Natalie explains the inadequacy of using traditional methods like Excel or pen and paper for managing quality in an FDA-regulated company. She highlights the limitations of these methods in ensuring compliance, tracking changes, and maintaining data integrity. Natalie emphasizes the need for a more robust and specialized system like Unifize, which can handle the complexities and requirements of FDA regulations more effectively.

Transcript

00:00 - 00:19
If you have five products and that's all that your company is making potentially is manageable with an Excel spreadsheet, as soon as you start scaling up or you're making changes to those five products, let's just say you have 20 products, 30, 40, 50, 60, and you're trying to manage everything.

00:19 - 00:23
You know, when I first started here, we had this amount of products.

00:23 - 00:27
Was it manageable to do it the way we were without any system? Yes.

00:27 - 00:44
But as soon as you start finding out that documentation has changed and then you're trying to where are you saving that in the folder? How does everybody know that it's changed? No alerts are going out unless you're sending an email and no one wants a million emails.

00:44 - 00:52
I mean, like we've grown so much, it would be impossible to do everything on paper without a quality management system.

00:52 - 01:11
If we didn't have Unifize it would create a disaster. We would be back to square one with finding different ingredients, reviewing the documentation, figuring out how ingredients are different or similar to each other, We would have to obtain all of that information, again.

01:11 - 01:20
I can't imagine. I think it would be catastrophic. We would have to start from zero with so many different things.

Why can't one use Excel or Pen & Paper to manage quality at a FDA regulated company

02:38

Why Unifize makes post-market compliance a breeze

02:54

Corrective actions and risk assessment with Unifize

01:19

My role and prior MedTech QMS experience

02:27

How Unifize ensures everyone is trained on the right version of documents and SOPs

Approval Workflows

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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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