Manage CAPA Line Effectiveness Evaluation

Explanation

This activity is used to manage the evaluation of the effectiveness of a CAPA line, and is usually done when a specified amount of time is elapsed since the CAPA line has been verified. The person responsible for the effectiveness evaluation adds notes and finally sets the status to Effectiveness Determined.

This activity contains a security checkpoint which can be activated by an administrator. With an activated security checkpoint on a function it is necessary to authenticate the user again in order to fulfill the function. Additionally, whenever a security checkpoint is successfully passed, a security checkpoint log is written creating an audit trail of what is done.

Prerequisites

A Corrective and Preventive Action line should exist in the Verified status.

System Effects

Window

Corrective and Preventive Action
Corrective and Preventive Actions

Related Window Descriptions

Corrective and Preventive Action
Corrective and Preventive Actions

Procedure

Corrective and Preventive Action window

  1. Click the Actions tab and select a record.
  2. Click the Enter Effectiveness Data link to work from a dialog, or fill in the fields on the line.
  3. Enter an appropriate note in the Effectiveness Notes field. Entering a value in this field is mandatory.
  4. Click OK.
  5. Right-click and then click Determine Effectiveness. The status of the CAPA line changes to Effectiveness Determined. The system generates a time stamp for the effectiveness determined date as well as for the person who made the system state change.

Corrective and Preventive Actions window

  1. Enter an appropriate note in the Effectiveness Notes field. Entering a value in this field is mandatory.
  2. Click OK.
  3. Right-click and then click Determine Effectiveness. The status of the CAPA line changes to Effectiveness Determined. The system generates a time stamp for the effectiveness determined date as well as for the person who made the system state change.

Note: if you want to revoke the effectiveness evaluation of an action, you can right-click and then click Verify. The Effectiveness Date and Effectiveness By fields will be cleared. If the corrective or preventive action is closed, you need to reopen it first.