Comparing Unifize to other eQMS software
Clarissa Archer narrates Harmonic Bionics' journey in searching for an optimal QMS. Evaluating various systems, they prioritized features like change control, product lifecycle management, and electronic signature compliance. While they considered prominent systems like Master Control, ETQ, and Greenlight Guru, their quest for seamless collaboration was paramount.

[00:00 - 00:21]
So in looking for a new QMS, you know, we looked at several options, one of which was paper based still, using SharePoint, using paper and revamping that whole system when we just decided pretty immediately that that wasn't going to work, especially with such a small company wanting to be able to collaborate better.

[00:22 - 00:51]
You know, we looked at several other systems and primarily we looked at what modules were available. So for example, were they able to handle change control? Were they able to handle product lifecycle management? Were they able to handle, you know, for example, 21 CFR part 11 So electronic signatures, that cut out a few options that we had originally looked at because we needed something that was compliant to electronic signatures, that sort of thing.

[00:51 - 01:05]
So we looked at different companies such as Master Control, ETQ, Greenlight Guru, and they all kind of had the same sort of package that we were looking for, but there was something quite missing from them.

[01:06 - 01:31]
So, for example, you know, we also wanted to look at ease of use, the user interface that was really important to myself, being able to organize like a DHF within a program, you know, from my prior company. I had previously used Agile you know, with a lot of different systems that aren't really configurable, you have to kind of work against the machine to create what you need.

[01:31 - 01:52]
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.

[01:52 - 02:17]
Being able to communicate with others via the program via Unifize was really useful because, you know, in other programs and other companies, there's a lot of emails, watercooler chats, messages, and there's a lot of stuff that can kind of get lost or, Oh, hey, I wanted you to add this, that and the other, or you know, sending feedback.

[02:17 - 02:51]
And then when it comes, you know, two weeks later when that feedback is done and I'm re reviewing a document and I'm trying to go okay what did I tell them to do in the first place. You know, I'm constantly working on several different projects at a time and so being able to go into Unifize and see that and see the conversation and say, Oh yeah, I wanted them to add this detail here or change this up, that is so useful in order to be able to not only keep track of everything that's going on per item, but to make sure that we're all on same page.

[02:51 - 03:12]
You know, if somebody is working on a report or a document or a print and, you know, that project gets passed on to somebody else, it's really easy to fall through the cracks. And, you know, oh, this person may have left the company and didn't send out all their notes. You know, that happens all the time. And all kinds of companies, all sizes of company.

[03:12 - 03:28]
And so to be able to have Unifize and see the history and say, oh, wait, this person added in the notes that they needed to add this item into the print, or this was a really critical part in the assembly, and they didn't have time to do it before either they left or moved to a different project within the company.

[03:28 - 03:36]
That's really useful to be able to see, you know, that whole history. And I think that is one of the biggest advantages of Unifize.

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.

Related Case Study Videos

My role and prior MedTech QMS experience
Clarissa Archer, a Quality Assurance Engineer at Harmonic Bionics, shares her decade-long journey in the medical device industry. Beginning in product development, she transitioned to quality assurance, drawn by her passion for risk analysis and compliance. With a biomedical engineering background from Texas A&M, she emphasizes the importance of hands-on experience in understanding regulations in the medical device space.
How we manage change on Unifize
Michael offers a behind-the-scenes look into the engineering practices at Harmonic Bionics. He talks about his reliance on tools like SolidWorks for computer modeling and Apache subversion for version control. Despite a limited software stack, there's a hands-on approach to their work, encompassing tasks from debugging robots to prototype development. Michael underscores the systematic approach they follow in documenting design outputs, hinting at the role of Unifize in this process.
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Get to market faster by enabling agility and overcoming fear
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Clarissa enthusiastically discusses the advantages of Unifize Dashboards in improving visibility and workflow management. She describes how custom dashboards can alert specific teams about pending tasks, like change orders awaiting implementation. Clarissa appreciates the dashboards' ability to prioritize tasks and centralize information, highlighting their role in streamlining operations and fostering team collaboration.
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Taking faster decisions on Non-Conformances with Unifize
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About Tedd and The Will-Burt Company
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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

Here’s how Biovation Labs reduced testing costs from $146K to $65K in two months

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

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