Avoiding the mistake of thinking you need a complex QMS software to scale
Denis Machoka addresses misconceptions in QMS, emphasizing the value of easily accessible information for compliance. He challenges the notion that larger, more complex systems are inherently better, suggesting that simplicity and efficiency should be the focus.

00:00 - 00:10
I think I think one of the things that any quality manager, if you're looking at this, the first thing you want to know is it's really two things.

00:10 - 00:30
What type of information is available, where it's located and how I can get it to make decisions. Really, that's the most important part. That information that you're looking for is going to help you become compliant one way or another. You're going to use that information to help you become compliant. So where does it located? How is it accessed?

00:30 - 00:59
How the ease of finding it? So you always looking at balancing, trying to balance where that information is located and how you are going to use it? There's a misconception. I'm trying digressing here for a second. There's a little misconception that you have to have these complex systems in order for you to manage an organization. Right. There's a concept that at the end of the day, you need to have this big document and systems and all of these for organizations.

00:59 - 01:21
But if you look at the facts and the things on the ground and really what you're trying to accomplish is to know your data very well so you can make informed decisions, that's what you're trying to do. How do you get that data? You need to have a system that is easy to get that data, easy to navigate, easy to get what you're looking for.

01:21 - 01:43
So you can be compliant because the ultimate goal of any business is to be compliant. So why would we make that job difficult if our goal is to be compliant, then let's make the easy way of getting compliant the fastest way, the easiest way to get there, the most direct way to get there. And I think Unifize can do that.

01:43 - 01:59
Allows you to have that collaboration without multiple systems, without a lot of IT loggings and a lot of management. It eliminates all of that and takes all that conversation within the system and that was significantly helpful in what we did.

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

How Unifize helped reduce our training time and costs
Jesse Kolstad discusses the transformative role Unifize played in Biovation Labs' training process. By establishing a cohesive link between SOPs, training modules, job roles, and employees, Unifize brought unparalleled structure. Jesse also introduces a novel approach of integrating QR codes on RFID badges, allowing for on-the-spot verification of an employee's training status. This innovative system streamlined compliance checks and significantly cut down on training costs.
How Unifize's real time collaboration empowers faster and efficient decision making
In this video, Jesse Kolstad of Biovation Labs accentuates the power of Unifize's real-time collaborative environment. He praises its capability to manage multiple tasks concurrently, leading to significant time savings, increased visibility, and enhanced communication. Jesse emphasizes how this real-time collaboration facilitates swift and effective decision-making.
Risk Management made easier on Unifize
Clarissa explains the criticality of risk management in the medical device sector, emphasizing patient safety. With Unifize, they've streamlined risk management, integrating their documentation and analysis seamlessly. The platform facilitates creating input-output matrices, linking design choices directly to user needs and demonstrating the impact on safety, thus simplifying compliance and ensuring a clear path to safe, effective medical solutions.
How Unifize helped reduce $60,000 of material cost on just one product
Jesse Kolstad shares a transformative experience at Biovation Labs, emphasizing the power of perspective. With Unifize, he could holistically evaluate their ingredient performance and volumes, enabling him to whittle down from 16 SKUs to just two. This consolidation not only simplified management but also resulted in substantial cost savings for the company.
Using dashboards on Unifize to make Management Review Meetings Easier
Denis Machoka underscores the significance of Unifize's dashboards in streamlining management reviews. Highlighting the need for quick access to high-risk data points, he appreciates the platform's ability to present crucial insights on-demand. Denis contrasts Unifize's efficiency with the traditional, tedious method of manually collating data, emphasizing the time savings.
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.
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.
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.
Reducing the time to resolve customer complaints on Unifize
Jesse Kolstad highlights how Unifize expedites the resolution of customer complaints. Offering tools for rapid issue identification and fostering team collaboration, Unifize streamlines the complaint resolution process, ensuring accountability and efficiency in addressing customer concerns.
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.
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.
About Harmonic Bionics- a robotics MedTech company in Austin, Texas
Harmonic Bionics, based in Austin, Texas, designs robots to assist in upper chest healing for patients with mobility challenges, especially those recovering from strokes. By facilitating limb movements, these robots aid in retraining neural connections. The company is FDA-registered and collaborates with the University of Texas for research.
Doing 95% internal audits remotely with Unifize
The Will-Burt Company's pivot to remote operations, as narrated by Tedd Carr, showcases the agility afforded by Unifize. Amid travel restrictions, they've successfully shifted 95% of internal audits to a remote format, utilizing Unifize to maintain stringent compliance without the need for physical presence in their Tulsa location. This transition underscores Unifize's conversational-driven software's strength in facilitating seamless and efficient audit processes.
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.
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.
Minimising the impact on IT while implementing Unifize
The Will-Burt Company strategically chose Unifize to alleviate their IT department's workload. Tedd Carr appreciates that Unifize's team handled everything from installation to launch, ensuring minimal IT involvement. This approach not only streamlined the implementation process but also allowed their IT staff to focus on other critical internal tasks, marking a significant internal shift towards efficiency and resource optimization.
How Unifize's configurability helped us fight the resistance to change
Tedd Carr highlights the configurable nature of Unifize as a pivotal element in overcoming resistance to change at The Will-Burt Company. He values the software's adaptability, allowing for a familiar feel akin to their previous systems, thus simplifying the transition. The Unifize platform mirrors their old forms but with a new, conversation-driven approach, resulting in a smoother learning curve and quicker adoption among staff, leading to a more relaxed and progressive work environment.
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.
Collaborating with vendors using Unifize
Michael elaborates on Harmonic Bionics' systematic approach to documenting design outputs, emphasizing their reliance on definitive documents such as step files and PDFs. He offers a peek into his daily routine, which frequently involves addressing quality notifications on Unifize, collaborating with vendors, and updating specifications. Through his narrative, the importance of Unifize in streamlining vendor interactions and ensuring accurate design documentation becomes evident.
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.

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

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.

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.

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.