Calling CAPA Investigators / Deviation Responsibles to kick some tires.

I’ve been dealing with CAPA/deviation issues for medical devices and SaMD and wanted to take the madness out of it. For example, you start reading the notification, and you’re already pretty sure of the reason for the problem even before you’ve investigated.

I don't know about you, but often the issue happens to come back as “human error”, but it’s typically something much bigger with the system itself, as guess what...the issue happens again and again.

I’ve created a tool to help organize investigations in a slightly different way. Much more secure than typing into ChatGPT and more comprehensive with the results. I would never label it as "the investigation" because it certainly is not...as final review stays with the investigator and QA. But it's there to really challenge how you’re thinking about things.

I could go on but I am here to get honest feedback. "This tool is stupid" "takes too long to get a result" "I could use this" "I'm cynical, so here is some hate"...as long as it's honest :)

So if you are comfortable add a real CAPA, if not make one up. I’d really like to get your opinion on it, whether it’s positive or negative.

I am uncertain of Reddit's rules, though I have been a member for a few years, but rarely post, so I am afraid of even posting the name of the app.

If you want to try it end to end, send me a message. I have a limited number of tokens for complete access, and there are no strings attached. No sign up, no email address. nothing expected from you. I just want to understand its strengths and weaknesses from those that with CAPA experience. Thanks!