Getting engineering to adopt a new eQMS
Clarissa Archer reflects on Harmonic Bionics' transition from a research-centric organization to one focused on compliance. She reminisces about the sudden surge in documentation and the challenges it presented to engineers and product developers. Accustomed to flexible laboratory environments, the team had to adapt to the structured, documentation-heavy world of compliance, making the choice of a user-friendly system like Unifize crucial.

[00:00 - 00:18]
So one of the unique challenges in moving from a research focus organization to a compliance based organization is all of a sudden you have this influx of documentation that you know, the engineers and other people in product development aren't quite prepared for.

[00:18 - 00:30]
So, you know, you go from students or people who are typically used to working in very laboratory environments or, you know, people who love engineering and love innovating.

[00:30 - 00:54]
But for them it's, oh wait, this didn't work. Let me, you know, turn this to this kind of do these little things without having documented it, which is a huge issue when you're trying to be a medical device organization with everything needs to be documented. And so, you know, we had that with paper based systems, which was really difficult.

[00:54 - 01:19]
And then to move forward and say, okay, we're going to be using Unifize to actually create a quality management system. I think a lot of the pushback or conflicts we had originally or yeah, we're like pushback. There wasn't really conflict, but the pushback we got was primarily from needing documentation where there were previously we didn't require or it wasn't required.

[01:19 - 01:59]
And so I think one of the great things about Unifize was we were able to push this QMS in a system that was easy to understand, easy to use and so I feel like a lot of the pushback was largely from having to do something they had never done before, Having the Unifize team discuss and show the engineers how to use it, they really adopted it pretty quickly and were able to notice like, Oh wait, previously I had to do a change request and then a change order and all of this. And it would take three weeks to implement, you know, from beginning to end.

[01:59 - 02:24]
Now it can take a couple of days. So I think that really helped with the adoption and the understanding that, yes, we can still move fast, but we need to move fast, in a compliant way. And so making it easier to document changes and to document these things, I think really took out a lot of the pain of having to document it in the first place.

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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