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:
Access the Deviation from the assigned task.
Click the Investigations section, then click Create.
Enter the Title of the Investigation.
Enter a detailed Description of the Investigation.
Select the Investigation Category.
Select the Owning Department responsible for conducting the deviation.
Click Save. Vault assigns the Investigation a Record Number, creates the Investigation record with a status of Define Team, and opens the Investigation page.
In the Team section, click Manage Team.
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.