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
- Click the Actions tab and select a record.
- Click the Enter Verification Data link to work from a dialog, or
fill in the fields on the line.
- In the
Verification Notes field, enter an appropriate note. Entering a value
in this field is required.
- 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.
- In the Target Effectiveness Date field, enter a target date for
determining effectiveness. Entering a value in this field is required.
- Click OK.
- 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
- In the
Verification Notes field, enter an appropriate note. Entering a value
in this field is required.
- 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.
- In the Target Effectiveness Date field, enter a target date for
determining effectiveness. Entering a value in this field is required.
- Click OK.
- 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.