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.
Transcript

00:00 - 00:16
The relationship I've had with a quality management system in my previous roles has more or less been: Get your design together, throw it over the fence, and two or three weeks later you might get an email saying that you need to add some field to a part property or something like that.



00:16 - 00:45
There's no communication back and forth. As far as I knew, it was just sending parts out into the void. With a smaller company, you cannot do that, right? There's nobody in the void to send it to. And more importantly like that, those two weeks you don't have. Right. We need to get this stuff out now. And So what I like about Unifize is that I see exactly what's happening with the information or the designs that I am putting forward to get released.



00:45 - 01:18
Everybody's looking at the same files. Everybody has the same chat history. There's no obfuscation of what's going on. And so I think having a common understanding of the process that our parts designs, our deviations, quality notifications are going through is really useful. And I think that, it is a time saver for me because ultimately I need to think about the system less and I can just focus on my job more, right?



01:18 - 01:42
As an engineer, right, my job is to solve problems with the product and make sure that we have a good saleable device that hits the market and does what it needs to it. That helps people. And if I do that, if I do my job as the engineer, the way that we've set up our QMS with Unifize I'm just writing what I've done and that's the process, right?



01:42 - 01:44
I think that's pretty useful.

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

About Denis Machoka and his role as VP of Quality at Harmonic Bionics
Denis Machoka, VP Quality at Harmonic Bionics, shares his evolution from a scientist with a background in chemistry and biology to a Quality Systems expert. He delves into his experiences in laboratories, IT systems implementation, and his expertise in qualifying systems within regulatory frameworks.
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.
How to make facing FDA audits easy
Clarissa Archer talks about the daunting experience of preparing for audits, especially from rigorous bodies like the FDA. She stresses the importance of a robust documentation system, serving as a "source of truth" during these audits. With Unifize, they could effortlessly produce, present, and recall documentation, simplifying the audit process and instilling confidence in their decisions and actions.
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.
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.
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.
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.
Managing Product Lifecycle with Unifize
Delving into Harmonic Bionics' evolution, Michael Hogan speaks about the company's transformation from a small team of college students to a structured entity. As they scaled, the pressing need for robust documentation and product management became evident. The journey underscored the significance of an efficient QMS, ensuring streamlined operations and clarity in decision-making.
Near instant implementation and adoption of Unifize
Jesse Kolstad lauds Unifize for its intuitive design and quick adoption. With tools that foster user engagement and autonomy, Unifize integrates smoothly into Biovation Labs' daily operations.
The ROI of Quality Management Systems
Jesse Kolstad delves into the significant ROI of quality management systems, underscoring efficiency gains and cost savings. Unifize emerges as a pivotal tool in optimizing the ROI of quality management, demonstrating tangible benefits at Biovation Labs.
Wear a seatbelt using Unifize to avoid accidents and save money
Drawing a parallel with wearing a seatbelt, Jesse Kolstad elucidates how Unifize serves as a preventive tool, averting operational mishaps at Biovation Labs. Ensuring safety and compliance, Unifize's proactive features lead to significant cost savings by forestalling potential issues.
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.
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.
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.
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).
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 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.
Accelerate any process on Unifize: Quotes, Formulas, Lot Release, Raw Material, Specs and Approvals
In a regulated environment, Unifize streamlines processes from raw materials to product releases. Jesse Kolstad highlights its flexible approval workflows, instant quotation transfers, and collaboration features, emphasizing how Unifize instills confidence in approvals and accelerates operations 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.
They key to configurability- make it simple & easy
Denis Machoka extols the straightforward configurability of Unifize, contrasting it with the complexities of other systems. He appreciates its pre-configured design, likening it to object programming. Denis believes Unifize's inherent simplicity is testament to its creators' deep industry understanding and their aim to simplify user experience.

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.