24R3 Data Model Changes: RegulatoryOne & Veeva Claims

Pre-Release Date: November 21, 2024 | Release Date: December 17, 2024

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 & Veeva Claims data model. These data model updates are automatically included in all listed application Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 24R3.

Data Model Updates - RegulatoryOne

Added components to support the RegulatoryOne & Veeva Claims Data Model Standardization feature:

• Added the following objects:
  • Local Adaptation - Substantiation (local_adaptation_substantiation__v)
  • Project Team User (project_team_user__v)
  • Regulatory Process (regulatory_process__v)
  • Regulatory Process - Requirement (regulatory_process_requirement__v)
  • Added the Competent Authority (competent_authority__v) object type to the Organization (organization__v) object.
  • Added the following object types to the Registration (registration__v) object:
    • Registration (registration__v)
    • Registration Objective (registration_objective__v)
• Added the following object types to the Registration Item (request__v) object:
  • Non-Registration Dossier (nonregistration_dossier__v)
  • Product Registration Item (product_registration_item__v)
• Added the Authority Question (authority_question__v) object type to the Regulatory Request (regulatory_request__v) object.

In support of the RegulatoryOne Standard Checkbox Defaulting feature, Vault automatically sets the following standard checkbox fields to No (false) upon record creation. This behavior only applies when the field is not configured with a default value.

• FQ Checklist (fq_checklist__sys) object: Imported (imported__v)
• Event (event__v) object: Global Operational Change (global_operational_change__v)
• Registration Item (request__v) object: Eligible for Impact Assessment (eligible_for_impact_assessment__v)
• Requirement (request_requirement__v) object:
  • Dossier Folder (dossier_folder__v)
  • Use Source (use_source__v)
• Requirement Library (requirement__v) object: EDL (edl_flag__v)

Data Model Updates - Compliance Management

Added components to support the Formulation Questionnaires: Import Attachments feature:

• Added the following objects:
  • FQ Checklist Attachment Doc (fq_checklist_attachment_doc__v)
  • FQ Question Doc Type Mapping (fq_question_doc_type_mapping__v)

Data Model Updates - Veeva Claims

Added components to support the Bulk Add Existing Claims to a Project feature:

• Added the Bulk Add to Project User Input (bulk_add_to_project_input__v) object.

Added components to support the RegulatoryOne & Veeva Claims Data Model Standardization feature:

• Added the following fields to the Claim (claim__v) object:
  • Claim Category (claim_category__v)
  • Product Name (product_name__v)
  • Re-evaluation Date (reevaluation_date__v)
  • Statement Text (statement_text__v)
• Added the Statement Text (statement_text__v) field to the Local Adaptation (local_adaptation__v) object.
• Added the Claim Category (claim_category__v) picklist.