Why Biovation moved from MasterControl to Unifize
Jesse Kolstad reminisces about his journey with quality management systems, notably his pivotal role in deploying MasterControl. As he navigates through the landscape of electronic documentation circa 2016, he highlights the challenges presented by platforms like SharePoint. While acknowledging MasterControl's early advantages, Jesse candidly critiques its user interface, shedding light on why a transition to Unifize became essential for Biovation Labs.

[00:00 - 00:19]
So my experience with quality management systems when I was at Nelson was launching MasterControl across the organization and that was consolidating three sites by the time I was done. But going through all the at that point it was more about having electronic documentation and this was 2016. So SharePoint wasn't great.

[00:20 - 00:50]
People didn't weren't apt to use it to MasterControl, kind of spoon fed a system that was nice back then, in my early days. But what I came to find was that it's the UI wasn't great and it's a little clunky and arduous for the average user. And what I learned probably most notably was that if it's not designed to be easy for the user, then it's just another hurdle and people, it's a database system, right?

[00:50 - 00:59]
So if you're not getting good data from the users out on the floor and they're not apt to use it, it doesn't serve the purpose other than saying I have a digital system.

[00:59 - 01:24]
What I was looking for when I started down the path with MasterControl was trying to well, go digital first and foremost because paper and file cabinets and banker boxes and those kind of audit preparedness things that I think anybody who's ever been in quality has dealt with is incredibly arduous. So I needed something that just with a few button clicks, I could pull majority of what I needed.

[01:24 - 01:46]
And at the time, again, MasterControl offered a structure which I hadn't obviously launched a QMS at that point, and they gave, as I said, they kind of spoon fed: Here's our hierarchical structure. You want docs, you want training, you want all these things and that was nice. But again, after the fact, I looked back and realized how clunky it ended up being.

[01:46 - 01:55]
And even now I reached back out to some of the people I knew at Nelson. And they still use it, but they they're not fans

[01:55 - 02:21]
I didn't know it at the time, but what I was looking for was a blank canvas, almost like, could I build to suit as opposed to taking something that was hand like designing my process around the system because it's the system wasn't the best option I know now. And having being able to build a system and a process and digital documentation along the way to what I do is so much more valuable.

[02:21 - 02:25]
So our internal customers were using MasterControl.

[02:25 - 02:59]
And honestly, at the time it was kind of a glorified SharePoint. They just would store C of As that the quality team here was generating through word and then email. Every time they'd do a Finished Good Lot release, they would email it to the representative for our internal customers and then they would send this email back that said ‘Approved’, and that was the release process and they would then store that document from the email in MasterControl, frankly, for the sake of storing it in MasterControl.

[02:59 - 03:29]
I mean, email is good ish, but the problem with doing Lot release via email is somebody needs to be at their computer and somebody on both ends has to realize they got it. And then I mean they would hold up. Release of billable, shippable product just because somebody wasn't at their computer and sometimes if it got they're here late in the day and we had a time zone difference also between our internal customer who was over in North Carolina.

[03:29 - 03:38]
And so if we sent it at three, it's five o’clock there, it's a Friday, they may not release it. And now you're withheld shipping till the next week

[03:38 - 03:48]
I mean, as we transitioned to Unifize, a lot of the organization was on MasterControl and there was a lot of apprehension actually to are we going to lose that data?

[03:48 - 04:12]
Where are we going to have to work out of two systems? Is this is this kind of arduous hybrid system for a minute? And Unifize was an absolute helping and and partner in that transition to engage people so they could focus on Unifize and know that all of the stuff we had was safe and accessible. And that transition kind of just happened without skipping a beat.

[04:12 - 04:35]
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.

[04:35 - 04:55]
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.

[04:55 - 05:11]
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

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