22R1 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 22R1.

Data Model Updates - RegulatoryOne Compliance Management

Added components to support the Formulation Questionnaires feature:

• Added the following objects:
  • Application Managed User (app_managed_user__v)
  • Industry (industry__v)
  • Formulation Questionnaire (formulation_questionnaire__v)
  • ​FQ Available Answer (fq_available_answer__sys)
  • FQ Checklist (fq_checklist__sys)
  • FQ Dependency (fq_dependency__sys)
  • FQ PAL Context (fq_pal_context__v)
  • FQ Response (fq_response__sys)
  • FQ Response-Doc (fq_response_doc__sys)
  • FQ Response-Ref-Doc (fq_response_ref_doc__sys)
  • FQ Section (fq_section__sys)
  • FQ Sub-checklist (fq_subchecklist__sys)
• Added the Supplier (supplier__v) field to the Formulation (formulation__v) object.
• Added the Checklist Respondent Type (checklist_respondent_type__v) field to the Organization Person (organization_person__v) object.
• Added the FQ Checklist Type (fq_checklist_type__v) object type to the Checklist Design (checklist_design__sys) object.
• Added the Formulation Questionnaire Invitation (fq_invitation__v) object message.
• Added the following picklists:
  • Application User Management Type (app_user_management_type__v)
  • Checklist Respondent Type (checklist_respondent_type__v)
• Added the following workflows:
  • FQ Accepted (fq_accepted_wf__sys)
  • FQ Pending Acceptance (fq_pending_accept_wf__sys)
• Added the following object lifecycles:
  • FQ Checklist Lifecycle (fq_checklist_lc__sys)
  • FQ PAL Checklist (fq_response_lc__sys)
  • FQ Response Lifecycle (fq_response_lc__sys)
• Added the PAL FQ Checklist Respondent (pal_fq_checklist_respondent__v) security profile.
• Added the PAL FQ Checklist Respondent (pal_fq_checklist_respondent__v) permission set.
• Added the Checklist Respondent (checklist_respondent__sys) application role.

Added components to support the Formulation Composition Viewer Enhancements feature:

• Added the Assessment Status Color (assessment_status_color__v) field to the Compliance Assessment (compliance_assessment__v) object.

Data Model Updates - RegulatoryOne Registration & Dossier Management

Added components to support the Local Impact Assessment feature:

• Added the following objects:
  • Regulated Category Attribute Impact (regulated_category_attribute_impact__v)
  • Registration Request (registration_request__v)
• Added the following fields to the Registration Item (request__v) object:
  • Eligible for Impact Assessment (eligible_for_impact_assessment)
  • Generate Registration and Obj Job Status (generate_registration_objective_job_status__v)
  • Generate Registration Data Job Status (generate_registration_data_job_status__v)
  • Local Impact Assessment Job Status (local_impact_assessment_job_status__v)
  • Matching Registration (matching_registraton_field__v)
  • Matching Registration Objective (matching_registraton_objective_field__v)
  • Registration (parent_registration__v)
  • Regulated Category (regulated_category__v)
  • Regulatory Process Type (regulatory_process_type__v)
• Added the following picklists:
  • Regulated Category Attribute Impact Type (category_attribute_impact_type__v)
  • Regulatory Process Type (regulatory_process_type__v)

Added components to support the Create Dossier Binder feature:

• Added the following fields to the Registration Item Requirement (request_requirement__v) object:
  • Binder (binder__v)
  • Dossier Folder (dossier_folder__v)

Added components to support the Generate Requirements from Registration Objective feature:

• Added the following fields to the Registration (registration__v) object:
  • Generate Requirements Job Status (generate_requirements_job_status__v)
  • Select Root Requirement (select_root_requirement__v)
• Added the following fields to the Registration Item Requirement (request_requirement__v) object:
  • Registration (registration__v)
  • Registration Objective (registration_objective__v)

Added components to support the Split Registration Items Enhancement: Recursion feature:

• Added the Output Structure (output_structure__v) field to the Split Rule (split_rule__v) object.
• Added the following fields to the Registration Item (request__v) object:
  • Split Parent (split_parent__v)
  • Depth in Split Parent Hierarchy (depth_in_split_parent_ hierarchy__v)
• Added Split Rules Output Structure (split_rule_output_structure__v) picklist.

Added components to support the Track Authority Questions feature:

• Added the Regulatory Request (regulatory_request__v) object.

Data Model Updates - Veeva Claims

Added components to support the Dynamic Deep Copy Project feature:

• Added the following notification templates:
  • C1: Project Deep Copy Success (project_deep_copy_success__v)
  • C1: Project Deep Copy Failure (project_deep_copy_failure__v)
• Added the Clone Project (clone_project_page__v) page component.

Added components to support the Copied from Project Link feature:

• Added the Copied from Project (copied_from_project__v) field to the Project (project__v) object.

Added components to support the Auto-Populate Statement Translations for Local Adaptations feature:

• Added the following notification templates:
  • C1: Populate Statement Translations Success (la_statement_translation_success__v)
  • C1: Populate Statement Translations Failure (la_statement_translation_failure__v)

Additional Data Model Updates

Added components to support the Enable Checklists in RegulatoryOne feature:

• Added the following objects:
  • Answer Library Design (answer_library_design__sys)
  • Available Answer (available_answer__sys)
  • Available Answer Design (available_answer_design__sys)
  • Checklist (checklist__sys)
  • Checklist Design (checklist_design__sys)
  • Checklist Design Master (checklist_design_master__sys)
  • Dependency (dependency__sys)
  • Dependency Design (dependency_design__sys)
  • Library Question (library_question__sys)
  • Library Question Reference Document (library_question_reference_document__sys)
  • Question Design (question_design__sys)
  • Question Design Reference Document (question_design_reference_document__sys)
  • Response (response__sys)
  • Section (section__sys)
  • Section Design (section_design__sys)
  • Sub-checklist Design (subchecklist_design__sys)
• Added the following object lifecycles:
  • Available Answer Design Lifecycle (available_answer_design_lifecycle__sys)
  • Checklist Design Lifecycle (checklist_design_lifecycle__sys)
  • Checklist Lifecycle (checklist_lifecycle__sys)
  • Question Design Lifecycle (question_design_lifecycle__sys)
  • Question Design Reference Doc Lifecycle (question_design_reference_doc_lifecycle__sys)
  • Response Lifecycle (response_lifecycle__sys)
  • Section Design Lifecycle (section_design_lifecycle__sys)
  • Sub-Checklist Design Lifecycle (subchecklist_design_lifecycle__sys)
• Added the following workflows:
  • Accepted Workflow (accepted_workflow__sys)
  • Pending Acceptance Workflow (pending_acceptance_workflow__sys)

Added components to support the Product Hierarchy Data Model Extension for Packaging feature:

• Added the following objects:
  • Packaging (packaging__v)
  • Packaging Composition (packaging_composition__v)
  • Product-Packaging (product_packaging__v)

Unlocked the following objects in all RegulatoryOne Vaults:

• Organization (organization__v)
• Organization Person (organization_person__v)