- Veeva Quality Basics: Deviation Owner
Effectiveness Checks allow you to monitor the effectiveness of a change after it is implemented. In the case of a Deviation, an Effectiveness Check evaluates the effectiveness of the CAPA plan.
To create an Effectiveness Check:
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In the Change Control or Deviation record, click Effectiveness Checks, then click Create.
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Enter the Title of the Effectiveness Check.
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Enter a Description of the activities required to check for effectiveness of the executed plan.
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Enter the Start Date on which Vault will automatically initiate the Complete Effectiveness Check task. We recommend entering a Start Date later than the Change Control or Deviation Current Due Date, because Effectiveness Checks are completed after the associated Change Control or Deviation is closed.
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Enter the Current Due Date, which is the date the Effectiveness Check must be completed and approved.
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Click Save to save the record and open the Effectiveness Check page.
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In the Team section, click Manage Team.
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Select the Owner responsible for completing the effectiveness check and one or more QA Approvers responsible for approving the effectiveness check completion. A QA Approver cannot be the same user as the Owner. Vault defaults the QA approver(s) to those already on the Deviation team.
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Click Save to save the selected team members. Vault updates the Effectiveness Check status to Initiated.
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Optional: Add Library References or Attachments as needed.
