23R3 Data Model Changes: RegulatoryOne & Veeva Claims

Pre-Release Date: November 14, 2023 | Release Date: December 12, 2023

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 23R3.

Data Model Updates - Compliance Management

Added components to support the Quantitative Assessments feature:

  • Added the following objects:
    • Formulation Concentration (formulation_concentration__v)
    • Quantitative Assessment (quantitative_assessment__v)
    • Regulatory Restriction (regulatory_restriction__v)
  • Added the following picklists:
    • Intended Use (intended_use__v)
    • Quantitative Assessment Status (quantitative_assessment_status__v)
    • Restriction Type (restriction_type__v)
  • Added the Location (location__v) field to the Regulated Category (regulated_category__v) object.

Added components to support the Automate Quantitative Assessments feature:

  • Added the Automate Quantitative Assessments Page (automate_quantitative_assessments_page__v) page.
  • Added the following notification templates:
    • Create Quant Assess Job Failure (create_quant_assess_job_failure__v)
    • Create Quant Assess Job Success (create_quant_assess_job_success__v)

Data Model Updates - Registration & Dossier Management

Added components to support the Defining Registration Item Requirement Order for Dossier Binders feature:

  • Added the Registration Item Requirement Order (registration_item_requirement_order__v) object.
  • Added the Default Order (default_order__v) field to the Requirement (requirement__v) object.

Data Model Updates - Veeva Claims

Added components to support the Simplified Substantiation Creation feature:

  • Added the following fields to the Substantiation (substantiation__v) object:
    • Related Reference (upload_related_reference_control__c)
    • Substantiation Upload (doc_upload__v)
  • Added the C1: Substantiation Document Upload Success (sub_doc_upload_success__v) notification.

Added components to support the Copied from Local Adaptation Link feature:

  • Added the following fields to the Local Adaptation (local_adaptation__v) object:
    • Source Local Adaptation (source_local_adaptation__v)
    • Source Local Adaptation Claim (source_local_adaptation_claim__v)