Just curious what medical companies do for FDA compliance regarding Audit Reports? Do you print out reports generated from Tulip, or have an app to display data that is being requested? Do you just let the FDA have access to everything?
I’m hoping to get a conversation going about solutions other companies have put in place. We’re just getting up and running with Tulip, so there’s an opportunity to build something before we go live later this year.
Hey @jasonh, this is a great question. I hope some folks who’ve have gone through this process chime in soon. If not, I can pull one of our regulated industry experts in to provide some color around this.
HI Jason, can you clarify what type of audit reports you are referring to?
In general the platform is considered qualified and you can access the documentation here: https://gxp-docs.tulip.co/. If you are referring to eDHR/eBR type of documentation those are provide by an App that is purpose built to show and browse the history records.
I don’t have anything specific in mind, more in general. The goal was to get a conversation started about what companies are doing for their audits. I was hoping to learn more about structure and procedure, so we could have ideas to work from.
I would agree with giladl that you can create the views you want for eDHR/eBR through app configuration. If you are referring to ad hoc questions during inspection, i would put that in the hands of an experienced Tulip user with the right access that is comfortable with how and where to find data in the system. This is the same for any digital tool. We cannot imagine all the ways that an inspector might want to see information.