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Software and Methods for Tracking CAPA (Corrective and Preventive Action) items

JJ_FDA

Involved In Discussions
#1
What software do you use to manage internal inspection findings and responses to findings?

I would like to be able to track findings, response to findings including commitments to CAPAs made by operations (e.g., will write and implement SOP x by date y), to trend finding types (e.g., are the number of findings for poor documentation increasing?), and to cross-reference findings / CAPAs.

Currently, I am writing up a report, collecting response to findings made by operations in the report, then transcribing things into a spreadsheet, manually cross-referencing things, and eyeballing trends by using filters and sorts.

It's really not efficient. Moreover, it strikes me that this kind of information belongs in a database rather than a spreadsheet.
 
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Mike S.

Happy to be Alive
Trusted Information Resource
#2
The purchased software my company uses for RCCA tracking is bloody awful. But I have seen some homemade Access databases work really well because the user customized it to their needs.

My advice is try out any commercial product very carefully before committing lots of cash to it. And consider creating your own.
 

JJ_FDA

Involved In Discussions
#3
Thanks Mike! Advice on what software to avoid is just as valuable as what software to consider.

I'm thinking of having a database done in house as well, but would prefer a COTS as it may be faster to implement.
 
K

Kevin_Emmrich

#4
There seems to be a lot of corrective action software out there if you google "Corrective Action Software". Hmmm, we don't show up until page 2 -- and we just replaced our server and it looks like some older pages are out there! Thanks for making me check. I am with jk technologies jkt9000.com

Kevin
 
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