21R1 Data Model Changes: RegulatoryOne

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 21R1.

Removed components to support the Obsolete RegulatoryOne Data Model feature. Note that the data model changes for this feature apply to customers who adopted RegulatoryOne up to, and including, 20R3:

  • Removed the following objects:
    • Substance Restriction (substance_restriction__v) object with object types:
      • Ingredient Restriction (ingredient_restriction__v)
      • Special Ingredient Restriction (special_ingredient_restriction__v)
    • Submission Substance Restriction (submission_substance_restriction__v) object with object type:
      • Submission Ingredient Restriction (submission_ingredient_restriction__v)
    • Ingredient List (ingredient_list__v)
    • Ingredient List Product Variant (ingredient_list_product_variant__v)
    • Ingredient List Active Substance (ingredient_list_active_substance__v)
    • Submission Ingredient List (submission_ingredient_list__v)
    • Raw Material (raw_material__v)
    • Raw Material Variant (raw_material_variant__v)
    • Product Variant Raw Material (product_variant_raw_material__v)
    • Raw Material Variant Active Substance (raw_material_variant_active_substance__v)
    • Submission Raw Material (submission_raw_material__v)
    • Formula Ingredient Function (formula_ingredient_function__v)

Added components to support the Product Hierarchy Data Model feature. Note that the data model changes for this feature apply to customers who adopt RegulatoryOne for 21R1.

  • Added the following objects:
    • Product (product__v)
    • Product Composition (product_composition__v)
    • Formulation (formulation__v)
    • Formulation Composition (formulation_composition__v)

Added components to support the Registration & Dossier Management Data Model feature. Note that the data model changes for this feature apply to customers who adopt RegulatoryOne for 21R1:

  • Added the following objects:
    • Event (event__v)
    • Request (request__v)
    • Registration (registration__v)
    • Requirement (requirement__v)
    • Request Requirement (request_requirement__v)
    • Distribution Channel (distribution_channel__v)