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 22R1.

Made the following changes to support the Quizzes: Question & Answer Randomization feature:

  • Added the Randomize Questions? (randomize_questions__v) field to the Section Design object.
  • Added the Randomize Answers? (randomize_answers__v) field to the Question Design object.

The following changes were made to support the Recurrence Check: Support for MedTech Complaints feature:

  • Added the Medtech Complaint (mt_complaint__v) object type to the Record Check Result and Record Check Result Match Records objects.
  • Added the Record Check Result (record_check_result__v) shared document field.

The following changes were made to support the Admin Alerts: Quiz & Recurrence feature:

  • Impact Alert: Quiz and Impact Alert: Recurrence application control fields available for the Training Requirement object page layout selections.

The following changes were made to support the Initial Training Due Date feature:

  • Added the following fields to the Training Requirement object:
    • Duration: Initial (initial_duration__v)
    • Duration Unit: Initial (initial_duration_unit__v)

The following changes were made to support the Training Jobs: New Jobs to Process Training Assignments feature:

  • Added the following fields to the Training Assignment object:
    • Training Job (training_job__v)
    • Errors Encountered? (errors_encountered__v)
    • Error Message (error_message__v)
    • Training Job ID (training_job_id__v)

The following changes were made to support the Learner Homepage: Curriculum View feature:

  • Added the Learner Homepage Card Image (learner_homepage_card_image__v) field to the Curriculum object.

The following changes were made to support the Send Email to Non-Vault Users feature:

  • Added the External Notification Recipient ([object]_external_notification_recipient__v) objects with the following fields:
    • Ext Notification Enabled Record (enr_enabled_record__v)
    • Recipient (recipient__v)
    • Distribution Group (distribution_group__v)
  • Added the Quality Event Sent Notification (quality_event_sent_notification__v) object with the following fields:
    • Bounce Reason (bounce_reason__v)
    • Distribution Group (distribution_group_recipients__v)
    • Document Package (document_package__v)
    • Email Message ID (email_message_id__v)
    • Message ID (message_id__v)
    • Message Template (message_template__v)
    • Quality Event (en_enabled_record__v)
    • Recipient (recipient__v)
    • Reply To (reply_to__v)
    • Role Recipients (role_recipients__v)
    • Sent By User (sent_by_user__v)
    • Sent Date (sent_date__v)
    • Subject (subject__v)
  • Added the Quality Event Sent Notif Lifecycle (quality_event_sent_notif_lifecycle) with the following states:
    • Delivered (delivered_state__v)
    • Email Bounced (email_bounced_state__v)
    • Inactive (inactive_state__v)
    • Opened (opened_state__v)
    • Sent (sent_state__v)
  • Added the Audit Sent Notification (audit_sent_notification__v) object with the following fields:
    • Distribution Group (distribution_group_recipients__v)
    • Document Package (document_package__v)
    • Message Template (message_template__v)
    • Audit (en_enabled_record__v)
    • Recipient (recipient__v)
    • Role Recipients (role_recipients__v)
    • Sent By User (sent_by_user__v)
    • Sent Date (sent_date__v)
  • Added the Audit Sent Notif Lifecycle (audit_sent_notif_lifecycle) with the following states:
    • Sent (sent_state__v)
  • Added the Issue Escalation Sent Notification (issue_escalation_sent_notification__v) object with the following fields:
    • Distribution Group (distribution_group_recipients__v)
    • Document Package (document_package__v)
    • Message Template (message_template__v)
    • Issue Escalation (en_enabled_record__v)
    • Recipient (recipient__v)
    • Role Recipients (role_recipients__v)
    • Sent By User (sent_by_user__v)
    • Sent Date (sent_date__v)
  • Added the Issue Escalation Sent Notif Lifecycle (issue_escalation_sent_notif_lifecycle) with the following states:
    • Sent (sent_state__v)
  • Added the Enable Reply To (enable_reply_to__v) field to the Person object.
  • Added the Reply To (reply_to__v) field to the following Quality Event object types: ComplaintMedTech Complaint.

The following changes were made to support the APQR/QMR feature:

  • Added the APQR Binder (apqr_binder__v) and Final Report (final_report__v) document types.
  • Added the following shared document fields:
    • APQR (apqr__v)
    • APQR Item (apqr_item__v)
    • QMR (qmr__v)
    • QMR Item (qmr_item__v)
  • Added the Management Review Template (content_template__v) object with the following fields:
    • Country (country__v)
    • Owning Facility (owning_facility__v)
    • Product (product__v)
    • QMR Scope (qmr_scope__v)
  • Added the Management Review Template Lifecycle with the following states:
    • Initiated (initiated__v)
    • In Approval (in_approval__v)
    • Approved (approved__v)
    • Retired (retired__v)
  • Added the Management Review Template Item (content_template_item__v) object with the following fields:
    • Management Review Template (content_template__v)
    • Document (document__v)
    • Display Order (display_order__v)
  • Added the APQR (apqr__v) object with the following fields:
    • Country (country__v)
    • Owning Facility (owning_facility__v)
    • Product (product__v)
    • Management Review Template (content_template__v)
    • Data Start Date (data_start_date__v)
    • Data End Date (data_end_date__v)
    • APQR Due Date (apqr_due_date__v)
    • APQR Binder (apqr_binder__v)
  • Added the APQR Lifecycle with the following states:
    • Approved (approved__v)
    • Completed (completed__v)
    • Data Preparation Completed (data_preparation_completed__v)
    • In Approval (in_approval__v)
    • In Data Preparation (in_data_preparation__v)
    • Initiated (initiated__v)
  • Added the APQR Items (apqr_item__v) object with the following fields:
    • APQR (apqr__v)
    • Document (document__v)
    • Display Order (display_order__v)
  • Added the APQR Item Lifecycle with the following states:
    • Created (created__v)
    • Initiated (created__v)
    • In Progress (in_progress__v)
    • Complete (complete__v
  • Added the QMR Scope (qmr_scope__v) picklist.
  • Added the QMR (qmr__v) object with the following fields:
    • QMR Scope (qmr_scope__v)
    • Owning Facility (owning_facility__v)
    • Data Start Date (data_start_date__v)
    • Data End Date (data_end_date__v)
    • QMR Due Date (qmr_due_date__v)
    • Meeting Minutes (meeting_minutes__v)
    • Meeting Agenda (meeting_agenda__v)
    • QMR Presentation (qmr_presentation__v)
    • Management Review Template (content_template__v)
  • Added the QMR Lifecycle (qmr_lifecycle__v) with the following states:
    • Initiated (initiated__v)
    • In Data Preparation (in_data_preparation__v)
    • Data Preparation Completed (data_preparation_completed)
    • In Approval (in_approval__v)
    • Approved (approved__v)
    • Meeting in Progress (meeting_in_progress__v)
    • Completed (completed__v)
  • Added the QMR User Task (qmr_task__v) object with the following fields:
    • QMR (qmr__v)
  • Added the QMR Item (qmr_item__v) object with the following fields:
    • QMR (qmr__v)
    • Document (document__v)
  • Added the QMR Item Lifecycle (qmr_item_lifecycle__v) with the following states:
    • Created (created__v)
    • Initiated (created__v)
    • In Progress (in_progress__v)
    • Complete (complete__v)
  • Added the Related QMR (related_qmr__v) field to the Quality Event object.

The following changes were made to support the High Volume Object Preparation: Field Configuration Limitations feature:

  • The following field configuration limitations now apply to Training Assignment and Assignment Details objects:
    • Field types that support field-level encryption
    • More than two (2) multi-value picklist fields

The following changes were made to support the Standard Cycle Time Metrics: Audit Object & Quality Event Custom Object Type Support feature:

  • Added the Audit Cycle Time Metric (audit_cycle_time_metric__v) object with the following fields:
    • Audit (audit__v)
    • Cycle Time Start Date (cycle_time_start_date__v)
    • Scheduled Start Date (scheduled_start_date__v)
    • Scheduled End Date (scheduled_end_date__v)
    • Actual Start Date (actual_start_date__v)
    • Actual End Date (actual_end_date__v)
    • Cycle Time Stop Date (cycle_time_stop_date__v)
    • Cycle Time (cycle_time__v)
    • Audit Preparation Cycle Time (audit_preparation_cycle_time__v)
    • Audit Reporting/Response Cycle Time (audit_reporting_response_cycle_time__v)
    • Planned vs. Actual Audit Start Delta (planned_actual_audit_start_delta__v)
    • Planned vs. Actual Audit Duration Delta (planned_actual_audit_duration_delta__v)
  • Added the Custom (custom__v) object type to the Quality Event Cycle Time Metric object.