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In this video, Clarissa shares how her team slashed implementation timelines from weeks to days using Unifize’s AI—without compromising on compliance. Discover how AI-generated suggestions, human oversight, and smart documentation accelerated their journey to FDA readiness in just four weeks.
Transcript

00:00 - 00:27
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. These are suggestions. And the human at the end of the day is saying, yes, these are correct with what I would say or no or let me tweak it.



00:27 - 00:52
And so I think that's where you can show like, no, you don't just click a button say Suggest AI and then you move on from that process. You look at the suggestions, approve what's being done, and you sign off on it. You know what I mean? Like, I think that's part of what you can show an auditor and say, yes, AI may have generated this, but I verified each of the outputs and confirmed that that is correct.



00:52 - 01:12
And it would take three weeks to implement from beginning to end. Now it can take a couple of days. That really helped with the adoption and the understanding that yes, we can still move fast, but we need to move fast in a compliant way.

How fast can you achieve Medical Device compliance with AI

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Unifize Results

10x
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs
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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