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Can change control can be closed if the CAPA is still open?
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Can change control can be closed if the CAPA is still open?
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  Post Number #1  
Old 17th April 2018, 05:26 AM
alias9

 
 
Total Posts: 3
Question Can change control can be closed if the CAPA is still open?

Hi,

Can anyone please confirm if the change control can be closed if the CAPA is still open?

Regards

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  Post Number #2  
Old 17th April 2018, 06:15 AM
invitro_spain's Avatar
invitro_spain

 
 
Total Posts: 71
re: Can change control can be closed if the CAPA is still open?

Please, more details.
  Post Number #3  
Old 17th April 2018, 07:08 AM
rjhill

 
 
Total Posts: 11
re: Can change control can be closed if the CAPA is still open?

Every companies system is different, you need to give a lot more information.
  Post Number #4  
Old 17th April 2018, 12:05 PM
BradM's Avatar
BradM

 
 
Total Posts: 6,016
Re: Can change control can be closed if the CAPA is still open?

Hi there!

As the other suggested, this is fairly broad and can go either way.

As a general rule, I would state that the Change Control needs to be completed before the CAPA can be closed. The CAPA is what guided the Corrective Action; which I'm assuming in your case, initiated the Change Control. The Change Control is closed whenever the specified/ approved change is completed.

However, if the CAPA ensued by some action/observation while executing the Change Control, then the CAPA may need to be closed prior to completing the Change Control.

It all depends on... which action led (or followed) the other action; and what is allowed/dictated by your process.

Some Change Control process allow for partial release/ close with exception; others require all actions complete.
Thanks to BradM for your informative Post and/or Attachment!
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