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.

00:00 - 00:07
I would say that what you get is a system that does what it needs to do and nothing more.

00:07 - 00:38
Right? We basically got the system out of the box that we configured to the processes that we needed. There was no extra overhead. It was exactly what we needed and there was nothing else because we made the processes that we're following. Right? You literally cannot get more streamlined than that. Any other system that we'd be using is putting us into this box that our company doesn't fit into and the ability to make your own QMS, I think, is useful.

00:38 - 00:44
The biggest thing about any quality system right, is that they tend to grow and proceduralize. I think that,

00:44 - 01:08
you want to minimize the number of gates or roadblocks that are between, you know, my goal as the engineer to make some improvement or some design update or resolve some issue that we've identified and acting on that change. Right. How do you have as few roadblocks as possible while still capturing all the information that you need to get regulatory perspective and make sure that you're following a correct process?

01:08 - 01:27
I think that fundamentally the thing that Unifize does very well about that is that the processes are so customizable that if I find something I don't like, I can go talk to the quality engineer and say, Hey, we need to change this. This is this is wasting people's time. And usually we can sit down and agree on that.

01:27 - 01:39
Or maybe there's something I didn't realize. But you know, any individual process has to stand on its own merits or we can cut it right. There's nothing that locks us into anything with Unifize, which I think is really nice.

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

Starting the transformational journey with Unifize
Detailing the transformational journey with Unifize, Jesse Kolstad emphasizes how the platform catalyzes a culture of continuous improvement. Unifize's adaptability and extensive capabilities underline its role as a game-changer in quality management at Biovation Labs.
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.
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.
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.
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.
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.
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.
A paradigm shift in managing quality collaboratively with Unifize
Wilson discusses the significant shift towards collaborative quality management introduced by Unifize. It emphasizes the enhanced cooperation between departments, leading to a more integrated and effective approach to quality control. The speaker credits Unifize for fostering a culture of shared responsibility and streamlined communication, which has been instrumental in improving their product's quality and compliance.
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.
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.
Improving accountability
In this video, Dave Anderson emphasizes the unique approach Unifize brings to improving accountability within teams. By fostering direct, personal interactions over generic software notifications, Unifize encourages a culture where problems are not just flagged but solved collaboratively. Dave highlights how the platform's emphasis on smaller, focused groups and one-on-one conversations enables a more intimate and effective problem-solving process. This method contrasts sharply with traditional email chains, offering a real-time, engaged approach that ensures everyone is directly accountable and involved in the resolution process.
How we manage change on Unifize
Michael offers a behind-the-scenes look into the engineering practices at Harmonic Bionics. He talks about his reliance on tools like SolidWorks for computer modeling and Apache subversion for version control. Despite a limited software stack, there's a hands-on approach to their work, encompassing tasks from debugging robots to prototype development. Michael underscores the systematic approach they follow in documenting design outputs, hinting at the role of Unifize in this process.
Catching rejections by objectively looking at data and taking better decisions
In this video, Seth Bozman discusses Efco's transition from an outdated, cumbersome database system to Unifize for managing their scrap and rework data. He emphasizes how Unifize has enabled a more effective analysis of rejection reasons, offering insights into process improvements. Seth appreciates the platform's role in streamlining data management, making historical data more accessible and actionable for making informed decisions to enhance quality and efficiency.
Under 24h response times from Unifize Customer Support
Dave Anderson praises the exceptional customer support of Unifize in this video, emphasizing the prompt and efficient response times to queries and issues. He shares his positive experiences, highlighting how Unifize’s support team consistently delivers solutions within hours, not days, ensuring minimal disruption to workflow. Dave's testimonial underlines the crucial role of Unifize’s customer service in enhancing operational efficiency and problem resolution, making it a valuable asset to any organization seeking to improve its process management.
Problems with managing quality using Excel and Word
The video outlines the inefficiencies and limitations encountered when managing quality systems through traditional tools like Excel and Word. The speaker describes the struggle with document control, lack of true automation, and the inability to effectively implement reminders or systematize processes for quality management. This approach proved unwieldy, manual-intensive, and required significant personnel oversight, posing challenges for a small company with limited quality assurance resources. The transition to Unifize is depicted as a crucial move to alleviate these burdens and enhance the quality management process.
Streamlining Change Control on Unifize
In this video, Clarissa shares her experience with Unifize, emphasizing its impact on change control and document management in quality management systems. She highlights the challenges of maintaining up-to-date engineering drawings and documentation, particularly in a traditional pen-and-paper environment. Clarissa illustrates how Unifize streamlines these processes, ensuring engineers access the latest revisions, understand changes, and comply with FDA requirements. She praises Unifize's integrated checklist feature and approval process, which simplifies change orders and prevents delays, even when key personnel are unavailable. Clarissa's testimonial underscores Unifize's efficiency, detailing how it transformed their change control process from a lengthy endeavor to a more manageable and efficient system.
How Biovation uses Unifize to create traceability and take better decisions
In this video, Jesse Kolstad of Biovation Labs highlights how Unifize is instrumental in managing ingredient specifications, formulating products, and monitoring trends. He underscores the platform's ability to seamlessly interconnect various stages of the production process, from ingredients to finished products, allowing for enhanced traceability and informed decision-making.
How important is having a single system for everyone to collaborate on all things quality
In this video, Erica expresses her enthusiasm for the collaborative aspect of Unifize, emphasizing its effectiveness in facilitating smooth teamwork without overlapping efforts. She appreciates the platform's ability to connect various departments, including their contract manufacturer, which she frequently mentions in relation to finished good lots. Erica highlights how Unifize streamlines communication, particularly with the contract manufacturer, offering a quicker and more efficient alternative to email or other methods. She notes that other departments also find value in Unifize for accessing files and information. Erica acknowledges some challenges in getting everyone to adapt to a new system but is optimistic about the ongoing efforts of the quality team to improve collaboration across teams. She believes that embracing Unifize will greatly enhance overall efficiency and productivity within the company. This video showcases Unifize's role in promoting effective inter-departmental collaboration and communication.
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.
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.

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
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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.

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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.

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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.