21R3 Data Model Changes: RegulatoryOne & Veeva Claims

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 RegulatoryOne data model. These data model updates are automatically included in all RegulatoryOne Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 21R3.

Data Model Updates - RegulatoryOne Compliance Management

Added components to support the Formulation Composition Viewer feature:

• Added the Compliance Assessment (compliance_assessment__v) object.
• Added the following picklists:
  • Compliance Assessment Status (compliance_assessment_status__v )
  • Function (function__v)
  • Regulated Category (Internal Name) (regulated_category_internal_name__v)
  • Regulated Category Type (regulated_category_type__v)
  • Unit (unit__v)
• Added the CAS Number (cas_number__v) field to the Formulation (formulation__v) object.
• Added the following fields to the Formulation Composition (formulation_composition__v) object:
  • Formulation Name (formulation_composition__v)
  • Function (function__v)
  • Target (target__v)
  • Unit (unit__v)
• Added the following fields to the Regulated Category (regulated_category__v) object:
  • Regulated Category (Internal Name) (regulated_category_viewer_label__v)
  • Regulated Category Type (regulated_category_type__v)

Data Model Updates - RegulatoryOne Registrations & Dossier Management

Added components to support the Object Field Mappings for Relational Tokens feature:

• Added the Object Mapping (object_mapping__v) tab.
• Added the following page components:
  • Object Mapping List (object_mapping_list_page__v)
  • Object Mapping Details (object_mapping_details_page__v)

Added components to support the Split Registration Items feature:

• Added the Split Rule (split_rule__v) object.
• Added the following fields to the Registration Item (request__v) object:
  • Split Rule (split_rule__v)
  • Split Source (split_source__v)
  • Split Job Status (split_requests_job_status__v)
  • Depth In Split Hierarchy (depth_in_split_hierarchy__v)

Data Model Updates - Veeva Claims

Added components to support the Selective Creation of Claims from Project feature:

• Added the following notification templates:
  • C1: Bulk Create Claims Success (bulk_create_claims_success__v)
  • C1: Bulk Create Claims Failure (bulk_create_claims_failure__v)

Added components to support the Searching Statement Text in Local Adaptations feature:

• Added the Statement (statement_ref__v) field to the Local Adaptation (local_adaptation__v) object.

Added components to support the Translator View Enhancement feature:

• Added the Local Pack Copy Element Translation Set (local_pack_copy_element_translation_set__v) object.

Additional Data Model Updates

Updated components to support Enhanced Configurability for the Formulation Object in this release:

• Added the ability to configure the attribute Values must be unique for the Formulation ID (name__v) field on the Formulation (formulation__v) object.

Updated components to support Enhanced Configurability for the Organization Object in this release:

• Added the ability to enable system-managed naming using the attribute System manages field value for the Name (name__v) field on the Organization (organization__v) object.