Implementing a collaborative eQMS in 4 weeks
Clarissa Archer recalls the initial days of Harmonic Bionics' adoption of Unifize. While they had experience with systems that took ages to configure, Unifize stood out with its rapid setup. Working closely with the Unifize team, they tailored the system to their unique requirements, finding it far more adaptable than larger systems like Agile.

[00:00 - 00:50]
One of the big benefits of Unifize is that the ease of configuration as well in order to get in a quick startup. So, you know, the company itself and the founders even worked really hard with our team to help us with templating and, you know, going back and forth to be able to configure exactly what we wanted these processes to look like for example, Agile, which is what I'm the most comfortable with, you know, that took huge teams at a very large company, you know, teams of 20 or so at least people testing and creating and configuring where, you know, a small startup company doesn't have that kind of manpower and doesn't have the engineering hours to be able to put in to, you know, implementing a new team's.

[00:50 - 01:06]
But just based off of what I've seen from Unifize and having personally helped configure it, it's much easier and simpler to put together and make exactly what we want and what we need for the quality management system and to get it running.

[01:06 - 01:10]
Throughout implementing the system, we still had to do change control.

[01:10 - 01:39]
And our other we saw to continue the company process, right? So we still had to be working with our paper and pen system, you know, still maintaining their work there to try to get us to launch and starting with Unifize, it took us about four weeks to get us up and running to at least do what we needed in order to move our product and continue our, you know, regular systems going.

[01:39 - 02:03]
It took us about four weeks to do that, you know, and that's on a team of maybe five people, primarily, most of us doing other things as well, you know, comparatively with other companies and not having that same support that Unifize gave us and the different type of software and the complexity that would have taken us a much longer time.

[02:03 - 02:16]
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

Unifize Results

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

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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Experience the benefits of Unifize

4x Faster time-to-market

Map Unifize to your processes and streamline workflows, process automation, and prioritization

70% Fewer meetings

Less meetings with in-app collaboration, real-time updates, and decision logs

10x Speed to compliance

Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices

View More Case Studies

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Learn how and why Biovation Labs, an FDA regulated nutraceutical manufacturer based in Salt Lake City, took the decision to transition from MasterControl to Unifize for their product lifecycle (PLM) and quality management (QMS) processes.

Here’s how Harmonic Bionics slashed time to market by 80%

Clarissa Archer shares her experience integrating Unifize into Harmonic Bionics, underscoring its value in streamlining change control, facilitating communication, and ensuring robust documentation for regulatory compliance in the medical device sector.

Will-Burt's game changing boost to quality process cycle times

Learn how The Will-Burt Company was able to implement and adopt a new quality management system across 8 collaborating teams in less than a day and streamline internal / supplier non-conformances, customer complaints (VOCs), internal / supplier audits, 8D reporting, corrective actions and preventive actions.