Manage CAPA Line Verification

Explanation

This activity is used to manage the verification of the CAPA line. A person responsible for evaluating the effectiveness of the action is identified and a target date is set, then the person responsible for the verification will add notes and set the status to Verified.

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 CAPA line must exist in the Completed status.

System Effects

As a result of this activity, the status of the CAPA line changes to Verified.

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 Verification Data link to work from a dialog, or fill in the fields on the line.
  3. In the Verification Notes field, enter an appropriate note. Entering a value in this field is required.
  4. In the Effectiveness Responsible ID field, enter the ID of the person responsible for determining the effectiveness. Entering a value in this field is required.
  5. In the Target Effectiveness Date field, enter a target date for determining effectiveness. Entering a value in this field is required.
  6. Click OK.
  7. Right-click and then click Verify. The status of the corrective and preventive action record changes to Verified. The system generates a time stamp for the verification date as well as for the person who made the system state change.

Corrective and Preventive Actions window

  1. In the Verification Notes field, enter an appropriate note. Entering a value in this field is required.
  2. In the Effectiveness Responsible ID field, enter the ID of the person responsible for determining the effectiveness. Entering a value in this field is required.
  3. In the Target Effectiveness Date field, enter a target date for determining effectiveness. Entering a value in this field is required.
  4. Click OK.
  5. Right-click and then click Verify. The status of the corrective and preventive action record changes to Verified. The system generates a time stamp for the verification date as well as for the person who made the system state change.

Note: If you want to revoke the verification, you can right-click and then click Action. The Verification Date and Verified By fields will be cleared.