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.

Related Case Study Videos

Comparing Unifize vs QT9
In this detailed comparison, Dave Anderson shares his candid insights on choosing Unifize over QT9 for quality management at Efco. He praises Unifize for its superior collaboration features, emphasizing how it promotes more personal and effective problem-solving through direct conversations and teamwork, unlike QT9's focus on mere record-keeping. Dave highlights the difference in sales delivery and upfront communication about platform capabilities, which made Unifize stand out. This testimonial underscores the importance of collaboration in modern quality management systems and how Unifize excels in creating a more engaged and accountable team environment.
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.
Fostering a culture of continuous improvement with Unifize
Mikala shares her experiences in fostering a culture of continuous improvement at her organization using Unifize. She details how the platform has been instrumental in promoting collaboration, streamlining processes, and encouraging proactive problem-solving. Mikala underscores the importance of Unifize in facilitating a more dynamic and responsive approach to quality management, which has been pivotal in driving continuous improvement and operational excellence.
Enabling effortless information flow across the board with Unifize
Seth Bozman explores the challenges of articulating needs and implementing changes within Efco's operational procedures before Unifize. He reflects on the iterative process of customization and adaptation with Unifize, emphasizing its role in fostering a more efficient, error-proof workflow. Seth's story illustrates Unifize's capacity to streamline communication and process flow, ensuring that operational changes are seamlessly integrated and accurately reflected across the board.
Experience with UniPoint
Mikala provides an in-depth analysis of her journey with UniPoint, discussing its inefficiency and cumbersome operational process. She contrasts these experiences with the seamless, intuitive, and effective functionality of Unifize. This comparison effectively demonstrates Unifize's superiority in user experience, operational efficiency, and its ability to provide a more streamlined and effective approach to quality management processes.
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.
Why Slack and Teams can't replace a collaborative eQMS like Unifize
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.
Managing your Design History File on Unifize
In this video, Clarissa talks about the transformative experience of managing Design History Files (DHF) using Unifize. She contrasts the challenges of traditional DHF management with the streamlined, intuitive approach offered by Unifize. Clarissa details how the platform efficiently links various documents, processes, and reports, facilitating a smoother review process for manufacturing readiness and design transfers, a feature she finds exceptionally beneficial for product development.
Hear about things in real-time and start conversations early on with Unifize's mobile capabilities
Tedd Carr discusses the significant advantage brought by Unifize's mobile functionality to The Will-Burt Company. With a web and cloud-based system, Unifize's mobile app enables their sales force to initiate quality conversations and address customer concerns instantly while on the move. This real-time communication capability has proven to be a valuable tool, fostering timely discussions and swift issue resolution, and is especially praised by those who often work remotely or travel.
How the Unifize team helped build our customisations faster
In this engaging video, Erica offers a fresh perspective on Unifize's standout customer support. She praises the promptness of the team, often responding within an hour, sometimes even in 10 minutes, ensuring immediate assistance. Erica shares her initial experiences as a new user of Unifize, emphasizing the value of regular team meetings in her learning process. She is particularly impressed by the platform's ability to tailor features to specific needs, such as creating custom PDFs, and the team's proactive approach to fulfilling complex requests. Erica's account highlights Unifize's dedication to responsive and personalized support, making the user experience both seamless and adaptable.
Problems I faced with other eQMS that Unifize solved
Michael Hogan candidly shares his past frustrations with traditional QMS platforms. Recounting experiences where designs were sent into a seemingly endless void, only to receive feedback weeks later, he stresses the inefficiencies of such systems. For dynamic startups like Harmonic Bionics, where agility and promptness are paramount, a responsive and interactive QMS like Unifize became indispensable.
How approvals in Unifize helped us collaborate across organizations and get things turned around faster
Mikala discusses how Unifize's approval features have enhanced collaboration across different organizations and expedited turnaround times. She highlights the platform's ability to streamline approvals, improve communication, and facilitate quicker decision-making. Mikala shares specific instances where Unifize's efficient approval processes have led to faster resolutions and better collaboration, underscoring its impact on operational efficiency.
How Unifize improved our Non-conformances closure time by 75% within the first month
Within just a month of deploying Unifize, The Will-Burt Company slashed non-conformances closure times by an impressive 75%, as Tedd Carr attests. Previously languishing non-conformances averaging 4 to 5 weeks for resolution are now dealt with in a mere 7.2 days. This remarkable improvement in efficiency extends to customer complaints as well, with closure times cut by 60%, signaling a swift and responsive quality management system that's set to evolve further.
How Erica uses Unifize on a daily basis at work
In this video, Erica details her daily use of Unifize in managing various quality assurance processes at her workplace. She explains how the platform aids in overseeing finished good releases, tracking sale keys, and maintaining standard operating procedures. Erica highlights the convenience of storing and accessing artwork on Unifize, emphasizing the platform's efficiency in managing document revisions. She notes that while managing revisions was challenging with other systems, Unifize simplifies this process, making it more manageable and less time-consuming. This video showcases Unifize's effectiveness in streamlining complex quality control tasks, underscoring its value in a professional setting.
Why Unifize was such a breath of fresh air in the quality management world
This video highlights Unifize's innovative impact on the quality management sector, praising its user-friendly interface, flexibility, and comprehensive features. The speaker describes how Unifize stands out from traditional QMS solutions by encouraging proactive engagement and simplifying complex processes, making quality management more accessible and effective.
About Harmonic Bionics, an early stage med device company
Clarissa Archer sheds light on Harmonic Bionics, a robotics startup. Their flagship product, Harmony SHR, assists rehabilitation for those with shoulder impairments due to neurological or muscular issues. Initially research-driven, the company now emphasizes quality assurance, aligning with FDA regulations and recommended ISO standards.
How Unifize helps save time and get things done faster
In this video, Michael from Harmonic Bionics celebrates the transparency and coherence Unifize offers. He values the platform's ability to keep everyone synchronized, viewing the same documents and chat histories. This clear and shared understanding of processes, from part designs to quality notifications, not only fosters efficiency but also lets Michael concentrate more on his primary responsibilities, enhancing productivity.
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.
What it really means to Unifize your information and people
Clarissa Archer shares the transformative impact of Unifize on Harmonic Bionics' operations. Beyond just a QMS, Unifize emerged as a tool that seamlessly connected people and information. Whether dealing with complex scenarios like non-conformances or change orders, the platform ensured they always had a holistic view, enhancing clarity and decision-making.
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.

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.