Recommendations for affordable CAPA system

#1
Hello,

I work in manufacturing company that produces industrial equipment and we have been using a manual process for the initiation and follow-up of internal CAPAs. Since our company is growing, I need to find and implement a CAPA system that can be used to generate CAPAs to personnel with an assigned due date then have it send auto reminders to the recipients in order to push for closure. It would also be good if the system could generate metrics for CAPAs that are in process, closed, etc. Does anyone know of an affordable system that I can pursue?

Thanks
 
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Bev D

Heretical Statistician
Leader
Super Moderator
#2
I’m sure someone will suggest some software to use.
I am going to caution you that automatically assigning dates for closure is a recipe for disaster. It’s OK to have an initial response date but to have a closure date requires human knowledge. Each corrective action will have it’s own timeframes for containment, corrective action implementations and effectiveness validation. Effective systems require human management, oversight, follow up and guidance. No software can do that for you. My suggestion is to simply use EXCEL to track your CAs…

There is a LOT written here regarding CA systems and how to manage them well…and how to fail.
 

Jim Wynne

Leader
Admin
#3
I work in manufacturing company that produces industrial equipment and we have been using a manual process for the initiation and follow-up of internal CAPAs. Since our company is growing, I need to find and implement a CAPA system that can be used to generate CAPAs
Are you also intending to use this system for preventive action? If not, why the "PA"?
 

FRA 2 FDA

Involved In Discussions
#4
I use Teams to help me manage mine and to assign due dates for different stages, which then takes care of reminding people. It's a very manual process still, but using this has helped "automate" it a little. Might be a good intermediate solution until you can find a more comprehensive system.
 

Ronen E

Problem Solver
Moderator
#5
It’s OK to have an initial response date but to have a closure date requires human knowledge.
(Emphasis added)
Sounds to me like a classic ML application. Like a child learning to walk or talk, it will make mistakes initially (number and severity will depend on quality of training / size of historical database) but it will get better and better over time.
I'm not saying it's the sensible path forward, just pointing out that systems doing this kind of things quite well are already being built and used.

PS
For a more traditional approach, there seem to be an abundance of SW tools available for team/tasks management (which seems to be the essence of a CAPA follow-up system), including Open Source and free tools like this one (just an example I found in a Google search, no affiliation here).
 
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