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Clarissa Archer highlights adaptability as key in Harmonic Bionics' QMS selection. Unifize allowed them to tailor the software to their needs, avoiding the rigidity of traditional systems. The ability to make direct adjustments without external help was transformative, dramatically accelerating their processes.
Transcript

[00:00 - 00:20]
And what I really enjoyed about Unifize is the fact that we could configure the program to be what we needed it to be rather than trying to work against a program to make it fit into what, for example, we'd want a Design History File to look like we were able to configure Unifize to design it, how we needed it and how we wanted it.



[00:20 - 00:26]
As a part of the configuration of a new process, one of the great things is that I'm able to build these things myself.



[00:26 - 00:34]
I don't need to submit a work order or submit an IT ticket and have the Unifize team build it for me, you know, between two and four weeks.



[00:34 - 00:56]
You know, it's something that I can go into and it's really easy to have the buttons and ability to say, okay, for example, I have a change order. What else does that require? Okay, I need text boxes to explain, what? Each thing needs to go in there. And so I can easily, you know, from a grouping of options, drag and drop, I'm biomedical engineering.



[00:56 - 01:14]
I didn't take a whole lot of software. So much more on the mechanical side of that. So for me, it was so easy to say, Oh, yes, I need to. TextBox, let me drag it over here. Let me arrange it how I need to and write in descriptions and what I need, you know, And another important thing is getting approvals.



[01:14 - 01:34]
You know, you can describe a change order all you want, but you need to make sure that you're getting the proper approvals. So being able to go with advanced approvals and say, okay, here are the options of people that I need to have approve and being able to say, you know, I don't care necessarily who it is, you know, sometimes you might have a problem where, you know, oh, somebody is on vacation.



[01:35 - 01:55]
And in typical other programs, I would see, you know, that person was requested as a signature they either need to, log in on vacation, which nobody wants to do, or completely cancel that change order and go back to the preliminary, which, again, huge waste of time. You know, that can add several days on to a simple change order.



[01:55 - 02:02]
But with Unifize, I can say, okay, I need this to be from a group of product development, create a group with all those users in it.



[02:02 - 02:17]
In that program say, okay, I need somebody from product development to sign here. So I worked with, but I can also have these other people who can look at the conversations and look at everything and Unifize and understand what's going on to sign if I need to as well.



[02:17 - 02:23]
And so it's so simple to be able to drag and drop as many times as you need

How Unifize's no-code configuration speeds up implementation

Unifize Results

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Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
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Faster time-to-market
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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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