22R3 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 22R3.

Data Model Updates

To support the Duplicate Detection Check feature available for Quality Event: Complaints and MedTech Complaints as well as standalone Complaints, added the following new components:

  • A standard Record Check Rule Detail object
  • A Complaint object reference field on the Record Check Result object
  • A Complaint object reference field, a Record Check Rule Detail object reference field, and an Is Original boolean field to the Record Check Match Record object

Added the following standard components to support the Batch Release Templates & Automation feature:

  • Objects:
    • Batch Release Template (batch_release_template__v)
    • Batch Release Template Item (batch_release_template_item__v)
    • Quality Event - Batch (quality_event_batches__v)
    • Quality Event - Material (quality_event_material__v)
    • Lot Disposition Input - Document (lot_disposition_input_document__v)
  • Lifecycles
    • Batch Release Template Lifecycle (batch_release_template_lifecycle__v)
    • Quality Event - Batch Lifecycle (quality_event_batch_lifecycle__v)
    • Quality Event - Material Lifecycle (quality_event_material_lifecycle__v)

Added the following field to both the Quiz Checklist Design object type of the Checklist Design object and the TA Checklist object to support the Quiz: Hide Missed Questions feature:

  • Hide Missed Questions (hide_missed_questions__v)

Made the following changes to support the Instructor-Led Training: Simplified Experience feature:

  • New fields on Class Schedule object:
    • Updated UI (updated_ui__v)
    • Class Completion Date (class_completion_date__v)
    • Past Class (past_class__v)
  • New field on Class Roster object:
    • Class Completion Date (class_completion_date__v)
  • New picklist value for the class_completion_status__v picklist
    • Pending Quiz Completion (pending_quiz_completion__v)
  • New Lifecycle State on Class Schedule object
    • Published (published_state__v)
  • New System-Provided Application Role
    • Instructors (instructor__v)

Made the following changes to support the Option Not to Issue Quiz for Document Revision Training feature:

  • New fields on Training Requirement Impact Assessment object:
    • Study (study__v)
    • Exclude Quiz for Doc Revision Training (exclude_quiz_for_doc_revision_training__v)
  • New fields on Training Requirement object:
    • Exclude Quiz for Doc Revision Training (exclude_quiz_for_doc_revision_training__v)

Made the following changes to support the Disallow Quiz Design Population for Classroom Training Requirements feature:

  • New Validation Rule on Training Requirement:
    • Quiz Design Not Allowed On Classroom TR (quiz_not_allowed_classroom_training__v)

Made the following changes to support the Training Matrix Builder feature:

  • New fields on Learner Role-Person object:
    • Start Date (start_date__v)
    • End Date  (end_date__v)
  • New Objects:
    • Study Team Role (study_team_role__v)
    • Learner Role-Study (study_learner_role__v)

The following components were added to support the Complaints: Relationship Automation, Recurrence Check, & Checklist Support feature:

  • Complaint Checklist (complaint_checklist__sys)
  • Complaint Dependency (complaint_dependency__sys)
  • Complaint Sub-Checklist (complaint_subchecklist__sys)
  • Complaint Checklist Design (complaint_checklist_design__sys) object type on Checklist Design Object

The following components were added to support the Set From Email Attributes on Complaint Emails feature:

  • From (from__v) on Complaint Sent Notification object
  • From (from__v) on Quality Event Sent Notification object
  • Complaint (complaint__v) field on Record Check Result object
  • Related Complaint (related_complaint__v) field on Record Check Match Record object
  • From Email Address (from_email_address__v) object type on Person object

The following components were added to Quality Vaults to support the Lab Test Set, Lab Sample, & Batch Review as well as the Making Revisions to Lab Results feature in Vault LIMS:

  • Added new fields to the Lab Result object:
    • Actual Data Entry Method
    • Change Reason
    • Revisions
    • Out of Specification
    • Previously Out of Specification
    • Out of Control
    • Change Reason
    • Revisions
  • Added new fields to the Lab Test object:
    • Revisions
    • Out of Specification
    • Previously Out of Specification
    • Out of Control
    • Override
  • Added new fields to the Lab Sample object:
    • Revisions
    • Out of Specification
    • Previously Out of Specification
    • Out of Control
    • Override
    • Additions
    • Disposed of Date
  • Added new fields to the Batch object:
    • Override
    • Revisions
    • Out of Specification
    • Previously Out of Specification
    • Out of Control
    • Override
    • Actual Data Entry Method
    • Additions
  • Added new objects:
    • Lab Result History (lims_result_history__v)
    • Lab Result Signature (lims_result_sig__sys)
  • Added new standard lifecycle for Lab Result History object:
    • Lab Result History Lifecycle (lims_result_history_lifecycle__v)
  • Added new picklists:
    • Lab Result Signature Type (lims_result_sig_type__sys)
    • Lab Result Change Reason (lab_result_change_reason__v)
  • Added new state types:
    • Committed (committed_state_type__v)
    • In Review (in_review_state_type__v)
    • Reviewed (reviewed_state_type__v)
  • Added new standard workflow:
    • Lab Result Change (lims_lab_result_change__v)