A presenter shows how to use an AI tool to generate Quality Management System documents in seconds. A quality manual for a fictional medical device company, complete with ISO 13485 citations, took 30 seconds. Risk analyses and IOVV charts came just as fast, though you still need to manually copy outputs into Word.
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if the better you coach it, the better the output is. So, Eric, to give you a couple examples of how I've, I've worked with it so far is I wanted to see if I could create the skeleton of a fresh quality management system. And so what I did is I went in and I said, you're gonna help me write a quality, quality management system, and we're gonna do it from the ground up. We're gonna reference ISO 13485 and 21 CFR Part 820. I want to start with a template for a quality manual. So using those references, write me a generic quality manual for company named A. And it took 30 seconds, and here was this very rough template with references and sections and headings and everything. And then you have a, an option at the bottom to simply say copy, and you can throw that into a Word document. Now, I've tried to— so I was able to do that for I don't know. I did it for a risk analysis. I did it for an IOVV chart, and it was like output after output. What I haven't found a good mechanism for it to do yet is for me to add in there, create a Word document out of this, and then have it spit that out. But ultimately, when it comes to doing something where you probably could do it on your own, but you'd need to poke around the internet for an hour, odds are you can prompt and, and coach AI to give you exactly that same output in 5 minutes.