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.
01:03
How to effectively utilize Unifize
In this insightful video, Carol Wilson from Efco discusses the critical success factors for implementing Unifize within an organization. She emphasizes the necessity of company-wide adoption, from top-level management to every department, to fully leverage Unifize's capabilities. Carol shares her firsthand experience with the platform, highlighting how comprehensive engagement ensures seamless collaboration and efficiency. She underscores the importance of management endorsement and following through on processes to realize the full potential of Unifize, reflecting on its impact on audits and data management.
02:07
Centralizing master formula and reducing redundancies with Unifize
In this video, Mikala explains the benefits of using Unifize to centralize the master formula and reduce redundancies. She discusses how the platform has streamlined their formulation processes, improved accuracy, and reduced errors. Mikala highlights how this centralization has led to better resource management and efficiency in their operations, emphasizing the role of Unifize in enhancing productivity and reducing waste.
01:00
Why does Seth consider Unifize's Customer Support, urgent?
In this video, Seth highlights the exceptional customer support provided by Unifize, detailing his interactions with the team and their responsive, solution-oriented approach. He appreciates the platform’s ability to address urgent requests swiftly, enhancing Efco’s operational efficiency. Seth’s experience underscores Unifize’s commitment to customer satisfaction and its impact on streamlining workflows and resolving issues quickly.
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.
01:10
What does Adaptive Health do
Natalie discusses the core activities of Adaptive Health, highlighting their focus on developing and marketing high-quality dietary supplements. She emphasizes the company's commitment to product safety and efficacy, and their adherence to stringent regulatory standards. Natalie also outlines how Adaptive Health differentiates itself in the market through innovative product development and a strong emphasis on quality control, which is significantly supported by using advanced tools like Unifize.
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.
00:30
How to standardize institutional knowledge for enhancing clarity
Seth Bozman shares insights into how Unifize has played a crucial role in capturing and standardizing institutional knowledge at Efco. He highlights the challenge of relying on knowledge passed down through years of experience and how Unifize's structured approach to operational procedures has facilitated better decision-making. This video demonstrates Unifize's impact on preserving critical knowledge and ensuring it's accessible to all, thereby speeding up processes and enhancing efficiency.
02:54
What other eQMS are missing- Separating conversations from data
Denis Machoka pinpoints a critical shortfall in many eQMS: the division of conversations and data. He critiques the inefficiencies of navigating isolated data and scattered emails, championing Unifize's innovative fusion of both. By merging discussions with data, Unifize presents a unified, actionable view, streamlining decision-making and collaboration.
03:16
Using Unifize to track Non-Conformances and Deviations
Clarissa delves into the intricacies of tracking production deviations and non-conformances through Unifize. She sheds light on the platform's adeptness in generating quality notifications, seamlessly linking them to specific parts, suppliers, and relevant processes. Clarissa underscores how this functionality not only aids in pinpointing recurring quality issues but also streamlines the management of corrective actions. Her enthusiasm is evident as she details Unifize's role in enhancing quality tracking and review processes.
00:44
Transitioning from an existing eQMS to Unifize
Highlighting the transition from a traditional eQMS to Unifize, Jesse Kolstad lauds the platform's flexibility and advanced capabilities. With its user-friendly interface and transformative features, Unifize has brought about significant operational improvements at Biovation Labs.
00:56
Accelerating product development by upto 30% with Unifize
In this video, Wilson discusses the transformative impact of adopting Unifize on their product development process. Previously, their development cycle ranged from 18 to 24 months, a duration they attributed to thorough product development and quality assurance. However, since implementing Unifize, Wilson notes a significant acceleration, estimating a 30% increase in speed from ideation to pre-commercialization stages. He anticipates further efficiencies and a potential reduction in cycle time by up to 40% as Unifize becomes more integrated into their systems, highlighting the solution's capacity to enhance productivity and expedite market readiness.
02:28
Evaluating other eQMS software tools
Denis Machoka delves into the evaluation process of various eQMS tools, citing considerations for present needs and future growth. Comparing Unifize to platforms like Ignite EDMS, Veeva, and Greenlight Guru, he underscores Unifize's ease of implementation and its integrated conversation feature as standout advantages.
01:08
Moving away from CCPs to Preventative Controls with Unifize
Highlighting the shift to preventative controls, Jesse Kolstad values Unifize's visibility and supplier management. Unifize seamlessly aligns with food safety, optimizing supplier evaluations and quality control at Biovation Labs.
01:25
Enhancing traceability and improving visibility and accountability with Unifize
This video showcases Unifize's capabilities in boosting traceability, visibility, and accountability within organizational processes. The speaker illustrates how the platform fosters a transparent environment where tasks and responsibilities are clear, enhancing overall operational efficiency.
00:45
Why Mikala uses Unifize for 80% of her work
Mikala shares her reliance on Unifize for a significant portion of her work, detailing how the platform supports 80% of her daily tasks. She discusses the diverse functionalities of Unifize that facilitate efficient management of quality processes, documentation, and compliance. Mikala emphasizes how Unifize enhances her productivity, ensures accuracy, and simplifies complex processes, making it an indispensable tool in her professional routine.
01:08
Moving records from paper to the cloud
In this insightful video, Dave Anderson discusses the pivotal shift from paper-based processes to cloud-based solutions with Unifize. He shares the historical challenges of managing quality control and inventory through cumbersome paper records, detailing how these processes were prone to errors and inefficiency. With Unifize, Dave explains the transition to digital record-keeping, highlighting the platform's ability to foster smaller, focused discussion groups for problem-solving, ensuring all stakeholders are informed and engaged in real-time. This digital transformation has significantly enhanced accuracy, collaboration, and resolution speed within his organization.
02:39
Why Unifize's approach to collaboration is transformational
Describing the communication challenges Harmonic Bionics faced in the past, Clarissa Archer praises Unifize for its centralized approach. Unlike previous tools where information often got lost in the shuffle, Unifize provided a consolidated platform that made tracking and acting on feedback more streamlined, especially during multitasking.
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.
00:49
Document control with Unifize
This video from Wilson illustrates how Unifize transforms document control, making it more organized and accessible. The speaker discusses the benefits of centralized document management, including improved traceability, reduced errors, and enhanced collaboration, which are vital for maintaining quality standards and regulatory compliance.

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.