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

03:10
Investigating deviations with Unifize
The video explains Unifize's approach to managing deviations, emphasizing the platform's effectiveness in identifying, analyzing, and resolving discrepancies swiftly. It highlights how Unifize facilitates a comprehensive investigation process, contributing to higher standards of quality and compliance.
03:30
How to take the plunge on an eQMS- build consensus across the company
Denis Machoka shares Harmonic Bionics' collaborative approach to choosing an eQMS. The team collectively identified and categorized desired system attributes, ensuring the chosen system reflected the team's consensus. This method involved engaging with vendors that met their defined criteria.
02:48
What are the quality standards followed at Applechem
This video outlines the stringent quality standards Applechem adheres to in its product development process. Emphasizing compliance with global regulatory requirements and a commitment to safety and efficacy, it showcases the company's dedication to maintaining high-quality benchmarks in the cosmetics industry.
02:27
Establishing Accountability and taking faster decisions with Unifize
Tedd Carr expresses how Unifize transformed The Will-Burt Company's approach to quality management. The previous system, a chaotic mix of emails and ad-hoc methods, lacked clear ownership and accountability, leading to prolonged issue resolution times. With Unifize, they have consolidated five systems into one, establishing defined accountability and enabling rapid task completion—what once took weeks or months now concludes in days, significantly optimizing their operational efficiency.
03:46
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.
00:41
How does collaborative discussions lead to faster decisions
In this testimonial, Seth Bozman explores the dynamic shift in communication within Efco facilitated by Unifize. He points out how the platform encourages active collaboration and discussions, ensuring that issues such as part completion and quality action tickets are addressed promptly. Seth's narrative underscores the value of Unifize in creating a more engaged, responsive, and collaborative workplace, where decisions are made faster and more effectively.
02:22
About Erica and her role at Adaptive Health
In this comprehensive video, Erica Bennerman introduces herself as a Quality Assurance Specialist at Adaptive Health. She outlines her crucial role in ensuring that products meet customer expectations and adhere to stringent quality standards. Erica explains that Adaptive Health specializes in producing nutritional supplements, where her department focuses on scrutinizing product presentation, artwork, and ingredient compliance. She emphasizes the importance of meeting FDA and General Manufacturing Practices (GMP) standards and maintaining essential documentation for potential audits. Erica shares her professional journey, starting as an Executive Assistant and transitioning into quality assurance, highlighting Adaptive Health's supportive environment for growth and exploration. This video effectively presents Erica's commitment to quality and the rigorous processes at Adaptive Health to ensure superior product standards.
01:23
How we use Unifize as an engineering system of record
Michael delves into his daily tasks, emphasizing his continuous engagement with vital processes such as change orders and quality notifications. He reveals that Unifize constitutes a significant chunk of his workflow, attributing this to the platform's central role as the engineering document of record. Whether it's creating presentations for design reviews or other tasks, Unifize stands as the go-to platform for all engineering outputs.
01:26
Making compliance a part of everyday workflow with Unifize
Wilson discusses how Unifize has seamlessly integrated compliance into daily workflows, transforming it from a cumbersome obligation to an effortless aspect of routine operations. This change has led to improved adherence to standards and regulations, with the speaker emphasizing the platform's role in making compliance natural and manageable.
01:53
About Jesse Kolstad
Jesse Kolstad, the Director of Quality, Compliance, and Formulation at Biovation Labs, gives an intimate peek into his role and the company's operations. Located in Salt Lake City and part of the Wellful organization, Biovation Labs plays a pivotal role in manufacturing capsules and tablets. Jesse also highlights their collaboration with prominent industry giants, underscoring Biovation's significance in the dietary supplement sector.
01:35
The simplicity of the Unifize onboarding process
Denis Machoka praises the effortless onboarding process with Unifize. Pre-established access matrices ensured a smooth transition. He lauds the platform's ease of setup, where users quickly received access links on their devices, and emphasizes the consistent user experience across multiple platforms, highlighting its adaptability.
01:17
Managing part revisions on Unifize
Michael sheds light on the intricacies of managing part revisions at Harmonic Bionics using Unifize. He describes their systematic approach, where each part is tagged with a specific revision. This setup allows team members, like purchasers, to seamlessly access and review older versions of parts when needed. Michael values Unifize's capability to store and present all relevant information, from product definitions to design files, ensuring a comprehensive understanding of each part's evolution.
01:47
How did Dave improve efficiency and save $44,000 by not filling a position
Dave Anderson shares how he capitalized on the departure of a second-shift position to integrate Unifize, leading to a $44,000 annual savings for Efco. This strategic decision was facilitated by Unifize's capability to streamline operations and eliminate the need for the position. By not filling the vacancy, Efco leveraged Unifize's platform to enhance accountability and efficiency, showcasing the tangible financial benefits of adopting digital solutions over traditional staffing strategies.
04:59
How Denis builds a quality culture in MedTech companies
Denis Machoka, a Six Sigma black belt, highlights his transformative approach to Medtech companies. He shares insights on assessing an organization's current state and vision, the critical role of communication in building a quality culture, and the essential tools to foster knowledge and improvement.
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.
01:36
Closing the loop- Traceability and lot tracking using Unifize
Denis Machoka elucidates the intricate process of traceability and lot tracking at Harmonic Bionics, especially for their robotic devices. He details the meticulous tracing of parts, their consumption, and potential issues. Denis highlights how Unifize is instrumental in ensuring precise tracking and updating of materials consumed during the device development.
03:22
Managing Product Lifecycle with Unifize
Delving into Harmonic Bionics' evolution, Michael Hogan speaks about the company's transformation from a small team of college students to a structured entity. As they scaled, the pressing need for robust documentation and product management became evident. The journey underscored the significance of an efficient QMS, ensuring streamlined operations and clarity in decision-making.
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.
01:28
How I reduced Mock Recall time down to 18 minutes with Unifize
Jesse Kolstad dives deep into the world of Mock Recalls, often perceived as a compliance necessity and a cumbersome task. Highlighting the typical time constraints faced during certification audits, he recounts past experiences where meeting the set time frames was challenging. With Unifize, Jesse experienced a game-changing shift, significantly enhancing the efficiency and speed of the Mock Recall process.
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.

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.