High Level CAPA (Corrective Action Preventive Action) SOP Example Needed

Calico

Inactive Registered Visitor
#1
Hi All,

I searched through many CAPA threads but it's a bit overwhelming!

I'm new to the Cove and am working for a medical device company. We are re-writing all the company's high level "SOP's" which right now are basically more procedures and work instructions. There is a lot of confusion as to how much information should go into a high level SOP. I've been given a new CAPA SOP that (to me) has way too much information in it and was wondering if anyone had a high level SOP that they could share?:confused:

Thanks,
Callie:
 

egarry

Inactive Registered Visitor
#3
Hi All,

I searched through many CAPA threads but it's a bit overwhelming!

I'm new to the Cove and am working for a medical device company. We are re-writing all the company's high level "SOP's" which right now are basically more procedures and work instructions. There is a lot of confusion as to how much information should go into a high level SOP. I've been given a new CAPA SOP that (to me) has way too much information in it and was wondering if anyone had a high level SOP that they could share?:confused:

Thanks,
Callie:
I have combined the CA and PA procedures for years. I think that a balance is important for high level SOPs. Enough information so everyone understands the process but not too complicated which handcuffs managements ability to use the system for a wide array of issues.
I have attached a example of a CAPA procedure which could give you some ideas.
Good luck.:bigwave:
 

Attachments

Calico

Inactive Registered Visitor
#4
Thanks so much, that is actually perfect. We have our CA/PA combined as well and the SOP that someone wrote is like a book. Your example is much appreciated:biglaugh:

Best Regards,
Callie
 
M

mudumbaiharikiran

#6
hi, i am a student studying MS from swinburne university, i am new to these topics. can anyone please post an example sop of CAPA giving a pharmaceutical example?
thank you
 

harry

Super Moderator
#7
hi, i am a student studying MS from swinburne university, i am new to these topics. can anyone please post an example sop of CAPA giving a pharmaceutical example?
thank you
Go to the 'post attachments list' (thin green bar within the header bar and at the top left hand corner of every page) and do a search using 'capa', 'corrective action' or 'preventive action'.
 

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