How Unifize helped build our processes efficiently from scratch
In this video, Jesse Kolstad of Biovation Labs contrasts his experience with MasterControl's structured modules to the flexibility offered by Unifize. Reflecting on the early stages of his career, Jesse appreciated the structured guidance, but as his expertise grew, he found immense value in the "blank canvas" approach of Unifize, allowing for tailored and efficient process development.

[00:00 - 00:15]
When I was using MasterControl, that was another thing they did of, well, you can buy the document module, you can buy the training module and, and you have these, these things that structure that the system had built that you could buy because it kind of sort of probably solved a bit of your problem.

[00:15 - 00:25]
And the ones that had this structure for you I can see the value of that going back to early in my career, I didn't know what I was doing.

[00:25 - 00:45]
And so being spoon fed, here's the structure was better than the chaos I was trying to organize. But knowing what I know now, having a blank canvas is and building to suit, building to you, building to your process, not this sort of standard structure that is for all intents and purposes, outlined by the regulations.

[00:45 - 01:07]
So they're ticking boxes for most people and that's why they all do it. But I would, as I've said, much rather build my process around my process instead of fitting a square peg into a round hole that frankly, most systems, even the cloud and SaaS services, will do.

[01:07 - 01:31]
Back when I was shopping around, Unifize, well, the team reached out to me and frankly it was a sort of cold call, but they gave me the Dime tour. And I saw immediately the beauty of being able to paint on a blank canvas, which is what I had always been looking for.

[01:31 - 01:51]
And I could tell I saw immediately that I could, if I needed a process, I could build it. I could say, All right, I need an Out of Spec. Well, what does Out of Spec get you Out of Spec takes you to what are my specs and specs for ingredients predominantly is where I start. And then from there, who are my suppliers of my ingredients and that branches into where am I testing it?

[01:51 - 02:17]
And I saw that right at the get go that these things that have been ruminating in my head since I first was introduced to QMS and how I, I thought I could make it better or build it better for the systems I want to put in place. It afforded me that advantage and that's why I ended up going the route of Unifize is because I could build it and it builds with me as I learn more.

[02:17 - 02:44]
So probably the most unique aspect of Unifize that really got me attracted to it right away was drag and drop built to suit and how short the learning curve was if and it's really helped me implement effectively because implementation is very hard with new softwares, with new systems, especially where there's, you know, probably some old established areas and change is hard.

[02:44 - 03:02]
But what Unifize allows me to do is if I see a broken process or a problem, I could say, Hey, maybe this just needs a checklist and I engage the people who are in it and say, Would this be better? And then I show them how to build it and next thing I know it can. Each conversation type not only engages the users, so you're getting better feedback, better usage.

[03:02 - 03:28]
They're helping you build. So now you have absolute buy in for these people who are across the board, whether they're involved in warehousing or production or maintenance or coding or sales or it's all I find a problem and we customize the checklist at that time with the people and they're part of that. And when you get that, I mean, you can't buy that level of buy in and it gains its own momentum and growth and becomes self-sustaining.

[03:28 - 03:35]
It doesn't need me as the director of quality to constantly oversee it and birddog it. It gets a life of its own. And that's what you want.

[03:35 - 03:41]
People who are evaluating QMSes think outside the box because Unifize will let you.

[03:41 - 04:16]
You don't don't get a quality management system to manage quality, get it to improve your organization every day. And nobody else can give you that. The way this has it's it's not there to just be there. I mean, a lot of times that I've been at many companies where they'll have one system that they're managing their suppliers and their specs in another, that they're, they're managing their artwork approvals and review and another that they're managing their training and they're paying a very substantial amount for each individual system, whereas Unifize puts it all together at once and then connects them end to end.

[04:16 - 04:30]
I don't have to even open another screen or another app or another program I can get everywhere in my process. Everything about this bottle, every everything that went into it, I could get there at any point in the process.

[04:30 - 04:52]
I think other systems approach the problem as we have the solution. You want it, use it, Unifize’s philosophy said, We acknowledge you have a problem. Let's help you figure it out and build your system to use it. And I think other systems, I see how they got there. I see why they got their and I see why it gained traction.

[04:52 - 05:13]
But I think I don't think I'm misspeaking when I say most people, when they look backwards and say, Gosh, I wish I would have built it the way I wanted as opposed to down the line going, Well, now I'm kind of not committed to this whole system that's got everything I know I need, but it doesn't work the way I need it to.

[05:13 - 05:29]
And that's kind of been truthfully, that's kind of been my career progression from when I moved up at Nelson to rolling out MasterControl to where I am now. I look backwards and say, I. I know that that's what I would have wanted if I could go back.

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

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

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