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

A

alias9

#1
Hi,

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

Regards
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#4
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.
 
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