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If any effectiveness measure indicates reoccurrence of the listed root cause inside the timeline for effectiveness monitoring, the CAPA record is marked ineffective and closed. An email is sent to the CAPA owner.
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At any time, you can click Save and continue working on the CAPA later.
Use the step navigator at the top of the screen to quickly move to a different step in the procedure.
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Name
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Value
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Action ID
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The action ID specified in a previous workflow step.
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Action Type
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The action type specified in a previous workflow step.
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Primary Site
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The primary site specified in a previous workflow step.
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Effectiveness Approval Required
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The type of effectiveness approval specified in a previous workflow step.
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Effectiveness Start Date
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The effectiveness start date specified in a previous workflow step.
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Effectiveness End Date
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The effectiveness end date specified in a previous workflow step.
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Effectiveness Measure
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The effectiveness measure specified in a previous workflow step.
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Outcome
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Required. Use the list to select an Outcome:
• Effective: The proposed measure prevented the reoccurrence of the issue.
• Not Effective: The proposed measure did not prevent the reoccurrence of the issue.
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Effectiveness Comment
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Enter text to describe the effectiveness of the outcome, if necessary.
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