19R3 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 data model. These data model updates are automatically included in all Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 19R3.

For information on Vault RIM data model changes, see 19R3 Data Model Changes: Regulatory.

Data Model Updates

Added components to support the Formula Compliance by Internal & Regulatory Agency Standards feature:

• Added the following new objects and object types to RegulatoryOne vaults: 
  • Substance Restriction (substance_restriction__v)
    • Ingredient Restriction (ingredient_restriction__v)
    • Special Ingredient Restriction (special_ingredient_restriction__v)
  • Submission Substance Restriction (submission_substance_restriction__v)
    • Submission Ingredient Restriction (submission_ingredient_restriction__v)
• Added the CAS Number (cas_number__v) field to the Active Substance (drug_substance__v) object.
• Added the Ingredient (ingredient__v) object type to the Active Substance (drug_substance_v) object.
• Added the following fields to the Submission Active Substance (submission_active_substance__rim) object:
  • Formula Ingredient (formula_ingredient__v)
  • Concentration Strength Upper Range Value (concentration_strength_upper_range_value__v)
  • Applicable Ingredient Restriction (application_ingredient_restriction__v)
  • Maximum Concentration Allowed (maximum_concentration_allowed__v)
  • Compliance Status (compliance_status__v)
  • Compliance Status Icon (compliance_status_icon__v)
  • Formula (formula__v)
  • Product (product__v)
• Added the Submission Ingredient (submission_ingredient__v) object type to the Submission Active Substance (submission_active_substance__rim) object. 
• Added the Function (function__v) field to the Product Variant Active Substance (product_detail_active_substance__rim) object.
• Added the Formula Ingredient (formula_ingredient__v) object type to the Product Variant Active Substance (product_detail_active_substance__rim) object. 
• Added the Formula Compliance Status (formula_compliance_status__v) field and Product Type (product_type__v) field to the Submission (submission__v) object.

Additional Data Model Updates

We’ve introduced Enhanced Configurability to various components in RegulatoryOne vaults:

• The Name (name__v) field for the Substance Restriction (substance_restriction__v) object.
• The following fields for the Submission Ingredient (submission_ingredient__v) object type of the Submission Active Substance (submission_active_substance__rim) object: 
  • Product (product__v)
  • Formula (formula__v)

Enhanced Configurability introduces the ability for applications to determine which field attributes in a standard object’s configuration an Admin should be able to edit. Depending on your Vault application’s data model, you may be able to edit additional settings, such as system-managed naming or if the field is required, or editing may be blocked on some of these attributes.