21R2 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 21R2.

The following changes were made to support the On the Job Training Type feature:

Added the following fields to the Training Requirement (training_requirement__v) object:

  • Object Type (evaluation_training_requirement__v)
  • Evaluation Design(evaluation_design__v)
  • Learning Objectives (learning_objective__v)
  • Recurrence Based On (recurrence_based_on__v)

Updated the following fields to the Training Requirement (training_requirement__v) object:

  • Estimated Time To Complete (Minutes) (estimated_time_minutes__v). Maximum value is now 1,000,000
  • Duration (duration__v). Maximum value is now 1,000,000

Added the following validation rules to the Training Requirement (training_requirement__v) object:

  • Recurrence Based On must be blank(recurrence_based_on_is_blank__v)

Added the following fields to the Training Assignment (training_assignment__v) object:

  • Object Type (evaluation_training_assignment__v)
  • Evaluation Design(evaluation_design__v)
  • Learning Objectives (learning_objective__v)

Added a new Checklist Type

  • Evaluation Training Assignment Checklist Type (ta_eta_checklisttype__v)

Added the following fields to the Checklist Design Object (checklist_design__sys) object:

  • Object Type (eta_checklist_design__v)

Added the following Application Roles

  • Evaluator (evaluator__v)

Added the following Workflows

  • Complete Evaluation Training Assignment(complete_evaluation_training_assignment__v)

Updated the Training Assignment Lifecycle (training_assignment_lifecycle__v):

  • New Entry Action on the Assigned state
  • New States
    • In Evaluation Preparation (in_evaluation_preparation_state__v)
    • In Evaluation (in_evaluation_state__v)
    • Training On Hold (training_on_hold_state__v)
    • Completed - Not Qualified (completed_not_qualified_state__v)

Added the following fields to the Related Training Assignment (related_training_assignment__v) object:

  • Unique Relationship ID(unique_relationship_id__v)

The following changes were made to support the Station Manager: Capture Document Usage feature:

  • Added the Station Manager Activity (station_manager_activity__v) object

The following changes were made to support the Health Canada Adverse Event Reporting feature:

  • Added the following to the Reportable Event object:
    • New object type: Health Canada (health_canada__v)
    • New fields added to support Adverse Event Reporting for Health Canada
  • Added the following fields to the Organization object:
    • Company Identification No (CA) (ca_company_identification__v)
    • License No (CA) (ca_license_no__v)
  • Added the VPS: Reportability Assessment (reportability_assessment__v) object with the following fields:
    • Medtech Complaint (medtech_complaint__v)
    • Type of Assessment(assessment_type__v)
    • Severity Outcome (severity_outcome__v)
    • Is Reportable? (is_reportable__v)
    • Days for Initial Report Due Date (days_reportable__v)
  • Added the Reportability Assessment Effects (reportability_assessment_effects__v) object with the following fields:
  • Reportability Assessment (reportability_assessment__v)
  • Reportable Event (reportable_event__v)
  • Operation (operation__v)
  • Justification (justification__v)

The following changes were made to support the Assign Effective Version feature:

  • Added the following fields to the Training Requirement (training_requirement__v) object:
    • Assign Additional Training Assignment? (assign_additional_training_assignment__v)
    • Additional Training Assignment Type (additional_training_assignment_type__v)
    • Steady State Content Set Contains (steady_state_content_set_contains__v)
    • In Use Steady State Training Content Set (in_use_steady_state_training_content_set__v)
    • In Use Training Content Set Is Trainable (in_use_tcs_contains_is_trainable__v)
  • Added the following validation rules to the Training Requirement (training_requirement__v) object:
    • Additional TA Type is required (additional_ta_type_is_required__v)
    • Steady State TCS Contains is required ( steady_state_tcs_contains_is_required__v)
  • Added the following fields to the Training Assignment (training_assignment__v) object:
    • Is Additional Training Assignment? (is_additional_training_assignment__v
    • Additional Training Assignment Type (additional_training_assignment_type__v)

The following changes were made to support the Allow Learner Choice for Substitutes feature:

  • Added the following fields to the Training Requirement (training_requirement__v) object:
    • Allow Learner Choice? (allow_learner_choice__v)
    • Substitute Due Date based on (substitute_due_date_based_on__v)
    • Substitute Due Date Override (substitute_due_date_override__v)
  • Added the following fields to the Training Assignment (training_assignment__v) object:
    • Learner Choice Made? (learner_choice_made__v)

The following changes were made to support the Enhanced Periodic Review for Documents feature:

  • Added a new Periodic Review (periodic_review__v) object with the following fields:
    • Cancelled / Not Started Reason (cancelled_notstarted_reason__v)
    • Document Lifecycle (document_lifecycle__v)
    • Governing Change Control (governing_change_control__v)
    • Job ID (job_id__v)
    • Periodic Review Workflow (periodic_review_workflow__v)
    • Periodic Review Workflow State (periodic_review_workflow_state__v)
    • Target Document (target_document__v)
  • Added a new Periodic Review Lifecycle (periodic_review_lifecycle__v) with the following standard states:
    • Cancelled (cancelled_state__v)
    • Complete (complete_state__v)
    • Created (created_state__v)
    • Inactive (inactive_state__v)
    • Initiated (initiated_state__v)
    • Keep Effective (keep_effective_state__v)
    • Make Obsolete (make_obsolete_state__v)
    • Needs Revision (needs_revision_state__v)
    • Not Started (not_started_state__v)
  • Added two new shared document fields:
    • Current Periodic Review (current_periodic_review__v)
    • Current Periodic Review Workflow (current_periodic_review_wf__v)

The following changes were made to support the Batch Release Process Support feature:

  • Added a new Batch / Lot Disposition (lot_disposition__v) object with the following fields:
    • Lot (lot__v)
    • Country (country__v)
    • Governing Change Control(governing_change_control__v)
    • Certificate of Analysis (coa_doc__v)
    • Certificate of Compliance(coc_doc__v)
    • Specification Document (specification_doc__v)
    • Usage Decision(usage_decision__v)
  • Added a new Lot Disposition Input (lot_disposition_input__v) object with the following fields:
    • Check Accepted (check_accepted__v)
    • Description (check_description__v)
    • Lot Disposition (lot_disposition__v)
    • Document (lot_dispo_doc__v)
  • Added a new Disposition Input Quality Event (lot_disp_input_qe__v) object with the following fields:
    • Lot Disposition Input (lot_disposition_input__v)
    • Quality Event (quality_event__v)
    • Impact on Lot Disposition (lot_disp_impact__v)
  • Added a new Lot Disposition Lifecycle (lot_disposition_lifecycle__v)
  • Added a new Lot Disposition Input Lifecycle (lot_disposition_input_lifecycle)

The following changes were made to support the Generate Quality Document from Record Action feature:

  • Added new shared document fields:
    • Audit Record (audit_record__v)
    • Quality Event Record (quality_event_record__v)

The following changes were made to support the Relationship Automation for Quality Objects (QE, Audits, CAPA) feature:

  • Added a new standard Picklist: Relationship Natures (qms_relationship_natures__v)
  • Added a new Related CAPA (related_capa__v) object with the following fields:
    • Parent CAPA (parent_capa__v)
    • Related CAPA (related_capa__v)
    • QMS Record Relationship Nature (qms_rec_rel_nature__v)
    • Reciprocal Link id (reciprocal_link_id__v)
    • Create reciprocal link error reason (recip_auto_error__v)
  • Updated the Related Quality Event (related_quality_event__v) object with the following fields:
    • QMS Record Relationship Nature (qms_rec_rel_nature__v)
    • Reciprocal Link id (reciprocal_link_id__v)
    • Create reciprocal link error reason (recip_auto_error__v)
  • Updated the Related Audit (related_audit__v) object with the following fields:
    • QMS Record Relationship Nature (qms_rec_rel_nature__v)
    • Reciprocal Link id (reciprocal_link_id__v)
    • Create reciprocal link error reason (recip_auto_error__v)

In QualityDocs vaults, the Do Not Copy attribute was set to True on the Release Change Control (release_change_control__v) and Obsolete Change Control (obsolete_change_control__v) document fields.