23R3 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 23R3.

23R2.2

The following changes were made to support the Quality Incidents Data Model & Lifecycle feature:

  • Added the Quality Incident (quality_incident__v) object and Quality Incident Lifecycle (quality_incident_lifecycle__v)
  • Added the Related Quality Incident (related_quality_incident__v) field to the following objects
    • Quality Event (quality_event__qdm)
    • Change Control (change_control__v)
    • Complaint (complaint__v)
    • Continuous Improvement (continuous_improvement__v)
    • Deviation (deviation__v)
    • Lab Investigation (lab_investigation__v)
    • MedTech CAPA (medtech_capa__v)
    • Nonconformance (nonconformance__v)

Added the following components to support the QRM: Additional Risk Assessment Methodologies feature:

  • Added the following object types to the Assessment (fmea_risk_assessment__v) and Assessment Risk (fmea_risk_event__v) objects:
    • dFMEA (d_fmea__v)
    • uFMEA (u_fmea__v)
    • Generic (generic__v)
    • What - If (what_if__v)
    • HAZOP (hazop__v)
    • HACCP (haccp__v)
    • Hazard - Harm (hazard_harm__v)
  • Added the Hazard Library (hazard_library__v) object.
  • Added the Assessment - Hazard (assessment_hazard__v) object.
  • Added the HAZOP Node (hazop_node__v) object.
  • Added the Harm (harm__v) object.

Added the following components to the support the Standard Data Model for Legacy Archive Data feature:

  • Added the following objects:
    • Legacy System (legacy_system__v)
    • Legacy Process Record (legacy_process_record__v)
    • Legacy Process Record Artifact (legacy_process_record_artifact__v)
    • Related Legacy Process Record (related_legacy_process_record__v)
  • Added the Legacy System Lifecycle (legacy_system_lifecycle__v)

23R2.3

The following fields were modified to allow administrators the ability to modify the required attribute:

  • Change made to fields on the SCN Impact Assessment (scn_impacted_assessment__v) object
    • Description (description__v)
    • Assessment Summary (assessment_summary__v)
    • Impacted Site (impacted_site__v)
  • Changes made to fields on the Issue Escalation (issue_escalation__v) object
    • Date of Occurrence (occurrence_date__v)

To support the Create Person Automatically feature, added the following object lifecycle state types to the Person object lifecycle (person_lifecycle__v):

  • Eligible (eligible_state_type__v)
  • Ineligible (ineligible_state_type__v)

To support the Create User Automatically feature, added or updated the following components:

  • Added the Managed by Training (managed_by_training__v) picklist
  • Added the Managed by Training (managed_by_training__v) picklist field to the User (user__v) and User Role (user_role__v) objects.

The following changes were made to to support the Standard Data Model for Legacy Archive Data feature, released with 23R2.2:

  • The Values must be unique attribute has been enabled for the external_id__v field in the following objects: Legacy Process Record and Legacy Process Record Artifact.  After the attribute is enabled, an email will be sent to Vault Owners when the uniqueness job is completed.

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

  • Added the following fields to the Visual Hierarchy object:
    • Visual Hierarchy Image 1 (visual_hierarchy_image1__v)
    • Visual Hierarchy Image 2 (visual_hierarchy_image2__v)
    • Visual Hierarchy Image 3 (visual_hierarchy_image3__v)

The following changes were made to support the Complaint Automated Email Ingestion feature:

  • Added the Complaint Email (complaint_email__v) and Quality Event Email (quality_event_email__v) objects.
  • Added several system-controlled fields to the Quality Event and Complaint objects. These fields are only intended to be populated by the email processor and should not be used for other purposes.
  • Added the Complaint Email object type to the Quality Event and Complaint objects.

The following changes were made to support the Quality/ClinOps: Issue Management Connector feature:

  • Added the object type GCP Deviation to the Quality Event (quality_event__qdm) object
  • Added the Clinical Issue Link (clinical_issue_link__v) field to the Quality Event and Deviation objects

The following changes were made to support the Additional Prompts for Test Steps feature:

  • Added the following fields to the Test Step (test_step_svo__v) object:
    • Procedure Setting (procedure_setting__v)
    • Expected Results Setting (expected_result_setting__v)
    • Verdict Setting (verdict_setting__v)
    • Procedure Fit to Width? (procedure_fit_to_width__v)
    • Actual Results Fit to Width? (actual_results_fit_to_width__v)
    • Expected Results Fit to Width? (expected_result_fit_to_width__v)
  • Added the Test Step Additional Prompt (val_test_step_additional_prompt__v) object

The following changes were made to support the Auditor Profiles & Qualifications feature:

  • Added the following objects:
    • Auditor Profile (auditor_profile__v)
    • Auditor Role (auditor_role__v)
    • Role Qualification Criteria (role_qualification_criteria__v)
    • Required Qualification Criteria (required_qualification_criteria__v)
    • Qualifications to Complete (qualification_to_complete__v)
    • Role Qualification Status (role_qualification_status__v)
    • Auditor History (auditor_history__v)

The following changes were made to support the VPS: Reportability Assessment Enhancements feature:

  • Added the AER Validation Lifecycle (aer_validation_lifecycle__v) standard object lifecycle

The following changes were made to support the QMS Feature Parity for MedTech Objects feature:

  • Added the following fields to the Related Event (related_event__v) object:
    • Source Nonconformance (source_nonconformance__v)
    • Related Nonconformance (related_nonconformance__v)
    • Source MedTech CAPA (source_medtech_capa__v)
    • Related MedTech CAPA (related_medtech_capa__v)
  • Added the following fields to the Effectiveness Check (effectiveness_check__qdm) object:
    • Nonconformance (nonconformance__v)
  • Added the following fields to the Root Cause Analysis (root_cause_analysis__v) object:
    • Nonconformance (nonconformance__v)
    • MedTech CAPA (medtech_capa__v)
  • Added the following fields to the Root Cause (root_cause__qdm) object:
    • Nonconformance (nonconformance__v)
    • MedTech CAPA (medtech_capa__v)
  • Added the following fields and field changes to the Quality Event Cycle Time Metric (quality_event_cycle_time_metric__v) object:
    • Nonconformance (nonconformance__v)
    • MedTech CAPA (medtech_capa__v)
    • Set requiredness on existing Quality Event field (quality_event__v) to No and not editable
  • Added the following fields to the External Collaborator Assignment (external_collaborator_assignment__v) object:
    • Nonconformance (nonconformance__v)
  • Added the following fields to the Record Check Result (record_check_result__v) object:
    • Nonconformance (nonconformance__v)
    • MedTech CAPA (medtech_capa__v)
  • Added the following fields to the Record Check Match Record (record_check_match_record__v) object:
    • Related Nonconformance (related_nonconformance__v)
    • Related MedTech CAPA (related_medtech_capa__v)
  • Made the following field attribute changes to the Record Check Result (record_check_result__v) field on the Nonconformance (nonconformance__v) and MedTech CAPA (medtech_capa__v) objects:
    • Do not copy this field in Copy Record set to Yes and this attribute is no longer editable
    • Allow create new reference record set to No and this attribute is no longer editable
  • Added the following objects:
    • Nonconformance - Effectiveness Check (nonconformance_effectiveness_check__v)
    • MedTech CAPA - Effectiveness Check (medtech_capa_effectiveness_check__v)

The following changes were made to support the QRM: Risk Visualization Heatmap feature:

  • Added the Criticality Level (criticality_level__v) object.
  • Added the following fields to the Risk Matrix Setup (risk_matrix_setup__v) object to store the Criticality Level and Criticality Score (Severity x Occurrence):
    • Criticality Level (criticality_level__v)
    • Criticality Score (criticality_score__v)
  • Added the following fields to the Assessment Risks (fmea_risk_event__v) object to store the initial and residual Criticality Level and Criticality Score (Severity x Occurrence):
    • Initial Criticality Level (initial_criticality_level__v)
    • Initial Criticality Score (initial_criticality_score__v)
    • Residual Criticality Level (residual_criticality_level__v)
    • Residual Criticality Score (residual_criticality_score__v)
  • Added the following fields to the Risks (risk_event__v) object to store the initial and residual Criticality Level and Criticality Score (Severity x Occurrence):
    • Initial Criticality Level (initial_criticality_level__v)
    • Initial Criticality Score (initial_criticality_score__v)
    • Residual Criticality Level (residual_criticality_level__v)
    • Residual Criticality Score (residual_criticality_score__v)

23R2.4

To support the Invite Sites to Register for VeevaID feature, added the Uses VeevaID (uses_veevaid__v) field to the Training Role (learner_role__v) object and its object type, Study Team Role (study_learner_role_v).

The following changes were made to support the QMS Feature Parity for QMS<>RIM feature:

  • Added the Change Control (change_control__v) field to the Impact Assessment (change_control_impact_assessment__v) object
  • Added the Change Control (change_control_sa__v) field to the QMS/RIM Transaction (qms_rim_transaction__v) object