How to make facing FDA audits easy
Clarissa Archer talks about the daunting experience of preparing for audits, especially from rigorous bodies like the FDA. She stresses the importance of a robust documentation system, serving as a "source of truth" during these audits. With Unifize, they could effortlessly produce, present, and recall documentation, simplifying the audit process and instilling confidence in their decisions and actions.
Transcript

[00:00 - 00:15]
So yeah, when you have the big scary FDA people or whoever coming out, you know, you have everything that you need and the whole source of truth right there in writing, you know, you're able to say, “Here's why we made those choices and here's what those choices were”.



[00:15 - 00:35]
You have the ability to print it out on a PDF so you can show them, here's the final product. You know, all the sins are hidden, but they're able to be there so that you remember, you know, when you're being asked very specific questions that, two years from now when you're audited, it's really easy to forget why you made one specific choice.



[00:35 - 00:46]
And so being able to have that conversation there and that history is huge because then you, you know, you present them with the nice PDF that Unifize makes for you with the whole audit trail, everything you need.



[00:46 - 00:56]
And then you have like the less formal conversation that you can look back on. And you know, when they say, why did you make these choices? And you kind of look and you're like, Oh yeah, of course I forgot.



[00:56 - 01:23]
About that, you know, there was an error. There was, you know, a trending issue with some non conformance. And here's why we made those choices. And you can come off very professional prepared without having to say, you know, putting on your professional face. Let me let me get back to you. Let me look into that and furiously typing over at the, you know, the people in the back room who are flipping through papers, freaking out. You have it all there.



[01:23 - 01:36]
You know, a lot of these things take years to happen, whereas with Unifize, we were able to get it done with about four weeks in order to start utilizing our change controls and our documentation controls

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Transcript

But what we've known from what I experience was, is we were able to get there with the system. We still there with the system. The system has what is needed to provide us what we're looking for, because every company, admittedly, is trying to get compliant. If we educate people, if we get people the education that they need and to get over the fear factor, I think 90% of those things can be resolved because most people will go to what they're most familiar with.What I worked with from a different company, but they're not willing to sit down and look at what the demographics are saying. People are into social media now. People are moving fast into fast paced world. But technologies are still antiquated. So there's a disconnect here, right? So while we're moving at a fast pace at home with dragging at work, so why can't we continue that speed while we at work?If your supplier has issues and you're not informed on time, you want to have an alternate supplier in place. If your suppliers are not qualified, you may not know that that needs to happen. And so when you have an integrated system that speaks to itself and is giving you all this data, you literally have the pulse of the organization in your hands as an executive at a money bound access.

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