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CAPA: Under Signing by QA

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Editing a CAPA while in Under Signing by QA status 

Once a CAPA reaches Under Signing by QA it can no longer be edited.

 

Changing status from Under Signing by QA 

QA basically has 3 options at this point:

  • Closing the CAPA without requiring an Effectiveness Check.
  • Closing the CAPA requiring Effectiveness Check.
  • Rejecting the CAPA.

 

Closing the CAPA without requiring Effectiveness Check

  1. In the CAPA Details Page, click on the Under Signing by QA status button.
  2. Set to Closed.

 

In the Set to Closed window QA must then:

  1. Introduce electronic signature credentials: User and Password. 
  2. Submit a Statement for closing the CAPA.
  3. Set Effectiveness Check Required to No.
  4. Sign.

 

The system will then give the following notification: CAPA signed successfully by QA. Status updated to Closed.

If there is more than one QA and the Sign off by all QA persons required switch has been turned ON in Module Settings, then all QA persons must sign off before the CAPA is Closed.

 

Closing the CAPA requiring an Effectiveness Check

  1. In the CAPA Details Page, click on the Under Signing by QA status button.
  2. Set to Closed.

 

In the Set to Closed window QA must then:

  1. Introduce electronic signature credentials: User and Password. 
  2. Submit a Statement for closing the CAPA.
  3. Set Effectiveness Check Required to Yes.
  4. Give an Effectiveness Check Description.
  5. Set an Effectiveness Check Due Date.
  6. Sign.

 

The system will then give the following notification: CAPA signed successfully by QA. Status updated to Effectiveness Check Pending.

If there is more than one QA and the Sign off by all QA persons required switch has been turned ON in Module Settings, then all QA persons must sign off before the CAPA is set to Effectiveness Check Pending.

 

Rejecting the CAPA

  1. In the CAPA Details Page, click on the Under Signing by QA status button.
  2. Set to Reject as QA.

 

In the CAPA Reject window QA must then:

  1. Give a Reason for Rejecting the CAPA.
  2. If relevant, QA can indicate which Custom Actions need to be reopened. When clicking on the Select Custom Actions field, all available Custom Actions will appear, QA can select the ones that need to be reopened.
  3. If relevant, QA can indicate which Action Documents need to be reopened. When clicking on the Action Documents field, all available Update Document Actions will appear, QA can select the ones that need to be reopened.
  4. Save changes.

 

The system will then give the following notification: CAPA Updated successfully.

If there is more than one QA it is only necessary for one of them to reject the CAPA and it will go back to Implementing status.

 
Please note:
  • Update Documents Actions usually include more than one Document, since the Update Documents Action can only be selected as a whole in the Actions Documents field this means that, if selected, all Documents included in the Update Documents Action would need to be updated again. Alternatively, once the CAPA is rejected and goes back to Implementing Status, QA can add an Additional Update Documents to the CAPA and include only the exact Documents that need to be updated again in this new Update Documents Action.

 

  Relevant for: Administrators / Managers / Regular Users.

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