Investigate a Major or Critical Internal Deviation

Who can complete this task? Veeva Quality Basics: Deviation Owner

When a Major or Critical Deviation receives its initial QA approval, Vault assigns the Deviation Owner a Complete Investigation & CAPA Plan task. To complete the task, document the required information regarding the Deviation investigation.

To document Deviation investigation details:

  1. Access the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions.
  2. Expand the Details section and click Edit () on the action bar. 
  3. In the Details section, review and adjust the Rating if needed.
  4. Expand the Impact & Risk Analysis section and enter details regarding the impact of the Deviation and the risk analysis performed. 
  5. Expand the Investigation Summary & Conclusion section and enter the results of the investigation.
  6. Expand the Plan Details section.
  7. For the CAPA Required field, select whether a CAPA Action is required:
    • Select Yes if a CAPA Action must be completed as a result of the Deviation. The CAPA Actions section is displayed and at least one CAPA Action must be created before the Deviation investigation can be approved.
    • Select No if a CAPA Action is not required. In the Rationale for No CAPA field, enter the justification for why a CAPA Action is not required.
  8. For the Effectiveness Check Required field, select whether an Effectiveness Check is required:
    • Select Yes if an Effectiveness Check must be completed as a result of the Deviation. The Effectiveness Checks section is displayed and at least one Effectiveness Check must be created before the Deviation investigation can be approved.  
    • Select No if an Effectiveness Check is not required. In the Rationale for No Effectiveness Check field, enter the justification for why an Effectiveness Check is not required. 
  9. Click Save to save the Deviation information.

Create an Investigation

At least one Investigation is required to be created and completed for Major and Critical Deviations.

Complete the following steps to create an Investigation:

  1. Expand the Investigations section and click Create. The Create Investigation page is displayed.
  2. Enter the Title of the Investigation.
  3. Enter a detailed Description of the Investigation.
  4. Select the Investigation Category.
  5. Select the Owning Department responsible for conducting the deviation.
  6. Click Save. Vault assigns the Investigation a Record Number, creates the Investigation record with a status of Define Team, and opens the Investigation page.
  7. Expand the Team section and click Manage Team.
  8. Select the Owner responsible for conducting the investigation.
  9. Click Save to save the selected Owner. Vault updates the Investigation status to In Investigation and assigns a Complete Investigation task to the Investigation Owner.

Complete an Investigation

When the Deviation Owner creates an Investigation, Vault assigns the Investigation Owner a Complete Investigation task. To complete the task, conduct the investigation and document the results. 

If you need additional time to complete an Investigation, create an Extension Request to request a later due date.

Complete the following steps to complete an Investigation:

  1. Access the Investigation from the assigned task. Vault opens the Investigation and displays a task banner with the task due date and instructions.
  2. Expand the Results section and click Edit () on the action bar. 
  3. In the Results section, enter the results of the investigation.
  4. Click Save to save the results.
  5. Optional: Add Library References or Attachments as needed.
  6. Click Complete in the Complete Investigation task banner to open the Complete Investigation dialog.
  7. Click Complete in the dialog. Vault updates the Investigation status to Investigation Completed.