22R2 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 22R2.

Data Model Updates

Removed the following fields from the Quality Event object:

  • AR Contact Person (ar_contact_person__v)
  • AR Contact Person’s Details (ar_contact_details__v)
  • Authorized Representative (authorized_representative__v)
  • Importer (importer__v)
  • Importer Contact Details (importer_contact_details__v)
  • Incident - Healthcare Facility (incident_healthcare_facility__v)
  • Manufacturer (manufacturer__v)
  • Manufacturer - Contact Person (manufacturer_contact_person__v)
  • Manufacturer Contact Details (mfg_contact_details__v)
  • Manufacturing Site * Contact Info (mfg_site_contact_info__v)
  • Product Categorization (product_categorization__v)
  • Reporter’s Contact Information (reporter_contact_info__v)
  • Reporter - Occupation (reporter_occupation__v)

Added the following fields to the Training Requirement (training_requirement__v) object to support the Recurrence: Assign Training Assignment In Advance feature:

  • Assign Recurrence Before (assign_recurrence_before__v)
  • Assign Recurrence Before Unit (assign_recurrence_before_unit__v)
  • Next Training Date (Recurrence) Formula (next_training_date_recurrence_formula__v)

The following changes support the Risk Thresholds feature:

  • Added the Maximum Threshold Value (max_threshold_value__v) field to the Risk Level (risk_level__v) object.
  • Added the Risk Level Assignment (risk_level_assignment__v) field to the Risk Matrix (risk_matrix__v) object.

Made the following change for the Support 1/2/3 Dimensions for Risk Matrix feature:

  • Requiredness is now configurable for the Severity (severity__v), Occurrence (occurrence__v), and Detectability (detectability__v) fields on the Risk Matrix Setup (risk_matrix_setup__v) object.

The following change supports the Auto-Accept Document Change Requests and Periodic Review Records into a Document Change Control feature:

  • Added the Exclude from DCC Auto-Linking (exclude_from_dcc_auto_linking__v) field to the Document Change Request (document_change_request__v) object.

The following fields were added to the Quality Event object to support the External Notifications: Set Reply To Email Attributes on Complaint & Medtech Emails feature:

  • Reply To (reply_to__v)
  • From (from__v)

Made the following changes to support the External Notifications: Distribution Group Filters & Membership Automation feature:

  • Added the External Notification Membership Source (group_notification_membership_source__v) picklist.

Added the following object types on both the Record Check Result (record_check_result__v) and Record Check Match Record (record_check_match_record__v) objects to support the Extend Recurrence Check to Support Standard Object Types on Quality Event feature:

  • Change Control (change_control__v)
  • Continuous Improvement (proactive_initiative__v)
  • External Finding (external_finding__v)
  • Internal Finding (internal_finding__v)
  • Lab Investigation (lab_investigation__v)
  • Nonconformance (nonconformance__v)

The following changes were made to support the Additional Standard Fields & Objects feature:

  • Added the following fields to the Complaint Quality Event object type:
    • Amendment Date (amendment_date__v)
    • CAPA Required? (capa_required__v)
    • Cancellation Reason/Justification (cancellation_reason_justification__v)
    • Comments (comments__v)
    • Complaint Type (complaint_type__v)
    • Effectiveness Check Plan (effectiveness_check_plan__v)
    • Immediate Action Taken (immediate_action_taken__v)
    • Impact Assessment Required? (impact_assessment_required__v)
    • Initial Contact Method (initial_contact_method__v)
    • Initial Report Date (initial_report_date__v)
    • Investigation Required? (investigation_required__v)
    • Original Due Date (original_due_date__v)
    • Plan Summary (plan_summary__v)
    • Reporter Type (reporter_type__v)
    • Response Summary (response_summary__v)
    • Title (title__v)
  • Added the Category (category__v) object.
  • Added the Category Lifecycle (category_lifecycle__v) with the following states:
    • Unlocked (unlocked_state__v)
    • Inactive (inactive_state__v)
    • Locked (locked_state__v)
  • Added the Sub-Category (subcategory__v) object with the following fields:
    • Category (category__v)
  • Added the Sub-Department (subdepartment__v) object with the following fields:
    • Department (department__v)
  • Added the Quality Event-Department (quality_event_department__v) object with the following fields:
    • Department (department__v)
    • Quality Event (quality_event__v)
  • Added the Quality Event-Organization (quality_event_organization__v) object with the following fields:
    • Organization (organization__v)
    • Quality Event (quality_event__v)
  • Added the Quality Event-Document (quality_event_document__v) object with the following fields:
    • Document (document__v)
    • Document (unbound) (document_unbound__v)
    • Quality Event (quality_event__v)
  • Added the Assessment-Department (assessment_department__v) object with the following fields:
    • Department (department__v)
    • Assessment (assessment__v)
  • Added the Quality Event-Impact Assessment (quality_event_impact_assessment__v) object with the following fields:
    • Impact Assessment (impact_assessment__v)
    • Quality Event (quality_event__v)
  • Added the QE-Impact Assessment Lifecycle (qe_impact_assessment_lifecycle__v) with the following states:
    • Unlocked (unlocked_state__v)
    • Inactive (inactive_state__v)
    • Locked (locked_state__v)
  • Added the Audit-Department (audit_department__v) object with the following fields:
    • Department (department__v)
    • Audit (audit__v)
  • Added the Quality Event-Effectiveness Check (qe_effectiveness_check__v) object with the following fields:
    • Effectiveness Check (effectiveness_check__v)
    • Quality Event (quality_event__v)
  • Added the QE-Effectiveness Check Lifecycle (qe_effectiveness_check_lifecycle__v) with the following states:
    • Unlocked (unlocked_state__v)
    • Inactive (inactive_state__v)
    • Locked (locked_state__v)
  • Added the Assessment-Organization (assessment_organization__v) object with the following fields:
    • Organization (organization__v)
    • Assessment (assessment__v)
  • Added the Audit-Organization (audit_organization__v) object with the following fields:
    • Organization (organization__v)
    • Audit (audit__v)
  • Added the Audit-Organization Lifecycle (audit_organization_lifecycle__v) with the following states:
    • Unlocked (unlocked_state__v)
    • Inactive (inactive_state__v)
    • Locked (locked_state__v)
  • Added the Audit-Quality Event (audit_quality_event__v) object with the following fields:
    • Audit (audit__v)
    • Quality Event (quality_event__v)
  • Added the Audit-Quality Event Lifecycle (audit_quality_event_lifecycle__v) with the following states:
    • Unlocked (unlocked_state__v)
    • Inactive (inactive_state__v)
    • Locked (locked_state__v)
  • Added the Quality Event-Risk (quality_event_risk__v) object with the following fields:
    • Risk (risk__v)
    • Quality Event (quality_event__v)
  • Added the Quality Event-Risk Lifecycle (quality_event_risk_lifecycle__v) with the following states:
    • Unlocked (unlocked_state__v)
    • Inactive (inactive_state__v)
    • Locked (locked_state__v)
  • Added the CAPA Action-Root Cause (capa_action_root_cause__v) object with the following fields:
    • Root Cause (root_cause__v)
    • CAPA Action (capa_action__v)
  • Added the Quality Event-Change Action (quality_event_change_action__v) object with the following fields:
    • Change Action (change_action__v)
    • Quality Event (quality_event__v)
  • Added the Quality Event-Change Action Lifecycle (quality_event_change_action_lifecycle__v) with the following states:
    • Unlocked (unlocked_state__v)
    • Inactive (inactive_state__v)
    • Locked (locked_state__v)
  • Added the Impact Assessment-Product (impact_assessment_product__v) object with the following fields:
    • Product (product__v)
    • Impact Assessment (impact_assessment__v)
  • Added the Impact Assessment-Product Lifecycle (impact_assessment_product_lifecycle__v) with the following states:
    • Unlocked (unlocked_state__v)
    • Inactive (inactive_state__v)
    • Locked (locked_state__v)
  • Added the Effectiveness Check-Root Cause (effectiveness_check_root_cause__v) object with the following fields:
    • Root Cause (root_cause__v)
    • Effectiveness Check (effectiveness_check__v)
  • Added the following fields to the Root Cause object:
    • Category (_category__v_)
    • Sub-Category (_subcategory__v_)

Additionally in this release, we have introduced a new application, Study Training. This application extends Vault Training to support training on a clinical Study. Existing Training objects were updated and new objects were introduced. New objects and updates to existing objects are only used if the Study Training application is enabled.

Added the following new objects:

  • Study (study__v)
  • Study Country (study_country__v)
  • Study Site  (study_site__v)

Updated the following existing Vault Training objects:

  • Learner Role
    • New object types: Learner Role (learner_role__v) and Study Learner Role (study_learner_role__v)
    • New fields: Study Team Role (study_team_role__v)
  • LearnerRole-Person
    • Object Type enabled
    • New Object type: Study Learner Role-Persons (study_learner_role_person__v)
    • New Fields: Study (study__v), Study Country (study_country__v), Study Site (study_site__v), Matching Rule (matching_rule__v)
  • Curriculum
    • New object types: Curriculum (curriculum__v) and Study Curriculum (study_curriculum__v)
    • New Fields: Study (study__v), Study Country (study_country__v), Study Site (study_site__v), Matching Rule (matching_rule__v), Study Team Role (study_team_role__v)
  • Training Requirement and Training Assignments
    • New Fields: Study (study__v), Study Country (study_country__v), Study Site (study_site__v)

Additionally in this release, we have introduced a new application, Vault LIMS. This application adds many objects to support testing of materials for the purpose of release or use in manufacturing. These objects are only available in Vaults where LIMS has been purchased, others will see these disabled:

  • Lab Method (lims_method__v)
    • Lab Method Group (lims_method_group__v)
    • Lab Method Step (lims_lab_method_step__v)
    • Lab Result Definition (lims_material_lab_result_definition__v)
    • Lab Result Picklist (lims_lab_result_picklist__v)
    • Lab Result Picklist Option (lims_lab_result_picklist_option__v)
  • Lab Protocol (lims_protocol__v)
    • Lab Protocol Group (lims_protocol_group__v)
    • Lab Sample Definition (lims_sample_definition__v)
    • Lab Sample Definition Method (lims_sample_definition_method__v)
  • Lab Specification (lims_specification__v)
    • Lab Specification Group (lims_specification_group__v)
    • Lab Specification Criteria (lims_specification_criteria__v)
  • Material (quality_material__v)
  • Batch (quality_batch__v)
    • Lab Sample (lims_sample__v)
      • Lab Test (lims_sample_test__v)
        • Lab Test Step (lims_lab_test_step__v)
        • Lab Result (lims_result__v)
          • Lab Result Evaluation (lims_lab_result_evaluation__v)
        • Lab Test Set (material_lab_test_set__v)