24R3 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 24R3.

In support of the Study Training & Vault Training Standard Checkbox Defaulting feature, Vault will automatically set the below standard checkbox fields to No (false) upon record creation. This behavior only applies when the field is not configured with a default value.

• Person object (person__sys): Person is not a Vault user (person_is_not_a_vault_user__v)
• Study object (study__v): Errors Encountered during Publish? (publish_encountered_errors__v)
• Training Assignment object (training_assignment__v): Person is not a Vault user (person_is_not_a_vault_user__v)
• Training Requirement object (training_requirement__v): Non-Study Specific Training? (non_study_specific_training__v)

Study Training customers can also reference 24R3 Data Model Changes: Clinical Operations.

The following updates are in support of the Instructor-Led Training: Maximum Attendees & Waitlisting feature:

• Added the Manually Manage Waitlist? field (manually_manage_waitlist__v) to the Class Schedule object (class_schedule__v).
• Added the Classroom Waitlist object (classroom_waitlist__v)
• Added the following picklists:
• Waitlist Source (waitlist_source__v)
• Waitlist Status (waitlist_status__v)
• Waitlist Removal Reason (waitlist_removal_reason__v)

The following updates are in support of the Complaints Email Processor Update: Support for Complaint Intake feature:

• Added the following fields to the Complaint Intake standard object type on the Complaint Intake (complaint_intake__v) standard object:
  • Sender Email Address (sender_email_address__v)
  • Email Body (email_body__v)
  • Email Text (email_text__v)
  • Vault Email Inbox Address (vault_email_inbox_ address__v)
  • Message ID (message_id__v)
  • Root Message ID (root_message_id__v)
  • Type of Complaint (type_of_complaint__v)
  • Promote to Complaint Required? (promote_to_complaint_required__v)
  • Triage Assessment (triage_assessment__v)
• Added the following standard picklist values to the Type of Complaint (type_of_complaint__v) standard picklist:
  • Pharma Complaint (pharma_complaint__v)
  • MedTech Complaint (medtech_complaint__v)
• Added the Complaint Intake Emails (complaint_intake_email__v) standard object to join the Email (email__sys) and Complaint Intake (complaint_intake__v) standard objects with the following fields:
  • Complaint Intake (complaint_intake__v)
  • Email (email__v)

The following updates are in support of the Action Paths: Support Change Action Templates feature:

• Added the following fields to the Change Action Template (change_action_template__v) standard object:
  • Action Path ID (action_path_id__v)
  • Action Step ID (action_step_id__v)

The following are in support of the 24R3 Standard App Enhancements for Vault Validation Management feature:

• DAC has been locked and can no longer be modified by admins for the below objects. It is critical that DAC is disabled (unchecked) by admins for all of these objects prior to 24R3 if they were enabled at some point prior to 24R3:
  • val_team_assignment__v
  • val_team_role__v
  • val_role_dependency__v
  • val_inventory_item__v
  • val_entity__v
  • val_entity_family__v
  • val_requirement_svo__v
  • val_related_requirement_svo__v
  • val_requirement_entity_version_svo__v
  • val_activity__v
  • val_deliverable_svo__v
  • val_deliverable_entity_version__v
  • val_test_protocol_svo__v
  • val_test_script_svo__v
  • val_test_script_execution_change__v
  • val_test_step_svo__v
  • val_test_step_change_svo__v
  • val_test_step_additional_prompt__v
  • val_discrepancy__v
  • val_related_discrepancy_svo__v
  • val_rtm_svo__v
  • val_template_requirement__v
  • val_template_requirement_set__v
  • val_template_req_template_req_set__v
  • val_test_co_author__v
  • val_requirement_suffix__v
• Added standard lifecycle states to the Validation Entity Lifecycle (val_inventory_lifecycle__v):
  • Obsolete (obsolete_state__v)
  • In Entity Family Review (in_entity_family_review_state__v)
• Custom fields can no longer be added by admins on the following simple join objects. If a custom field exists, please remove the custom field prior to the 24R3 release:
  • Validation Requirement Entity Version (val_requirement_entity_version_svo__v)
  • Validation Deliverable Entity Version (val_deliverable_entity_version__v)
  • Related Discrepancy (val_related_discrepancy_svo__v)
  • Template Req - Template Req Set (val_template_req_template_req_set__v)
  • Test Co-Author (val_test_co_author__v)
• Modified the Test Structure (val_deliverable_test_structure__v) picklist so that the standard picklist status values can be modified from Active to Inactive and from Inactive to Active by an admin from the Vault UI.
• Added new fields on the Validation Entity Version (val_entity__v) object:
  • Asset (asset__v)
  • Cancellation Date (cancellation_date__v)
  • Cancellation Justification (cancellation_justification__v)
• Added new fields on the Validation Activity (val_activity__v) object:
  • External Change Control ID (external_chnage_control_id__v)
  • Activity Due Date (activity_due_date__v)
  • Amendment Date (amendment_date__v)
  • Cancellation Date (cancellation_date__v)
  • Cancellation Justification (cancellation_justification__v)
• Added the following standard picklist values on the Activity Type (val_activity_type__v) picklist and made those values inactive by default:
  • Commissioning (commissioning__v)
  • Initial Qualification (initial_qualification__v)
  • Monitoring (monitoring__v)
  • Requalification (requalification__v)
• Added the following fields on the Validation Deliverable (val_deliverable_svo__v) object:
  • Cancellation Date (cancellation_date__v)
  • Cancellation Justification (cancellation_justification__v)
  • Completion Status (completion_status__v)
• Added the following fields on the Validation Deliverable (val_deliverable_svo__v) object:
  • Cancellation Date (cancellation_date__v)
  • Cancellation Justification (cancellation_justification__v)
  • Completion Status (completion_status__v)
• Added the following fields on the Validation Test Script (val_test_script_svo__v) object:
  • Date Authoring Started (date_authoring_started__v)
  • Date Execution Started (date_execution_started__v)
  • Date Post-Approved (date_postapproved__v)
  • Date Pre-Approved (date_preapproved__v)
  • Cancellation Date (cancellation_date__v)
  • Cancellation Justification (cancellation_justification__v)
• Added the following standard picklist values on the Test Type (val_test_type__v) picklist and made those values inactive by default:
  • DQ (dq__v)
  • PPQ (ppq__v)
• Added the following fields on the Validation Test Protocol (val_test_protocol_svo__v) object:
  • Date Authoring Started (date_authoring_started__v)
  • Date Execution Started (date_execution_started__v)
  • Date Post-Approved (date_postapproved__v)
  • Date Pre-Approved (date_preapproved__v)
  • Cancellation Date (cancellation_date__v)
  • Cancellation Justification (cancellation_justification__v)
  • Test Type (test_type__v)
• Added the following fields on the Validation Requirement (val_requirement_svo__v) object:
  • Cancellation Date (cancellation_date__v)
  • Cancellation Justification (cancellation_justification__v)
  • Workflow Status (workflow_status__v)
  • Backlog (backlog__v)
• Added a new object type Configuration Specification (configuration_specification__v) with a status of inactive on the Validation Requirement (val_requirement_svo__v) object.
• Added the External Trace (external_trace__v) field on the Traceability Matrix (val_rtm_svo__v) object.

The following updates are in support of the External Collaboration: Supplier Questionnaires feature:

• Added the new Audit Collaborator Assignment (audit_collaborator_assignment__v) object type to the External Assignment Collaborator (external_collaborator_assignment__v) raw object. This object type contains only the Audit (audit__v) field.
• Added the new External Collaborator (external_collaborator__v) field to the Audit (audit__v) object.
• Added the following new notification templates:
  • Welcome: qms_extcollab_welcome_audit__v
  • Goodbye: qms_extcollab_goodbye_audit__v
  • Welcome back: qms_extcollab_welcomeback_audit__v

The attached document contains the data model updates in support of the 24R3 QMS Standard Layout & Data Model Updates feature.

The following updates are in support of the Material/Product Data Model feature:

• Added the following standard object to Quality Vaults:
  • Material - Product (material_product__v) - This object is used to map materials to the Product hierarchy objects.
• Added the following fields on the Related Material (quality_related_material__v) existing object:
  • Create Reciprocal Link Error Reason (recip_auto_error__v)
  • Reciprocal Link ID (reciprocal_link_id__v)

The following updates are in support of the Recurrence Check Data Model Changes feature for Vault QMS:

• Added the following fields on the Record Check Results (record_check_result__v) object
  • Applied Filters (applied_filters__v)
  • Default Filters (default_filters__v)

The following updates are in support of the Audit Room feature for Vault QMS:

• Added the following standard Objects to Quality Vaults
  • Inspection Request (inspection_request__v) - This object stores Inspection Requests associated to an Inspection/Audit and their associated attributes
    • Lifecycle: Inspection Request Lifecycle
  • Inspection - Inspector (inspection_inspector__v) - this object joins Inspectors to the various Inspections/Audits they participate in
    • Lifecycle: Inspection Inspector Lifecycle
  • Inspection Request - Document (inspection_request_document__v) - This object relates Inspection Requests with vault documents that fulfill them
• Added the following standard object types and fields to existing objects in Quality Vaults
  • Audit (audit__v)
    • Object Type: Inspection (inspection__v)
    • Fields:
      • Inspection organization (inspection_organization__v) - a reference to the Organization object representing the inspecting entity
      • Scribe Notes (scribe_notes__v) - a reference to the Vault Document which, via Collaborative Authoring, supports collaboration in Audit Rooms
  • Person (person__v)
    • Object Type: Inspector (inspector__v)

• Added the following standard components to Quality Vaults

  • Picklists - 
    • Request Category (request_category__v) - defines different types of categorization for Inspection Requests
    • Request Priority (request_priority__v) - defines different values of urgency for prioritizing Inspection Requests
    • Inspector Status (inspector_status__v) - definitions of the status of Inspection Requests for presentation to Inspectors.
  • Tab Collection - QMS (qms__v)
  • Application Roles
    • Inspection Inspector (inspection_inspector__v)
    • Front Office (front_office__v)
    • Fulfiller (fulfiller__v)
  • Security Profile - Inspector User (inspector_user__v)
  • Permission Set - Inspector (inspector_permissions__v)

The following updates are in support of the Field Corrective Actions (Recall Management) Data Model and related Automations features for Vault QMS:

• Added the following standard objects to Quality Vaults. Objects are standard data store objects unless otherwise indicated.
  • Field Corrective Action (field_corrective_action__v) - stores primary information associated with a given field corrective action
    • Lifecycle: Field Corrective Action Lifecycle (field_corrective_action_lifecycle__v)
  • FCA - Lot (fca_lot__v) - Raw Object - joins field corrective actions to lots of product product lot
    • Lifecycle: FCA Lot Lifecycle (fca_lot_lifecycle__v)
  • FCA - Organization (fca_organization__v) - associates organizations to their field corrective actions
    • Lifecycle: FCA Organization Lifecycle (fca_organization_lifecycle__v)
  • FCA - Product Variant (fca_product_variant__v) - associates product variants to all applicable field corrective actions.
    • Lifecycle: FCA Product Variant Lifecycle (fca_product_variant_lifecycle__v)
  • FCA - HHE (fca_hhe__v) - associates field corrective actions to applicable health hazard evaluations 
    • Lifecycle: FCA HHE Lifecycle (fca_hhe_lifecycle__v)
  • Health Hazard Evaluation (health_hazard_evaluation__v) - defines Health Hazard Evaluations within the system
    • Lifecycle: Health Hazard Evaluation Lifecycle (health_hazard_evaluation_lifecycle__v)
  • HHE - Lot (hhe_lot__v) - Raw Object - joins Health Hazard Evaluations to lots of product product lots
  • Implementation Action (implementation_action__v) - defines the various actions taken as a part of an FCA.
    • Lifecycle: Implementation Lifecycle (implementation_lifecycle__v)
  • Product / Material Tracking (product_material_tracking__v) - stores information regarding the tracking of activities regarding amounts return/servicing of products and materials and their disposition involved in FCAs
    • Lifecycle: Product Material Tracking Lifecycle (product_material_tracking_lifecycle__v)
  • Product / Material Tracking Outreach (product_material_tracking_outreach__v) - Raw Object - stores information specific to individual outreach actions associated with a given consignee FCA’s product/material tracking actions
    • Lifecycle: Product Material Tracking Outreach Lifecycle (product_mat_tracking_outreach_lc__v)
  • Lot - Consignee (lot_consignee__v) - Raw Object - joins Person to Lot to store consignee information for a given Lot
• Added the following standard object types and fields to existing objects in Quality Vaults
  • Fields added to Containment (containment__v)
    • Date Closed (date_closed__v) - date to be used for closure of the containment activity
    • Planned Completion Date (plannned_completion_date__v) - anticipated resolution date for the containment activity
    • Planned Containment? (planned_containment__v) - whether or not a containment was planned
    • Owner (owner__v) - owner for this containment activity
    • Field Corrective Action (field_corrective_action__v) - the Field Corrective Action that this containment activity is a part of
    • Contact Person (contact_person__v) - the primary contact person for this containment activity
  • Fields added to Product Return (product_return__v)
    • Date Closed (date_closed__v) - date to be used for closure of the product return activity
    • Owner (owner__v) - owner for this product return activity
  • Fields added to Correction (correction__v)
    • Date Closed (date_closed__v) - date to be used for closure of the product return activity
    • Owner (owner__v) - owner for this product return activity
    • MedTech CAPA (medtech_capa__v) - links this Correction to a specific CAPA
    • Product Impact (product_impact__v) - details whether or not there is a material impact on the product due to this correction
  • Fields added to Product Variant (product_variant__v)
    • Device Type (device_type__v) - details the type of device that categorizes a given product variant.

• Added the following standard components to Quality Vaults

  • Picklists: 
    • Field Actions (field_actions__v) - The type of action to be taken as part of a Field Corrective Action
    • HHE: Hazards (hhe_hazards__v) - defines the various types of hazards recognized by your organization for use in health Hazard Evaluations
    • Implementation Action Type (implementation_action_type) - defines the categorizations or types of implementation actions that may be a part of Field Corrective Action resolution 
    • Attempt Method (attempt_method__v) - standard values have been added for email, fax, mail, and phone. Defines the methods of communication that can be attempted when performing Product / Material Outreach actions associated with FCAs
    • Person Type (person_type__v) - The type (with this release - internal or external) of the person who is involved in a given FCA
    • Device Type (device_type__v) - the types of device that can categorize a Product Variant within your organization.

The following updates are in support of the Dry Run for Test Scripts feature in Vault Validation Management:

• Added the Validation Test Script Comment (val_test_script_comment__v) object

• Added the following fields on the Test Script (val_test_script_svo__v) object
  • Dry Run Required? (dry_run_required__v)
  • Test Script Dry Run? (test_script_dry_run__v)
  • Source Test Script for Dry Run (source_test_script_dry_run__v)
• Added the following fields and made available to all object types for the Test Step (val_test_step_svo__v) object
  • Source Test Script for Dry Run Steps (source_test_script_step_dry_run__v)
  • Source Test Step for Dry Run (source_test_step_dry_run__v)
• Added the following fields and made available to all object types for the Test Step Additional Prompt (val_test_step_additional_prompt__v) object
  • Source Prompt for Dry Run (source_prompt_dry_run__v)

The following updates are in support of the Reason for Change feature:

• Added the Reason for Change (reason_for_change__v) object

The following updates are in support of the Mark Training Complete in Bulk feature:

• Facilitated Training Request object (facilitated_training_request__v): Enabled the following object configuration options:
  • Allow attachments
  • Enable Signatures
• Facilitated Training Request object (facilitated_training_request__v): Added new object types and fields:
  • Multi-Object Facilitated Request (multi_object_facilitated_request__v) object type
  • Fields (Active on the new object type):
    • Completion Method (completion_method__v)
    • Completion Date (completion_date__v). Note: This is an existing field made Active on all object types.
    • Notes (notes__v)
• Added the Completion Method picklist (completion_method__v)
• Added the VT: Facilitated TR: E-Signature workflow (facilitated_training_request_esig__v)
• Added the Bulk Training Completions job (bulk_training_completions_job__v)
• For the Direct Assignment Request object (direct_assignment_request__v): Updated the Due Date field (due_date__v) to be optional (via the User must always enter a value (required) option).

The following updates are in support of the E-Learning: Support Reporting on Locked Quizzes feature:

• Added the E-Learning Quiz Status picklist (e_learning_quiz_status__v)
• Added the E-Learning Quiz Status field (e_learning_quiz_status__v) and Number of Quiz Attempts field (number_of_quiz_attempts__v) to the following objects and object types:
  • E-Learning Status Detail object (e_learning_status_detail__v) and its SCORM 1.2 Status Detail object type (scorm_12__v)
  • Training Content Status object (training_content_status__v) and its E-Learning Content Status object type (e_learning__v)

To support a future Study Training feature (VeevaID Single Sign-On Support for Study Training), added the Federated ID field (federated_id__v) to the Person object (person__sys) as inactive. We also added an inactive rule for this field to the Study Training ClinOps: Person integration rule (st_co_person_ir__v). As these elements will not be usable until the feature is released, Admins should not activate them.

The following updates are in support of the Require Re-Training User Action feature:

• Added the following raw objects:
  • Retraining Request (retraining_request__v)
  • Retraining Request User Input (retraining_request_user_input__v)

• Added the Retraining Request (retraining_request__v) field to the Training Assignment object (training_assignment__v) and all of its object types.

• Added the following picklists:
  • Retraining Reason (retraining_reason__v)
  • Training Request Fulfillment Status (training_request_fulfillment_status__v)
• Added the Retraining value (retraining__v) to the Creation Reason (creation_reason__v) picklist.

The following updates are in support of the Learner Exemption Requests feature:

• Added the Learner Request object (learner_request__v) with the Exemption (exemption__v) object type.
• Added the Learner Request Lifecycle (learner_request_lifecycle__v)

• Added the Allow Learner Exemption field (allow_learner_exemption__v) to the Training Requirement object (training_requirement__v) and all its object types.

• Added the following fields to the Training Assignment object (training_assignment__v) and all its object types:
  • Allow Learner Exemption (allow_learner_exemption__v)
  • Evidence Completion Date (evidence_completion_date__v)
• Added the following picklists:
  • Request Source (request_source__v)
  • Request Status (request_status__v)
  • Recurrence Based On (recurrence_based_on__v)

The following updates are in support of the Check Object Class Conversion feature for the Batch Release application:

• Added the Batch Disposition Check Task (batch_disposition_check_task__v) object
• Deprecated the Batch Disposition Check (batch_disposition_check__v) object