21R1 Data Model Changes: Quality

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 Quality data model. These data model updates are automatically included in all Quality Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 21R1.

The following changes were made to support the Station Manager: Record Based Categorization feature:

• Added the Station Manager Category (station_manager_category__v) object with the following fields:
  • Category Label (name__v)
• Added the Station Document Categorization (station_document_categorization__v) object with the following fields:
  • Station Document (station_document__v)
  • Station Manager Category (station_manager_category__v)
• Added the Station Manager Category Lifecycle (station_manager_category_lifecycle__v) object lifecycle with the following states:
  • Approved (approved__v)
  • Inactive (inactive__v)
• Added the Station Document Categorization LC (station_document_categorization_lc__v) object lifecycle with the following states:
  • Approved (approved__v)
  • Inactive (inactive__v)

The following changes were made to support the Updates to Cloning Rules for Vault Training Objects feature:

The following objects are no longer cloned:

• Learner Role (learner_role__v)
• Curriculum (curriculum__v)
• Training Requirement (training_requirement__v)
• Curriculum-Learner Role (curriculum_learner_role__v)
• Training Requirement-Curriculum (training_requirement_curriculum__v)

The following changes were made to support the Maximum Attempts for Quizzes feature:

• Added the Unlock Quiz User Input (unlock_quiz_user_input__v) object with the following fields:
  • Name (name__v)
  • Quiz Unlock User Input Type (object_type__v)
  • Additional Attempts (additional_attempts__v)
  • New Due Date (new_due_date__v)
• Added the following fields to the Checklist Design (checklist_design__sys) object and enabled on Quiz Checklist Design (vdta_checklist_design__sys) object type:
  • Max Attempts Required? (max_attempts_required__v)
  • Max Attempts (max_attempts__v)
  • Auto Unlock? (auto_unlock__v)
  • Lockout Period (Days) (lockout_period_days__v)
  • Auto Update Due Date? (auto_update_due_date__v)
  • Extended Due Date Duration (extended_due_date_duration__v)
• Added the following fields to the Training Assignment (training_assignment__v) object and enabled on Vault Document Training Assignment (vault_document_training_assignment__v) and External Training Assignment (external_training_assignment__v) object type:
  • Max Attempts Required? (max_attempts_required__v)
  • Max Attempts (max_attempts__v)
  • Attempts Remaining (attempts_remaining__v)
  • Total Attempts (total_attempts__v)
  • Auto Unlock? (auto_unlock__v)
  • Lockout Period (Days) (lockout_period_days__v)
  • Quiz Locked On (quiz_locked_on__v)
  • Quiz Unlock Date/Time (quiz_unlock_datetime__v)
  • Auto Update Due Date? (auto_update_due_date__v)
  • Extended Due Date Duration (extended_due_date_duration__v)
  • Quiz Locked (quiz_locked__v)
• Added the following field to the TA Checklist (ta_checklist__sys) object:
  • Last Attempt? (last_attempt__v)

The following changes were made to support the Vault Product Surveillance application:

• Added a new lifecycle: Reportable Event Lifecycle (reportable_event_lifecycle__v)

The following changes were made for the EU MIR: Data Model Changes feature, to support future functionality:

• Added Health Authority (health_authority__v) object type to Organization (qms_organization__qdm)
• Added the following fields to the Organization (qms_organization_qdm) object:
  • NCA EUDAMED # (nca_eudamed_no__v)
  • Notified Body Id # (notified_body_id__v)
  • Health Authority Type (health_authority_type__v)
• Added the following object type to the Person (person_sys) object:
  • Contact (contact__v)
• Inactivated the following objects:
  • Reporter (reporter__v)
  • Contacts (contact__v)
• Added following object type to Reportable Event (reportablre_event__v) object with new data fields:
  • EU MIR (eu_mir__v)
• Added following new objects with associated data fields:
  • Single Registration Number (single_registration_number__v)
    • Organization (organization__v)
    • Organization Capacity (org_capacity__v)
    • Single Registration Number (srn__v)
    • Country (country__v)
  • Person – Organization (person_organization__v)
    • Organization (organization__v)
    • Person (person__v)
  • Contact Information (contact_information__v)
    • Organization (organization__v
    • Person (person__v)
    • Contact Type (contact_type__v)
    • Unit (unit__v)
    • Street Name (street_name__v)
    • Street Number (street_number__v)
    • Address Details (address_details__v)
    • Additional Address Info (additional_address_info__v)
    • City (city__v)
    • Postal Code (postal_code__v)
    • Zip Code (zip_code__v)
    • Zip Extension (zip_extension__v)
    • PO Box (po_box__v)
    • State (state_address__v)
    • Country (country__v)
    • Primary Email (primary_email__v)
    • Email 2 (email_2__v)
    • Email 3 (email_3__v)
    • Primary Phone (primary_phone__v)
    • Phone 2 (phone_2__v)
    • Phone 3 (phone_3__v)
    • Primary Fax (primary_fax__v)
    • Fax 2 (fax_2__v)
    • Fax 3 (fax_3__v)
    • Website (website__v)
  • Notified Body Product (notified_body_product__v)
    • Notified Body Name (notified_body_name__v)
    • Notified Body (NB) Certificate Number (nb_cert_num__v)
    • Product (product__v)
  • Multi Device Reportable Event (multi_device_reportable_event__v)
    • Reportable Event (reportable_event__v)
    • Multi Device -NCA Reference # (nca_ref_multi_dev__v)
    • Multi Device -EUDAMED Reference # (eudamed_ref_multi_dev__v)
    • Multi Device -Manufacturer Reference # (mfr_ref_multi_dev__v)
  • FSCA Reportable Event (fsca_reportable_event__v)
    • Reportable Event (reportable_event__v)
    • FSCA NCA Reference # (nca_ref_fsca__v)
    • FSCA EUDAMED Reference # (eudamed_ref_fsca__v)
    • FSCA Manufacturer Reference # (mfr_ref_fsca__v)
  • PSR (psr__v)
    • Reportable Event (reportable_event__v)
    • PSR ID (psr_id__v)
  • PMCF/PMPF (pmcf_pmpf__v)
    • Reportable Event (reportable_event__v)
    • PMCF/PMPF EUDAMED Id (pmcf_pmpf_eudamed_id__v)
  • Similar Incidents (similar_incidents__v)
    • Reportable Event (reportable_event__v)
    • Region (region__v)
    • Period (period__v)
    • Start Date (start_date__v)
    • End Date (end_date__v)
    • Similar Incidents (similar_incidents__v)
    • No. of Devices (no_of_devices__v)

The following changes were made for the QMS: Product & Supplier Data Model to support expanded usage of Supplier Quality Management:

• Added the following object types to Organization (qms_organization__qdm)
  • Supplier Site (supplier_site__v)
  • Internal Organization (internal_organization__v)
  • Internal Site (internal_site__v)
• Added the following field to the Organization (qms_organization__qdm) object:
  • Parent Organization (parent_organization__v)
• Added the SCAR (scar__v) object with the following additional fields:
  • Supplier (supplier__v)
  • Quality Event (quality_event__v)
  • Description (description__v)
  • Title (title__v)
  • Due Date (due_date__v)
• Added the Qualification (qms_org_qualification__v) object with the following additional fields:
  • Material (material__v)
  • Product (product__v)
  • Part / Component (part__v)
  • Supplier (supplier__v)
  • Qualification Date (qualification_date__v)
  • Expiration Date (expiration_date__v)

The following changes were made to support expanded usage of a Product hierarchy:

• Added the Product Family (product_family__v) object with the following additional fields:
  • Therapeutic Area (therapeutic_area__v)
  • Generic Name (generic_name__v)
  • Abbreviation (abbreviation__v)
• Added the Product Form (product_form__v) object with the following additional fields:
  • Product Family (product_family__v)
• Added the following field to the Product (product__v) object:
  • Product Family (product_family__v)
  • Product Form (product_form__v)

The following changes were made to support the Process Navigator feature:

• Added the Visual Hierarchy (visual_hierarchy__v) object with the following additional fields:
  • Icon (icon__v)
  • Parent (parent__v)
  • Position within Parent (position_within_parent__v)
• Added the Hierarchy Document (hierarchy_document__v) object with the following additional fields:
  • Hierarchy Record (hierarchy_record__v)
  • Document (document__v)

The following changes were made to support the Prerequisite Training feature:

• Added the following object types to Training Rule Set (training_rule_set__v)
  • Prerequisite Training Rule Set (prerequisite_training_rule_set__v)
• Added the following fields to Training Rule Set (training_rule_set__v)
  • Training Rule Set Expression (TR ID) (training_rule_set_expression_tr_ids__v)
  • Training Rule Set Expression (Ext ID) (training_rule_set_expression_ext_ids__v)
  • Training Rule Set Expression (Display) (training_rule_set_expression_display__v)
  • Training Requirement Curriculum (training_requirement_curriculum__v)
  • External ID (external_id__v)
• Added the following object types to Training Rule (training_rule__v)
  • Prerequisite Training Rule (prerequisite_training_rule__v)
• Added the following fields to Training Rule (training_rule__v)
  • Training Requirement Curriculum (training_requirement_curriculum__v)
  • External ID (external_id__v)
• Added the following fields to Training Assignment (training_assignment__v)
  • Prerequisite Status (prerequisite_status__v)
  • Training Rule Set Expression (TR IDs) (training_rule_set_expression_tr_ids__v)
  • Training Rule Set Expression (Display) (training_rule_set_expression_display__v)
• Added the following fields to Related Training Assignment (related_training_assignment__v)
  • Relationship Type (relationship_type__v)
  • Training Assignment Fulfillment Status (training_assignment_fulfillment_status__v)
  • Learner (learner__v)

The following changes were made to support the Learner Homepage: Resources Section feature:

• Added the following Layouts to the Vault Training Learner Homepage: My Learning Page (training_my_learning_page__v)
• My Learning Page Layout (training_my_learning_page_layout__v)

The following changes were made to support the Use Document Date Field as Due Date feature:

• Added the following fields to Training Requirement (training_requirement__v) object:
  • Document Revision Training Due Date (document_revision_training_due_date__v)
• Added the following fields to Training Requirement Impact Assessment (training_requirement_impact_assessment__v) object:
  • Document Revision Training Due Date (document_revision_training_due_date__v)

The following changes were made for the US FDA eMDR Enhancements feature, to support future functionality:

• Added a new document classification: Attachment (classification_attachment__v)
  • VPS Reportable Event Document > eMDR > Attachment

The following changes were made to support the Self-Registration for Classroom Training feature:

• Added a standard picklist Allow Self-Registration? (allow_self_registration__v) with the following standard values:
  • Learners can self-register (learners_can_self_register__v)
  • Learners cannot self-register (learners_cannot_self_register__v)
• Added a standard picklist Self-Registration Status (self_registration_status__v) with the following standard values:
  • Pending, Training Requirement allows self-registration (pending_tr_allows_self_registration__v)
  • Pending, Training Requirement does not allow self-registration (pending_tr_disallows_self_registration__v)
  • Open for self-registration (open_for_self_registration__v)
  • Closed for self-registration (closed_for_self_registration__v)
• Added the following field to the Training Requirement (training_requirement__v) object:
  • Allow Self-Registration? (allow_self_registration__v)
• Added the following field to the Training Assignment (training_requirement__v) object:
  • Allow Self-Registration? (allow_self_registration__v)
• Added the following fields to the Class Schedule (class_schedule__v) object:
  • Self-Registration Status (self_registration_status__v)
  • Maximum Attendees (maximum_attendees__v)
  • Minimum Attendees (minimum_attendees__v)

The following changes were made for the US FDA eMDR Enhancements feature, to support future functionality:

• Added a new document classification: Attachment (classification_attachment__v)
  • VPS Reportable Event Document > eMDR > Attachment

The following changes were made for the EU MIR: Data Model Changes feature, to support future functionality:

• Added Health Authority (health_authority__v) object type to Organization (qms_organization__qdm)
• Added the following fields to the Organization (qms_organization_qdm) object:
  • NCA EUDAMED # (nca_eudamed_no__v)
  • Notified Body Id # (notified_body_id__v)
  • Health Authority Type (health_authority_type__v)
• Added the following object type to the Person (person_sys) object:
  • Contact (contact__v)
• Inactivated the following objects:
  • Reporter (reporter__v)
  • Contacts (contact__v)
• Added following object type to Reportable Event (reportable_event__v) object with new data fields:
  • EU MIR (eu_mir__v)
• Added following new objects with associated data fields:
  • Single Registration Number (single_registration_number__v)
  • Organization (organization__v)
  • Organization Capacity (org_capacity__v)
  • Single Registration Number (srn__v)
  • Country (country__v)
  • Person – Organization (person_organization__v)
    • Organization (organization__v)
    • Person (person__v)
  • Contact Information (contact_information__v)
    • Organization (organization__v
    • Person (person__v)
    • Contact Type (contact_type__v)
    • Unit (unit__v)
    • Street Name (street_name__v)
    • Street Number (street_number__v)
    • Address Details (address_details__v)
    • Additional Address Info (additional_address_info__v)
    • City (city__v)
    • Postal Code (postal_code__v)
    • Zip Code (zip_code__v)
    • Zip Extension (zip_extension__v)
    • PO Box (po_box__v)
    • State (state_address__v)
    • Country (country__v)
    • Primary Email (primary_email__v)
    • Email 2 (email_2__v)
    • Email 3 (email_3__v)
    • Primary Phone (primary_phone__v)
    • Phone 2 (phone_2__v)
    • Phone 3 (phone_3__v)
    • Primary Fax (primary_fax__v)
    • Fax 2 (fax_2__v)
    • Fax 3 (fax_3__v)
    • Website (website__v)
  • Notified Body Product (notified_body_product__v)
    • Notified Body Name (notified_body_name__v)
    • Notified Body (NB) Certificate Number (nb_cert_num__v)
    • Product (product__v)
  • Multi Device Reportable Event (multi_device_reportable_event__v)
    • Reportable Event (reportable_event__v)
    • Multi Device -NCA Reference # (nca_ref_multi_dev__v)
    • Multi Device -EUDAMED Reference # (eudamed_ref_multi_dev__v)
    • Multi Device -Manufacturer Reference # (mfr_ref_multi_dev__v)
  • FSCA Reportable Event (fsca_reportable_event__v)
    • Reportable Event (reportable_event__v)
    • FSCA NCA Reference # (nca_ref_fsca__v)
    • FSCA EUDAMED Reference # (eudamed_ref_fsca__v)
    • FSCA Manufacturer Reference # (mfr_ref_fsca__v)
  • PSR (psr__v)
    • Reportable Event (reportable_event__v)
    • PSR ID (psr_id__v)
  • PMCF/PMPF (pmcf_pmpf__v)
    • Reportable Event (reportable_event__v)
    • PMCF/PMPF EUDAMED Id (pmcf_pmpf_eudamed_id__v)
  • Similar Incidents (similar_incidents__v)
    • Reportable Event (reportable_event__v)
    • Region (region__v)
    • Period (period__v)
    • Start Date (start_date__v)
    • End Date (end_date__v)
    • Similar Incidents (similar_incidents__v)
    • No. of Devices (no_of_devices__v)