Manage CAPA Line Investigation
Explanation
This activity is used for investigating a CAPA line and releasing it for
action completion. A person responsible for investigating is identified and a
target date is set, then the investigator will add notes and set the status to
Investigated.
This activity contains a security checkpoint that can be activated by an
administrator. With an activated security checkpoint on a function it is needed
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
Released status.
System Effects
As a result of this activity, the status of the CAPA line is changed to Investigated.
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 Investigation Data link to work from a dialog, or
fill in the fields on the line.
- In the
Investigation Responsible ID field, enter the ID of a responsible person or click
List to select a value from the List of Values. Entering a value in
this field is required.
- Enter a value in the Target Investigation Date field. Entering a
value in this field is required.
- In the Investigation Notes field, enter a note. Entering a value
in this field is required.
- In the
Action Responsible ID field, enter the ID of a responsible person or click
List to select a value from the List of Values. Entering a value in
this field is required.
- Enter a value in the Target Action Date field. Entering a value
in this field is required.
- Click OK.
- Right-click and then click Investigate. The status of the corrective and preventive action record changes to
Investigated. The system generates a time stamp for the investigation
date as well as for the person who made the system state change.
Corrective and Preventive Actions window
- In the
Investigation Responsible ID field, enter the ID of a responsible person or click
List to select a value from the List of Values. Entering a value in
this field is required.
- Enter a value in the Target Investigation Date field. Entering a
value in this field is required.
- In the Investigation Notes field, enter a note. Entering a value
in this field is required.
- In the
Action Responsible ID field, enter the ID of a responsible person or click
List to select a value from the List of Values. Entering a value in
this field is required.
- Enter a value in the Target Action Date field. Entering a value
in this field is required.
- Click OK.
- Right-click and then click Investigate. The status of the corrective and preventive action record changes to
Investigated. The system generates a time stamp for the investigation
date as well as for the person who made the system state change.
Note: if you want to revoke the investigation, you can right-click and
then click Release. The
Investigated Date and
Investigated By
fields will be cleared.