Create an Investigation

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

For Major or Critical internal Deviations, the Deviation record is managed in four (4) main stages: assessment, approval, investigation, and final approval & closure.

When a Major or Critical internal Deviation reaches the investigation stage, Vault assigns a task to the Deviation Owner. At least one Investigation is required to be created and completed for Major and Critical internal Deviations.

Complete the following steps to create an Investigation:

  1. Access the Deviation from the assigned task.

    Screenshot step 1

  2. Click the Investigations section, then click Create.

    Screenshot step 2

  3. Enter the Title of the Investigation.

    Screenshot step 3

  4. Enter a detailed Description of the Investigation.

    Screenshot step 4

  5. Select the Investigation Category.

    Screenshot step 5

  6. Select the Owning Department responsible for conducting the deviation.

    Screenshot step 6

  7. Click Save. Vault assigns the Investigation a Record Number, creates the Investigation record with a status of Define Team, and opens the Investigation page.

    Screenshot step 7

  8. In the Team section, click Manage Team.

    Screenshot step 8

  9. Select the Owner responsible for conducting the investigation, then click Save. Vault updates the Investigation status to In Investigation and assigns a Complete Investigation task to the Investigation Owner.

    Screenshot step 9