What are the compliance standards followed at Adaptive Health
In this video, Mikala outlines the compliance standards followed at Adaptive Health. She delves into the various regulatory requirements they adhere to and how maintaining these standards is critical for their operations. Mikala explains how Unifize plays a vital role in ensuring compliance, managing documentation, and streamlining processes to meet these rigorous standards effectively.
Transcript

00:00 - 00:02
So 111 is specific to dietary supplements.



00:02 - 00:16
So the food safety aspect, making sure everything is, that's getting to the end consumer is safe, of course, meaning we follow FTC, too. So a lot of the marketing claims that we make, we have to make sure they're realistic and not misleading to any consumers.



00:16 - 00:20
But I would say the the main takeaway is just the food safety aspect of it.



00:20 - 00:28
21 CFR part 111, 117 and then part 11 with inherently built into all of our quality processes.



00:28 - 00:45
We do a lot of our own raw material sourcing. So making sure that when our manufacturers are testing the raw material that it is meeting ID and ASCI requirements, we review those as well. We don't rely solely on our contract manufacturers to qualify materials and then we obviously qualify are our manufacturers.



00:45 - 00:58
So in addition to Biovation we have ten plus other co-mans that we use. So going on site, auditing their individual processes to make sure everything they're doing is up to code that's been in compliance with Part 111.

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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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