Getting engineering to adopt a new eQMS
Clarissa Archer reflects on Harmonic Bionics' transition from a research-centric organization to one focused on compliance. She reminisces about the sudden surge in documentation and the challenges it presented to engineers and product developers. Accustomed to flexible laboratory environments, the team had to adapt to the structured, documentation-heavy world of compliance, making the choice of a user-friendly system like Unifize crucial.
Transcript

[00:00 - 00:18]
So one of the unique challenges in moving from a research focus organization to a compliance based organization is all of a sudden you have this influx of documentation that you know, the engineers and other people in product development aren't quite prepared for.



[00:18 - 00:30]
So, you know, you go from students or people who are typically used to working in very laboratory environments or, you know, people who love engineering and love innovating.



[00:30 - 00:54]
But for them it's, oh wait, this didn't work. Let me, you know, turn this to this kind of do these little things without having documented it, which is a huge issue when you're trying to be a medical device organization with everything needs to be documented. And so, you know, we had that with paper based systems, which was really difficult.



[00:54 - 01:19]
And then to move forward and say, okay, we're going to be using Unifize to actually create a quality management system. I think a lot of the pushback or conflicts we had originally or yeah, we're like pushback. There wasn't really conflict, but the pushback we got was primarily from needing documentation where there were previously we didn't require or it wasn't required.



[01:19 - 01:59]
And so I think one of the great things about Unifize was we were able to push this QMS in a system that was easy to understand, easy to use and so I feel like a lot of the pushback was largely from having to do something they had never done before, Having the Unifize team discuss and show the engineers how to use it, they really adopted it pretty quickly and were able to notice like, Oh wait, previously I had to do a change request and then a change order and all of this. And it would take three weeks to implement, you know, from beginning to end.



[01:59 - 02:24]
Now it can take a couple of days. So I think that really helped with the adoption and the understanding that, yes, we can still move fast, but we need to move fast, in a compliant way. And so making it easier to document changes and to document these things, I think really took out a lot of the pain of having to document it in the first place.

Related Videos

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

Managing the product lifecycle and ensuring efficient traceability with Unifize
Jesse Kolstad underscores the imperative of traceability in regulated industries. Drawing from his experience at Biovation Labs, he illustrates how Unifize seamlessly interlinks finished products, ingredients, formulae, and even packaging artwork. The platform's collaborative nature fosters real-time discussions, merging processes that were once scattered across emails and calls into a unified and efficient workflow.
Watch Video
Accelerating feedback loops by creating transparency using Unifize
Denis Machoka highlights the transformative power of transparency through Unifize, emphasizing clarity in responsibilities and priorities. He praises its capability to communicate seamlessly with a broad audience and values its mobile integration, enabling real-time updates without the need for multiple tools or email checks.
Watch Video
How Biovation manages Supplier Quality on Unifize
Jesse Kolstad delves into the challenges of juggling multiple suppliers at Biovation Labs. He candidly shares the complications of dealing with myriad versions of similar products, like green tea extracts. With Unifize, Jesse found a way to seamlessly consolidate suppliers, bringing clarity to ingredient and inventory management, and ensuring quality standards are met consistently.
Watch Video
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.
Watch Video
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.
Watch Video
How Unifize's no-code configuration speeds up implementation
Clarissa Archer emphasizes the significance of adaptability in Harmonic Bionics' choice of a QMS. With Unifize, they could shape the software to their specific needs, bypassing the rigidity of traditional systems. The power to make direct adjustments without relying on external teams was a game-changer for them, speeding up processes significantly.
Watch Video
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.
Watch Video
How Unifize ensures everyone is trained on the right version of documents and SOPs
Jesse Kolstad sheds light on the intricacies of document control, a critical component across regulated industries. While debunking common myths, he underscores the importance of more than just maintaining master copies. With Unifize, the emphasis is on ensuring that everyone in the organization is well-trained and aligned with the most recent versions of documents and SOPs, guaranteeing compliance and efficiency.
Watch Video
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.
Watch Video
Reducing lot release time down to minutes with Unifize
Jesse Kolstad highlights how Unifize has dramatically curtailed lot release times at Biovation Labs. By optimizing the process, Unifize ensures lot releases are executed efficiently, reducing times to mere minutes.
Watch Video
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.
Watch Video
Managing Incoming Material and Lot Tracking on Unifize
In this video, Clarissa discusses the challenges and solutions for managing incoming materials and lot tracking using Unifize. They emphasize the difficulties faced in quality assurance, especially when parts or products do not meet inspection standards. The video illustrates how Unifize streamlines this process by enabling easy tracking of lots, keeping essential documents like certificates of conformance and material certificates organized. The speaker highlights the convenience of having all relevant information, such as lot numbers and PO numbers, scanned and stored in Unifize, facilitating efficient tracking and inspection. They conclude by praising Unifize's collaborative features, which significantly enhanced their team's engagement with the new Quality Management System (QMS).
Watch Video
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.
Watch Video
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.
Watch Video
Speed to market in Medtech is about empowering the quality team
Denis Machoka discusses the factors influencing speed to market in Medtech, focusing on the complexities of implementing a quality system. He underscores the detailed understanding of workflows, IT support needs, security considerations, and the potential high costs and maintenance of many systems, emphasizing their impact on the final product's cost.
Watch Video
Implementing a collaborative eQMS in 4 weeks
Clarissa Archer recalls the initial days of Harmonic Bionics' adoption of Unifize. While they had experience with systems that took ages to configure, Unifize stood out with its rapid setup. Working closely with the Unifize team, they tailored the system to their unique requirements, finding it far more adaptable than larger systems like Agile.
Watch Video
How Unifize helps quality leaders take better decisions on Out of Specs
Jesse Kolstad revisits a challenging situation from his early days at Biovation Labs — a significant backlog of Out of Specifications (OOS) cases. Determined to enhance the OOS process, Jesse embarked on a deep dive into the existing procedures and systems. He emphasizes the value of having a clear understanding and the ability to trend data, showcasing Unifize's instrumental role in bringing clarity and improved decision-making.
Watch Video
How Unifize links raw materials to lots, formulas and finished products
Jesse Kolstad highlights Unifize's capability to seamlessly link raw materials to lots, formulas, and finished products. Providing a comprehensive view of the production process, Unifize ensures unparalleled traceability and accountability, enhancing production oversight at Biovation Labs.
Watch Video
Get to market faster by enabling agility and overcoming fear
Denis Machoka emphasizes the importance of overcoming the inherent fear of new technologies in the quest for compliance. He advocates for education to bridge the gap between rapid societal advancements and slower professional tech adaptations, stressing the need for agility in today's fast-paced world.
Watch Video
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.
Watch Video

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.