21R2 Data Model Changes: Regulatory

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 Regulatory data model. These data model updates are automatically included in all Regulatory Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 21R2.

The Quality to RIM Vault Connection Data Model Update adds the data model supporting the Quality to RIM Vault Connection to all RIM vaults, but the connection only works for Registrations vaults.

Added the following components to support the UDI Source Data Model Updates feature:

• Added the following object, available to all RIM vaults:
  • Clinical Study Product (clinical_study_product__v) with page layouts
  • Regulatory Text (regulatory_text__v) with object types and page layouts:
    • Device Description (device_description__v)
    • Device Indications for Use (device_indications_for_use__v)
    • Device Intended Use (device_intended_use__v)
    • Device Marketing Substatus Details (device_marketing_substatus_details__v)
    • Device Trade Name (device_trade_name__v)
  • Regulatory Text Translation (regulatory_text_translation__v) with object types and page layouts:
    • Device Description (device_description__v)
    • Device Indications for Use (device_indications_for_use__v)
    • Device Intended Use (device_intended_use__v)
    • Device Marketing Substatus Details (device_marketing_substatus_details__v)
    • Device Trade Name (device_trade_name__v)
  • Product Regulatory Text(product_regulatory_text__v) with object types and page layouts:
    • Device Indications for Use (device_indications_for_use__v)
    • Device Intended Use (device_intended_use__v)
  • Packaging Regulatory Text (packaging_regulatory_text__v) with object types and page layouts:
    • Device Description (device_description__v)
    • Device Marketing Substatus Details (device_marketing_substatus_details__v)
    • Device Trade Name (device_trade_name__v)
  • Submission Regulatory Text (submission_regulatory_text__v) with object types and page layouts:
    • Device Description (device_description__v)
    • Device Indications for Use (device_indications_for_use__v)
    • Device Intended Use (device_intended_use__v)
    • Device Marketing Substatus Details (device_marketing_substatus_details__v)
    • Device Trade Name (device_trade_name__v)
  • Regulatory Objective Regulatory Text (regulatory_objective_regulatory_text__v) with object types and page layouts:
    • Device Description (device_description__v)
    • Device Indications for Use (device_indications_for_use__v)
    • Device Intended Use (device_intended_use__v)
    • Device Marketing Substatus Details (device_marketing_substatus_details__v)
    • Device Trade Name (device_trade_name__v)
  • Shelf Life or Condition Translation (shelf_life_or_condition_translation__v) with page layouts
• Added the following objects, available to Registrations vaults:
  • Device Identifier (device_identifier__v) with object types and page layouts:
    • UDI DI (udi_di__v)
    • EUDAMED ID (eudamed_id__v)
    • Basic UDI DI (basic_udi_di__v)
    • EUDAMED DI (eudamed_di__v)
  • Registered Device Identifier (registered_device_identifier__v) with object types and page layouts:
    • UDI DI (udi_di__v)
    • EUDAMED ID (eudamed_id__v)
    • Basic UDI DI (basic_udi_di__v)
    • EUDAMED DI (eudamed_di__v)
  • UDI Submission (udi_submission__v) with object types and page layouts:
    • UDI Submission (udi_submission__v)
    • UDI Group Submission (udi_group_submission__v)
    • UDI Combined Submission (udi_combined_submission__v)
  • UDI Submission DI (udi_submission_di__v) with page layout
  • Related Registration (related_registration__v) with object types and page layouts:
    • Active Substance Registration (active_substance_registration__v)
    • Investigational Device Registration(investigational_device_registration__v)
    • Investigational Drug Registration(investigational_drug_registration__v)
    • Manufacturing Site Registration(manufacturing_site_registration__v)
    • Marketed Device Product Registration (marketed_device_product_registration__v)
    • Marketed Drug Product Registration (marketed_drug_product_registration__v)
  • Product Regulatory Authorization(product_regulatory_authorization__v) with page layout
  • Registered Authorization (registered_authorization__v) with object types and page layouts:
    • Device Certificate (device_certificate__v)
    • Device Listing (device_listing__v)
    • Device Premarket Submission (device_premarket_submission__v)
  • Regulatory Objective Authorization (regulatory_objective_authorization__v) with object types and page layouts:
    • Device Certificate (device_certificate__v)
    • Device Listing (device_listing__v)
    • Device Premarket Submission (device_premarket_submission__v)
  • Registered Regulatory Text (registered_regulatory_text__v) with object types and page layouts:
    • Device Description (device_description__v)
    • Device Indications for Use (device_indications_for_use__v)
    • Device Intended Use (device_intended_use__v)
    • Device Marketing Substatus Details (device_marketing_substatus_details__v)
    • Device Trade Name (device_trade_name__v)
  • Event Regulatory Text (event_regulatory_text__v) with object types and page layouts:
    • Device Description (device_description__v)
    • Device Indications for Use (device_indications_for_use__v)
    • Device Intended Use (device_intended_use__v)
    • Device Marketing Substatus Details (device_marketing_substatus_details__v)
    • Device Trade Name (device_trade_name__v)
• Added the Issuing Agency (issuing_agency__v) field to the Data Carrier (data_carrier__rim) object.
• Added the Health Authority Code (health_authority_code__v) field to the Risk Class (risk_class__v) object.
• Added the following fields to the Product (drug_product__v) object:
  • Active Device (active_device__v)
  • Contains Animal Tissue or Cells (contains_animal_tissue_or_cells__v)
  • Contains Human Tissue or Cells (contains_human_tissue_or_cells__v)
  • Contains Human-Derived Medicinal Product (contains_humanderived_medicinal_product__v)
  • Contains Medicinal Product Substances (contains_medicinal_product_substances__v)
  • Contains Substances of Microbial Origin (contains_substances_of_microbial_origin__v)
  • Device Model or Version (device_model_or_version__v)
  • Device Name (device_name__v)
  • Implantable Device (implantable_device__v)
  • IVD Instrument (ivd_instrument__v)
  • IVD Reagent (ivd_reagent__v)
  • Measuring Device (measuring_device__v)
• Added the following fields to the Registered Product (registered_drug_product__rim), Submission Product (submission_pharmaceutical_product__rim), and Regulatory Objective Product (regulatory_objective_drug_product__v) objects:
  • Medical Device Type (medical_device_type__v)
  • Use for UDI (use_for_udi__v)
• Added the following fields to the Clinically Relevant Size (clinically_relevant_size__v) object:
  • Maximum Value (maximum_value__v)
  • Precision (precision__v)
  • Size Description (size_description__v)
• Added the following fields to the Registered Product Characteristic (registered_product_characteristic__v), Submission Product Characteristic (submission_product_characteristic__v), Reg Objective Product Characteristic (reg_objective_product_characteristic__v) objects:
  • Administers or Removes Medicinal Product(administers_or_removes_medicinal_product__v)
  • Clinical Size (clinical_size__v)
  • Companion Diagnostic (companion_diagnostic__v)
  • Device is a Combination Product (device_is_a_combination_product__v)
  • Device is a Kit (device_is_a_kit__v)
  • Device Model or Version (device_model_or_version__v)
  • Device Name (device_name__v)
  • Exempt from Direct Marking (exempt_from_direct_marking__v)
  • Exempt from Premarket Submission (exempt_from_premarket_submission__v)
  • For Near-Patient Testing (for_nearpatient_testing__v)
  • For Patient Self-Testing (for_patient_selftesting__v)
  • For Professional Testing (for_professional_testing__v)
  • For Single-Use (for_singleuse__v)
  • Implantable IIb Exception (implantable_iib_exception__v)
  • Maximum Number of Reuses (maximum_number_of_reuses__v)
  • New Device According to EU IVDR(new_device_according_to_eu_ivdr__v)
  • Non-Medical Purpose (nonmedical_purpose__v)
  • Over the Counter (over_the_counter__v)
  • Prescription Use (prescription_use__v)
  • Product Information URL (product_information_url__v)
  • Product Identification Method (production_identification_method__v)
  • Reusable Surgical Instrument (reusable_surgical_instrument__v)
  • Special Device Type (special_device_type__v)
  • Use for UDI (use_for_udi__v)
• Added the following fields to the Packaging (packaging__rim) object:
  • Catalog or Reference Number (catalog_or_reference_number__v)
  • Contains Natural Latex or Dry Rubber (contains_natural_latex_or_dry_rubber__v)
  • Device Identifier (DI) (device_identifier__v)
  • Packaging Contained Within (packaging_contained_within__v)
  • Previous DI(previous_di__v)
  • Product (product__v)
  • Product Variant (product_variant__v)
  • Quantity (quantity__v)
  • Secondary DI(secondary_di__v)
  • Smallest Salable Unit (smallest_salable_unit__v)
• Added the following fields to the Registered Packaged Medicinal Product (registered_packaged_medicinal_product__v) object:
  • Marketing Substatus (marketing_substatus__v)
  • Marketing Substatus Scope (marketing_substatus_scope__v)
  • Marketing Substatus Start Date(marketing_substatus_start_date__v)
  • Marketing Substatus End Date(marketing_substatus_end_date__v)
  • Medical Device Type (medical_device_type__v)
  • Smallest Salable Unit (smallest_salable_unit__v)
  • Use for UDI (use_for_udi__v)
• Added the following fields to the Registered Packaging Characteristic (registered_packaging_characteristic__v), Submission Packaging Characteristic (submission_packaging_characteristic__v), and Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v) objects:
  • Labeled as Not Made With Natural Latex (labeled_as_not_made_with_natural_latex__v)
  • MRI Safety Status (mri_safety_status__v)
  • Package Type (package_type__v)
  • Packaged as Sterile (packaged_as_sterile__v)
  • Reprocessed Single-Use Device (reprocessed_singleuse_device__v)
  • Requires Sterilization Prior to Use (requires_sterilization_prior_to_use__v)
  • Smallest Salable Unit (smallest_salable_unit__v)
  • Sterilization Method (sterilization_method__v)
  • Use for UDI (use_for_udi__v)
• Added the EUDAMED CIV ID (eudamed_civ_id__v) field to the Clinical Study(clinical_study__v) object.
• Added the following field to the Registered Clinical Study (registered_clinical_study__v), Submission Clinical Study (registered_clinical_study__v), Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v), Registered Product Classification(registered_product_classification__v), Submission Product Classification(submission_product_classification__v), and Reg Objective Product Classification(reg_objective_product_classification__v) objects:
  • Use for UDI (use_for_udi__v)
• Added the following fields to the Active Substance (drug_substance__v) object:
  • EC Number (ec_number__v)
  • EUDAMED INN (eudamed_inn__v)
• Added the following fields to the Registered Active Ingredient (registered_active_ingredient__rim), Submission Active Substance (submission_active_substance__rim), and Regulatory Objective Active Substance (regulatory_objective_active_substance__v) object:
  • Substance Classification (substance_classification__v)
  • Use for UDI (use_for_udi__v)
• Added the following fields to the Organization(organization__rim) object:
  • Address Complement (address_complement__v)
  • EUDAMED Authorised Representative SRN (eudamed_authorised_representative_srn__v)
  • EUDAMED Code (eudamed_code__v)
  • EUDAMED Importer SRN (eudamed_importer_srn__v)
  • EUDAMED Manufacturer SRN (eudamed_manufacturer_srn__v)
  • EUDAMED Notified Body SRN (eudamed_notified_body_srn__v)
  • EUDAMED SPP Producer SRN (eudamed_spp_producer_srn__v)
  • GUDID Code (gudid_code__)
  • PO Box (po_box__v)
  • Street (street__v)
  • Street Number (street_number__v)
• Added the following fields to the Registered Site Organization (registered_site_organization__v), Submission Site Organization (submission_site_organization__v), and Regulatory Objective(regulatory_objective_site_organization__v) objects:
  • Make Contact Details Public (make_contact_details_public__v)
  • Product (product__v)
  • Use for UDI (use_for_udi__v)
• Added the following fields to the Regulatory Authorisation (regulatory_authorisation__v) object:
  • Authorization Number (authorization_number__v)
  • Expiry Date (expiry_date__v)
  • Certificate Type (certificate_type__v)
  • Market (market__v)
  • Notified Body (notified_body__v)
  • Revision Number (revision_number__v)
  • Supplement Number (supplement_number__v)
  • Auto-name Calculation (autoname_calculation__v)
• Added the Description (description__v) field to the Shelf Life (shelf_life__rim) object.
• Added the following object type to the Constraint (constraint__rim) object:
  • UDI Constraint (udi_constraint__v)
• Added the following object types to the Registered Product Characteristic (registered_product_characteristic__v), Submission Product Characteristic (submission_product_characteristic__v), Reg Objective Product Characteristic (reg_objective_product_characteristic__v) objects:
  • Device Product Characteristics (device_product_characteristics__v)
  • Device Product Variant Characteristics (device_product_variant_characteristic__v)
  • Device Non-Medical Purpose (nonmedical_purpose__v)
  • Device Clinical Size (device_clinical_size__v)
  • Device Production Identification Method (device_production_identification_meth__v)
• Added the following object types to the Registered Packaging Characteristic (registered_packaging_characteristic__v), Submission Packaging Characteristic (submission_packaging_characteristic__v), and Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v) objects:
  • Packaged Device Characteristics (packaged_device_characteristics__v)
  • Packaged Device Sterilization Method (packaged_device_sterilization_method__v)
• Added the following object types to the Registered Site Organization (registered_site_organization__v), Submission Site Organization (submission_site_organization__v), and Regulatory Objective (regulatory_objective_site_organization__v) objects:
  • Site Organization (site_organization__v)
  • Product Organization (product_organization__v)
• Added the following object types to the Shelf Life (shelf_life__rim), Registered Shelf Life and Storage (registered_shelf_life_and_storage__v), Submission Shelf Life Storage (submission_shelf_life_storage__v), Regulatory Objective Shelf Life Storage (regulatory_objective_shelf_life_storage__v), and Event Shelf Life and Storage (event_shelf_life_and_storage__v) objects:
  • Device Storage and Handling Condition(device_storage_and_handling_condition__v )
  • Device Critical Warning (device_critical_warning__v)
• Added the following object types to the Regulatory Authorisation (regulatory_authorisation__v) object:
  • Device Certificate (device_certificate__v)
  • Device Listing (device_listing__v)
  • Device Premarket Submission (device_premarket_submission__v)
• Added the following object types to the Packaging Shelf Life (regulatory_authorisation__v) object:
  • Packaged Device Shelf Life (packaged_device_shelf_life__v)
  • Packaged Device Storage and Handling (packaged_device_storage_and_handling__v)
  • Packaged Device Critical Warning (packaged_device_critical_warning__v)
• Enabled object types on the following objects:
  • Packaging (packaging__rim)
  • Registered Packaged Medicinal Product (registered_packaged_medicinal_product__v)
• Added the following values to the Identifier Type (identifier_type__v) picklist:
  • UDI DI (udi_di__v)
  • EUDAMED ID (eudamed_id__v)
• Added the following values to the Device Classification System (device_classification_system__v) picklist:
  • EAEU (eaeu__v)
  • EMDN (emdn__v)
  • NMPA (nmpa__v)
• Added the following value to the Organization Type (organization_type__rim) picklist:
  • Issuing Agency (issuing_agency__v)
• Added the following values to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist:
  • Medical Device Type (edical_device_type__v)
  • Non-Medical Purpose (nonmedical_purpose__v)
  • Clinical Size Precision (clinical_size_precision__v)
  • Production Identification Method (production_identification_method__v)
  • Certificate Type (certificate_type__v)
  • Special Device Type (special_device_type__v)
  • Substance Classification (substance_classification__v)
  • Marketing Substatus (marketing_substatus__v)
  • Marketing Substatus Scope (marketing_substatus_scope__v)
  • MRI Safety Status (mri_safety_status__v)
  • Sterilization Method (sterilization_method__v)
  • Critical Warning (critical_warning__v)
• Added the UDI Submission Accepted by HA (udi_submission_accepted_by_ha__v) lifecycle state type.
• Added the UDI Submission Creation Results (udi_submission_creation_results__v) notification template.
• Added the UDI (udi__v) document type and the UDI Submission (udi_submission__v) document subtype.
• Added the UDI (udi__v) document field layout.

Added the UDI Submission(udi_submission__v) document field.

Added the following components to support the Copy Into Content Plans feature:

• Added the following notification templates:
  • Copy Into Content Plan Complete (copy_into_content_plan_complete__v)
  • Copy Into Content Plan Failed (copy_into_content_plan_failed__v)

Added the following components to support the RIM Reference Model feature:

• Added the RIM Reference Model (rim_reference_model__v) high volume object.
• Added the RIM Reference Model Mapping (rim_reference_model_mapping__v) high volume object.
• Added the following picklists:
  • Version Introduced (version_introduced__v)
  • Mapping Type (mapping_type__v)
  • Mapping Location (mapping_location__v)

Added the following components to support the XEVMPD Attachment-Only Submission feature:

• Added the following shared document fields:
  • AS2 Message (as2_message_id__v)
  • Attachment Format (attachment_format__v)
  • Level 1 Acknowledgement Received (level_1_acknowledgement_received__v)
  • Level 1 Acknowledgment Result (level_1_acknowledgment_result__v)
  • Level 2 Acknowledgement Received (level_2_acknowledgement_received__v)
  • Level 2 Acknowledgment Result (level_2_acknowledgment_result__v)
  • MDN Received (mdn_received__v)
  • XEVMPD Attachment Only Submission Status (xevmpd_attachment_only_submission_status__v)
  • XEVPRM Message Integrity Check (xevprm_message_integrity_check__v)
  • XEVPRM Message Receiver (xevprm_message_receiver__v)
  • Added the Attachment Format (attachment_format__v) picklist with values.
  • Added the XEVPRM Message Receiver (xevprm_message_receiver__v) picklist with values.
  • Added the XEVMPD Submission Results (xev_submission_results__v) notification template.

Added the following components to support the Active Dossier feature:

• Added the following objects:
  • Active Dossier Template (active_dossier_template__v); Vault also includes Active Dossier Template records automatically
  • Active Dossier Structure (active_dossier_structure__v)
  • Active Dossier Item (active_dossier_item__v)
  • Active Dossier Item Detail (active_dossier_item_detail__v)
• Added the Active Dossier (active_dossier__v) tab.
• Added the Active Dossier (active_dossier__v) picklist with values.
• Added the Translation (translation__v) document relationship type.

Added the following component to support the Activity Country Dependencies feature:

• Added the following objects:
  • Activity Dependency (activity_dependency__v)*
  • Country Dependency (country_dependency__v)
• Added the following object lifecycles:
  • Country Dependency (country_dependency_lifecycle__c)_
  • Activity Dependency (activity_dependency_lifecycle__c)
• Added the following picklists with values:
  • Dependency Action (dependency_action__v)
  • Dependency Rule (dependency_rule__v)
  • Event Object Type (event_object_type__v)
• Added the Unable to create Activity Dependency (activity_dependency_result__v) notification template.

* Only available in RIM Registrations vaults.

Added the following components to support the Sequential Pagination of TOC feature:

• Added the Overall Page Number (Merge Only) (overall_page_number_merge__v) value to the Page Numbering (page_numbering__v) picklist.
• Added the Table of Contents Update Errors (subpub_toc_update_failure__v) notification template.

In addition to the changes supporting new features, we added or updated the following components:

• Added the Commitment Application (commitment_application__v) object.
• Updated the Status (status__v) field on the Dossier Details(dossier_details__v) object to be read-only.
• Updated the Dossier Details(dossier_details__v) field on the Submission (submission__v) to prevent Vault from copying the value in this field when users copy a Submission record.

In this release, we have also enabled the Required attribute on additional standard objects and fields. This allows organizations to configure these components according to their business requirements without needing to contact Veeva Support or Product Management to make these configuration changes. In order to utilize these newly-enabled attributes, Admins must perform the desired configuration to make them available for users.

Added the following components to support the PromoMats & RIM Connection feature:

• Added document type group RIM to PromoMats Connection
• Added field Related Compliance Package ID to the Submission (submission__v) object
• Added object state type Baselined