Setting enhanced manual test run compliance project options

Enabling enhanced compliance for manual test runs can help make sure that tests meet compliance requirements, such as 21 CFR 11, and that your team's testing process is followed.

If you enable enhanced manual test run compliance:

  • Manual test runs are always generated in detail grid view, which guides testers through each step of the manual test run and helps testers capture additional information that is not available in grid or text view, such as entering actual test results on each step and indicating the result of each step (Pass, Fail, or Undetermined). See Entering manual test results in detail grid view. Existing manual test runs generated in grid or text view are not changed to detail grid view.
  • You can enforce rules that manual test runs must meet before an action is performed on them. For example, you can require that all steps in a manual test runs must pass before the overall result is entered. Rules are only applied to manual test runs generated in detail grid view.
The following information uses the default terminology for manual test runs, such as Pass, Fail, and Undetermined for test results. Your team may use different terminology.

1. Choose Tools > Administration > Project Options.

The Project Options dialog box opens.

2. Select Manual Test Runs from the Compliance category. 

3. Select any logging or electronic signature options. See Setting item compliance project options.

4. Select Enable enhanced compliance to require all manual test runs to be generated in detail grid view and apply any selected rules to manual test runs before they are saved.

5. Select any Rules.

If a manual test run does not pass the selected rules when it is saved or a workflow event is entered to indicate the overall test result, an error is displayed that explains why the action cannot be performed.

  • All steps must have a step result before the manual test run can be passed or failed requires that all steps have a Pass, Fail, or Undetermined result before the overall manual test run result is set to Pass or Fail.
  • All steps must pass before the manual test run can be passed requires that all steps have a Pass result before the overall manual test run result is set to Pass.
  • The manual test run cannot be passed if any steps fail requires that no steps have a Fail result before the overall manual test run result is set to Pass. It does not require that all steps have a result.
  • A problem statement is required for each step that fails requires that steps with a Fail result have a problem statement before the manual test run is saved.
  • The actual results field is required for steps that have a step result of pass or fail requires that text or an attachment is added to the Actual Results field before the step result is set as Pass or Fail.
  • Issues must be linked to the manual test run if the manual test run fails requires that the manual test run is linked to an issue before the overall manual test run result is set to Fail. This option is only available if an item mapping rule for creating issues from a manual test run is configured. See Configuring item mapping rules.

6. Select The step result field can be set to undetermined to allow a manual test run step result to be set to Undetermined in addition to Pass or Fail.

Clearing this option does not automatically remove the Undetermined result from manual test run steps. Manual test runs must be manually updated.

7. Click OK to save the changes.