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

01:07
How did you discover Unifize
Dave Anderson shares the journey of discovering Unifize through a diligent search for a quality management system that could transition Efco from traditional, paper-based processes to a more efficient, cloud-based solution. Starting with Google, they came across Software Advice, which recommended several QMS options, including Unifize and QT9. Dave highlights the clunky and outdated methods of record-keeping they wanted to move away from, leading them to prioritize cloud-based solutions. Ultimately, the choice was made for Unifize, largely due to its superior collaboration features over the competition.
01:12
Onboarding and adopting Unifize
This video outlines the swift and efficient onboarding process to Unifize for managing corrective actions, risk assessments, and change control within their quality management system. Highlighting the collaborative effort with the Unifize team, the speaker details how they were able to upload historical data and fully implement these crucial aspects within just three to four weeks—a timeline significantly shorter than anticipated. This rapid deployment, compared to previous experiences with other systems, underscores Unifize's ease of adoption and its immediate impact on enhancing the company's quality management processes.
06:33
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.
01:48
About Tedd and The Will-Burt Company
Tedd Carr, with 40 years at The Will-Burt Company, oversees a broad quality assurance and control remit that spans beyond the traditional confines of the department. His role touches all company areas, emphasizing the diverse and complex quality demands of their varied customer base in sectors such as aerospace and military, which presents a significant challenge in meeting each sector's unique requirements and expectations. The Will-Burt Company, an employee-owned enterprise, prides itself on a century of business, specializing in proprietary products and services for emergency communications, warfare, and payload elevation, as well as offering comprehensive manufacturing services.
01:55
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.
03:13
How Unifize's collaboration empowers continuous improvement
Jesse Kolstad heralds Unifize's transformative impact on collaboration at Biovation Labs, empowering continuous improvement through open communication. By breaking down silos and fostering cross-functional collaboration, Unifize establishes real-time feedback loops, ensuring alignment with company objectives and facilitating rapid growth.
01:32
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.
02:15
Three reasons why Unifize is the easiest QMS- Security, simplicity, compliance
Denis Machoka advocates for Unifize as a QMS, praising its exceptional ease of implementation and intuitive design. Drawing a comparison with other renowned systems, he emphasizes Unifize's simplicity and rapid setup, making it a standout choice in the realm of quality management syst
01:14
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.
02:42
Why you can't use Slack and Teams to build life science products
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.
02:10
Importance of Approvals
The video emphasizes the critical role of approvals in the operational workflow, showcasing how Unifize simplifies and speeds up the approval process. It highlights the platform's ability to streamline decision-making and ensure compliance, thereby enhancing overall efficiency and reducing time to market for new initiatives.
01:25
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.
01:13
Optimising employee efficiency by setting priorities using Unifize
Seth Bozman discusses how Unifize has optimized employee efficiency at Efco, particularly among supervisors. He emphasizes the platform's role in prioritizing tasks and ensuring that rework and remake cards are processed in a timely manner, reducing unnecessary delays. Seth's account highlights how Unifize supports better resource allocation and task management, contributing to a more efficient operational flow and reducing idle times.
02:10
About Mikala and her role at Adaptive Health
In this video, Mikala introduces herself and elaborates on her role at Adaptive Health. She discusses her responsibilities in overseeing quality management and compliance processes. Mikala explains how her role is crucial in ensuring product quality and adherence to regulatory standards, and she emphasizes the importance of using efficient tools like Unifize to maintain high standards in the dietary supplements market.
02:38
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.
01:08
Moving away from CCPs to Preventative Controls with Unifize
Highlighting the shift to preventative controls, Jesse Kolstad values Unifize's visibility and supplier management. Unifize seamlessly aligns with food safety, optimizing supplier evaluations and quality control at Biovation Labs.
01:10
What does Adaptive Health do
Natalie discusses the core activities of Adaptive Health, highlighting their focus on developing and marketing high-quality dietary supplements. She emphasizes the company's commitment to product safety and efficacy, and their adherence to stringent regulatory standards. Natalie also outlines how Adaptive Health differentiates itself in the market through innovative product development and a strong emphasis on quality control, which is significantly supported by using advanced tools like Unifize.
01:43
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.
04:23
Moving from MasterControl to Unifize
In this insightful video, Erica reflects on her transition from using MasterControl to adopting Unifize for quality management. She shares her journey of growth and adaptation with Unifize, highlighting its superior efficiency in document handling and management. Erica notes the stark contrast between the two systems, pointing out how Unifize simplifies document uploads and centralizes management with just a click. She also touches on the benefits of Unifize's collaborative capabilities, allowing seamless integration with external partners like contract manufacturers. Erica's narrative emphasizes Unifize's user-friendly interface and its effectiveness in streamlining quality control processes, which were previously cumbersome with traditional methods like email or Dropbox.
01:23
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.

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.