory_objective__v) object.

In addition to the changes supporting new features, we added or updated the following components:

  • Added the Product Classification (product_classification__v) object.
  • Added the Applicable Product Type (applicable_product_type__v) field to the Regulatory Objective (regulatory_objective__rim) object.
  • Updated the Vault RIM UUID (vault_rim_uuid__v) field on the Country Language (country_language__v) object to require unique values.
  • Added the Published by Vault (published_by_vault__v) field to the following objects:
  • Dossier Detail (dossier_detail__v )
  • Content Plan Item (edl_item__v)
    • Removed the following lookup fields from the Content Plan Item (edl_item__v) object:
    • Report Level Plan Clinical Study (report_level_plan_clinical_study__v)
    • Report Level Plan Nonclinical Study (report_level_plan_nonclinical_study__v)
    • Report Level Plan Product Family (report_level_plan_product_family__v)
    • Submission Active Substance (submission_active_substance__rim)
    • Submission Country (submission_country__rim)
    • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
    • Submission Indication (submission_indication__rim)
    • Submission Language (submission_language__rim)
    • Submission Pharmaceutical Form (submission_pharmaceutical_form__v)
    • Submission Product (submission_pharmaceutical_product__rim)
  • Updated the cloning rules for the Risk Class (risk_class__v) and Country Language (country_language__v) objects so that cloning a sandbox Vault to a production Vault copies object records from these objects.

In this release, we have also enabled the Required attribute on additional standard objects and fields. This allows organizations to configure these components according to their business requirements without needing to contact Veeva Support or Product Management to make these configuration changes. In order to utilize these newly-enabled attributes, Admins must perform the desired configuration to make them available for users.