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Yup. The rule of thumb I learned was that at a FDA regulated facility, "anything that touches the product" is regulated just like it's the product. And when the
by analog31 4y ago
Yup. The rule of thumb I learned was that at a FDA regulated facility, "anything that touches the product" is regulated just like it's the product. And when the FDA audits a facility, they focus primarily on software.
- ok_dad 4y agoYep, and for one spreadsheet that prioritized some work, we had to show the FDA that the spreadsheet didn't materially affect the devices we were manufacturing. Basically, this particular one just told us which lots of goods to inspect first, so at worst case it would have just slowed down our line, not affected the device's quality. We still had to take 1 hour to walk some inspectors through our use of it, and why it wouldn't fuck things up. I also started a project to upgrade some software from some old in-house developed stuff to an SAP module (gross, but effective) and it took about 18 months just to make the development and rollout plan, since it was incoming inspection software so it was super important to get right. I left before I saw how long it took to develop, but I think that's the easy part of the whole process.
- runevault 4y agoI don't think I could do FDA software, it sounds so painful. Same with voting machines that are properly regulated (had a CTO at one point who previously did that sort of work and he had stories to tell). Fintech is hard enough.