Configuring System Suitability Testing

System Suitability Testing allows Lab Analysts to perform tests on Quality Control Samples alongside normal Lab Samples in order to confirm that the lab’s systems are functioning as expected and providing accurate results. Configuring this feature for use requires setup by a Vault Admin.

Configuration Steps

In order to enable System Suitability Testing, a Vault Admin must complete the following steps:

  1. Navigate to Admin > Configuration > Object Lifecycles > Lab Test Set Lifecycle and add a new workflow user action called Invalidate Workflow to the following states:
    1. In Progress
    2. In Verification
  2. Navigate to Admin > Configuration > Objects and make changes to the following objects:
    1. Lab Sample: Activate the Quality Control Sample object type.
    2. Lab Test Set:
      1. Enable the Enable Signatures option.
      2. On the Actions tab, ensure that the Begin Test and Resume Test actions are set to the Active status.
      3. On the Page Layout tab:
        1. Add the following fields to the Details section: Test Definition, Conforms, Non Conforming Sample Type
        2. Add the following additional fields: Invalid, New Test Set, Previous Test Set, Invalid Reason, Invalid Reason Category. Optionally, you can create a new section called Invalid Test Set or something similar to house these fields.
        3. Remove the Test Instructions field.
        4. Add a new Spec Execution related object section.
        5. Inactivate the layout rule that hides the Workflow Timeline section.
        6. Add a new Lab Test Set Result related object section.
  3. Return to Admin > Configuration > Object Lifecycles > Lab Test Set Lifecycle and complete the following steps:
    1. In the Roles section, add the Contributed to Test Execution role. Without this, users who update Inputs or Lab Test Results, or Lab Test Set Results are not added to the role.
    2. On the Active state, add the Begin Test user action.
    3. On the In Progress state, add the Resume Test user action.
    4. On the In Review State, add the Review Lab Test user action. This allows the reviewer to perform the workflow from this state.
    5. On the Rejected state, add an entry action that performs the following operations:
      1. Change state to Rejected for records that are related by Lab Tests.
      2. Set the Invalid field to true using a formula. This also updates the Invalid field for Test Set Results and Test Set Results Criteria.
      3. Change the Spec Execution Related Object Lifecycle state to Rejected if the Lifecycle state is not Logged. This changes the Spec Execution for the QC Sample to Rejected. The Logged state ensures that Operational Criteria Spec Execution is not erroneously moved to the Rejected state.
  4. Navigate to Admin > Configuration > Object Lifecycles > Spec Execution Lifecycle and complete the following steps:
    1. On the Rejected state, add an entry action that performs the following operations:
      1. If Spec Execution Type equals Quality Control Sample, change the Lab Sample’s state to Rejected.
  5. Navigate to Admin > Configuration > Objects and make changes to the following objects:
    1. Spec Execution
      1. Activate the Quality Control Sample object type.
      2. On the Layouts tab, add the Test Set field to the page layouts for the Operational Criteria and Quality Control Sample object types.
    2. Spec Data
      1. On the Layouts tab, add a Lab Test Definition Criteria section to the layouts for the Batch Release and Stability object types.
    3. Spec Data Sample Action
      1. On the Fields tab, add a Lab Test Definition Variation object field with the following VQL criteria: qc_sample_type__v = null
    4. Lab Test
      1. On the Lab Sample field, add the following VQL criteria: object_type__vr.name__v != 'quality_control_lab_sample__v'
    5. Lab Test Definition Criteria
      1. On the Layouts tab:
        1. Add layout rules to hide fields if variation exists. (These should mimic the Spec Data Criteria layout rules: hide for variations, hide for no variations.)
        2. Create new layouts for the Operational Criteria and Quality Control Sample Criteria object types. Mimic the Spec Data Criteria layout and layout rules.
        3. Add a Criteria formula field.
        4. Add a Version History control section.
        5. Add a Variation Result to Evaluate field.
        6. Add the following layout rules:
          1. Rounding Rule if(not(isBlank(lims_variation_result_to_evaluate__v)),lims_variation_result_to_evaluate__vr.rounding_rule__v,lims_result_to_evaluate__vr.rounding_rule__v)
          2. Precision Type if(not(isBlank(lims_variation_result_to_evaluate__v)),lims_variation_result_to_evaluate__vr.precision_type__v,lims_result_to_evaluate__vr.precision_type__v)
          3. Precision if(not(isBlank(lims_variation_result_to_evaluate__v)),lims_variation_result_to_evaluate__vr.precision_number__v,lims_result_to_evaluate__vr.precision_number__v)
          4. Notation lims_result_to_evaluate__vr.notation__v
      2. On the Fields tab:
        1. Configure the following picklist dependencies:
          1. Indication: Only Alert for the Test Definition Criteria object types, Operational Criteria and Quality Control Sample Criteria.
          2. Purpose: Internal. Internal is also set as the default value.
        2. On the Result to Evaluate field, add the following VQL criteria:
          1. Quality Control object type: result_level__v != 'test_set__v'
          2. Operational Criteria object type: result_level__v = 'test_set__v'
          3. Set the Name field as system managed.
  6. Activate the standard picklist values for Purpose and delete the custom picklist values.
  7. Return to to Admin > Configuration > Objects and make the following changes:
    1. Lab Test Definition: On the Layouts tab, add Lab Test Definition Criteria as a related object section.
    2. Lab Test Definition Variation:
      1. On the Layout tab:
        1. Add Lab Test Definition Criteria as a related object section.
          1. Add the following VQL criteria and click Apply on Create: object_type__vr.api_name__v = 'qc_sample_criteria__v'
        2. Add the following layout rules:
          1. Hide QC sample type
            1. Expression: mode_of_entry__v != 'test_execution__v'
            2. Hide: Lab Test Definition Criteria section and QC Sample Type field
          2. Hide criteria for non-QC sample type
            1. Expression: isBlank(qc_sample_type__v)
            2. Hide: Lab Test Definition Criteria section
    3. Lab Sample:
      1. On the Object Types tab:
        1. Assign custom fields (like state_c) to the Quality Control Lab Sample object type.
        2. Set the Quality Control Lab Sample object type to Active.
        3. Override the Quality Control Sample Type picklist to add all picklist values to the QC Sample object type.
      2. On the Layouts tab:
        1. Add a new Quality Control Lab Sample page layout.
          1. Activate the Lab Sample Name field.
  8. Configure the following Atomic Security for the Test Set Lifecycle:
    1. Active state: Begin Test action role override: Editor, LIMS Lab Analyst
    2. In Progress state: Begin Test action role override: Editor, LIMS Lab Analyst
    3. Roles: READ to LIMS Analyst
  9. Update the following Permission Sets:
    1. LIMS User
      1. READ and EDIT: Lab Sample object > Quality Control Sample object type
      2. READ: Lab Test Definition Criteria object > Quality Control Sample Criteria and Operational Criteria object types
      3. READ: Spec Execution object > Quality Control Sample and Operational Criteria object types
    2. LIMS Results Data Entry (If needed)
      1. EDIT: Invalid Reason and Invalid Category fields on the Lab Test Set object
    3. Design Data Admin
      1. VIEW: Test Definition Version History control and Criteria control on the Lab Test Definition Criteria object
      2. VIEW: Lab Test Definition Criteria object control on the Spec Data object