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.
Transcript

[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

10x
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs
Transcript

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

01:19
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.
01:12
How conversations in Unifize foster better collaboration
Tedd Carr is enthusiastic about how Unifize's conversation-driven platform has revolutionized collaboration at The Will-Burt Company. He observed a significant uptake in engagement following a refresher course, likening the buzz of activity to a lively slot machine. This surge in conversations among varied personnel didn't lead to confusion but rather an organized flow of information. Carr takes pride in witnessing the team's proactive interactions and the smooth progression of tasks, indicating a thriving, collaborative environment.
02:23
Get to market faster by enabling agility and overcoming fear
Denis Machoka emphasizes the importance of overcoming the inherent fear of new technologies in the quest for compliance. He advocates for education to bridge the gap between rapid societal advancements and slower professional tech adaptations, stressing the need for agility in today's fast-paced world.
01:48
How a configurable QMS helps engineers
Highlighting the practical challenges engineers face, Michael Hogan emphasizes the value of a tailored QMS. With Unifize, they had a system that catered precisely to their needs, without unnecessary overhead or constraints. The flexibility to mold the QMS to their unique processes proved invaluable, contrasting starkly with other restrictive systems they'd encountered.
01:11
Handling resolutions for repeating issues
Dave Anderson discusses Unifize's resolution process, a critical component tied to the discussion board and quality action ticket system. This process addresses repetitive issues by allowing team members to refer to past resolutions, enabling off-shifts to act without waiting for engineer approvals. By documenting how problems were previously resolved, Unifize empowers supervisors with decision-making support and reduces the need for certain positions, such as the quality auditor on second shift. This growing library of resolutions enhances efficiency and problem-solving capabilities across shifts.
01:41
How Unifize speeds up change control
Jesse Kolstad emphasizes Unifize's prowess in managing change, navigating the challenges of either over-documentation or under-documentation in some companies. With features like versioning, Unifize ensures comprehensive tracking, offering unparalleled visibility and accountability in change management at Biovation Labs.
01:01
Collaborating right from the shop floor using Unifize
Dave Anderson showcases the power of Unifize's mobile application, revolutionizing real-time collaboration directly from the shop floor. He highlights how team members can instantly join discussions, contribute insights, and make decisions without being tethered to a desktop computer. The introduction of barcodes on paperwork, a minimal but crucial use of paper, allows anyone to scan and immediately access the relevant discussion on Unifize. This feature underscores the platform's commitment to enhancing efficiency and communication across various departments, making it a game-changer for operational workflows.
00:34
How big is Applechem
Applechem's current size and plans for expansion are discussed, indicating the company's growth trajectory. With 18 employees and a facility of 18,000 square feet set to expand to 42,000 square feet, the video highlights Applechem's increasing capacity for R&D, manufacturing, and warehousing in response to business growth.
01:25
Wear a seatbelt using Unifize to avoid accidents and save money
Drawing a parallel with wearing a seatbelt, Jesse Kolstad elucidates how Unifize serves as a preventive tool, averting operational mishaps at Biovation Labs. Ensuring safety and compliance, Unifize's proactive features lead to significant cost savings by forestalling potential issues.
00:30
Speeding up finished good lot process from half a day to 10 minutes
Mikala shares her remarkable experience with Unifize, focusing on its impact in optimizing the finished goods lot process. She illustrates how the process duration dramatically decreased from half a day to a mere 10 minutes, showcasing Unifize's efficiency. She also highlights the reduction in the need for quality personnel by 2 to 4 employees, stressing the software's significant role in streamlining operations, reducing manpower requirements, and enhancing overall productivity.
03:06
Raw material validation with Unifize
The video delves into how Unifize streamlines the raw material validation process, enhancing efficiency and ensuring compliance. It highlights the platform's role in simplifying complex validation procedures, thereby facilitating a more robust quality control framework.
01:51
Handling scrap and rework using Unifize
Seth Bozman reflects on the traditional negative perception of scrap and rework and how Unifize has helped Efco to approach these issues as opportunities for improvement. He appreciates Unifize's ability to provide detailed tracking and analysis, enabling Efco to identify root causes and implement effective solutions. This video illustrates how Unifize has empowered Efco to transform challenges into actionable insights, fostering a culture of continuous improvement.
03:00
Connecting the dots- managing a DMR & DHF on Unifize
Denis Machoka emphasizes Unifize's prowess in managing DHF and DMR data, highlighting the platform's traceability, accessibility, and real-time status updates. He appreciates its ability to keep users informed about the latest file versions, preventing potential confusions. Denis also touches upon his AI background and experience with IBM.
02:14
Time saved in streamlining communicaton
In this video, Seth Bozman delves into the significant time savings and efficiency gains Efco experienced by transitioning to Unifize. He vividly illustrates the cumbersome nature of their previous system for handling quality control documents and how Unifize simplified these processes. Seth’s narrative underscores the direct impact on productivity, from reducing the time it takes to write and manage remake cards to enhancing collaboration across departments. This transformation allowed Efco to not only save time but also improve accuracy and accountability in their operations.
02:38
Why Unifize makes post-market compliance a breeze
In this insightful video, Clarissa tackles the complexities of post-market compliance in risk management, focusing on the medical device sector. She emphasizes Unifize's pivotal role in effortlessly connecting customer complaints to corresponding solutions and risk assessments. Clarissa explains how this integration drastically cuts down the laborious task of complaint analysis, enabling proactive and efficient risk control updates, a feature she finds particularly advantageous.
04:05
How Biovation manages Supplier Quality on Unifize
Jesse Kolstad delves into the challenges of juggling multiple suppliers at Biovation Labs. He candidly shares the complications of dealing with myriad versions of similar products, like green tea extracts. With Unifize, Jesse found a way to seamlessly consolidate suppliers, bringing clarity to ingredient and inventory management, and ensuring quality standards are met consistently.
01:44
How has the definition of collaboration changed before and after Unifize
In this video, Wilson explores how the definition of collaboration has evolved within their organization after implementing Unifize. Previously marked by siloed efforts and miscommunications, the adoption of Unifize has led to a more unified and efficient workflow, significantly improving project outcomes and stakeholder engagement.
02:42
Why you can't use Slack and Teams to build life science products
In this video, quality leaders from a popular nutraceutical manufacturer, Adaptive Health share their experience on using communication tools like Slack and Microsoft Teams to manage quality. They emphasise on the fact that these tools disconnect the collaboration from the data, leading to greater redundancies affecting their product launch process. They also share their experience on using Unifize to manage their quality processes end-to-end, and how it improved their collaboration and data management tremendously not just within their organisation, but across their partner organisations as well. Watch this video to know more about why Slack and Teams cannot replace a powerful collaborative eQMS solution like Unifize.
05:04
Problems with managing quality at nutraceutical companies
Jesse Kolstad paints a vivid picture of the recurring challenges he's faced in the realm of quality management. From overloaded file cabinets to underutilized QMS systems, he's seen a pattern of data not being harnessed effectively. Jesse shares his thoughtful approach to quality enhancement, highlighting the importance of keen observation and understanding before diving into reforms, reflecting his depth of experience and commitment to excellence.
00:46
Adopting a new system in an institutional knowledge based shop floor
Dave Anderson shares insights on the challenges and successes of implementing Unifize in a shop floor rich with institutional knowledge. He discusses the initial resistance to change and the skepticism towards adopting new systems. However, Dave highlights the transformative moment when team members begin to use Unifize, noting the ease and efficiency it brings to processes previously burdened by paperwork. This video illustrates the journey from hesitation to acceptance, showcasing the significant improvements in workflow and productivity with the adoption of digital solutions.

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
Video icon

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.

Video icon

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.

Video icon

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.