How Unifize makes audits easier
Jesse Kolstad highlights the revolutionary change Unifize brought to Biovation Labs' internal audit process. The platform facilitates direct capture and storage of visual evidence like photos, ensuring context and clarity. Drawing a contrast with past practices of manual note-taking and subsequent transcription, Jesse appreciates Unifize's real-time documentation that eliminates back-and-forth and enhances audit efficiency.
Transcript

[00:00 - 00:06]
So we use Unifize for our internal audits and we we do a monthly we have our internal audit conversation type and Unifize.



[00:06 - 00:30]
And what what's amazing about that is we're walking my team walking through where they take pictures and they store it with the audit. They say, Here's what I saw and they add the context because at other companies and other places I've been, you'll do the audit, you'll make some notes on a piece of paper, then you'll go back to your desk and you'll, if you have time in my case, get to it when you could and maybe, Oh, shoot, I'd rather have an image of it.



[00:30 - 00:47]
And then you have to go back out and hopefully it sounds weird to say, but hopefully the problem's still there so that you can capture, capture the images if you missed them. But here I'm doing it real time while we're walking around on a tablet and we're saying, Here's what I saw, here's the image for context. Here's my explanation of why it's a problem.



[00:47 - 01:03]
And moreover, I can assign we use tasks and so I can assign an owner, I can assign a task, I can assign a due date. So let's get this resolved. And then they come back. And when it's resolved, not only do they, the owner gets an alert that says, Hey, go do this. Then when they do it, they say, I did this.



[01:03 - 01:28]
And through the the actually what's been wonderful, especially recently, is the workflow signatures that Unifize is given us so that that person signs saying I did it and then it goes back to whoever we build into the checklist to say, hey, this is done and and quality would go out and then confirm it. And that chain of command and custody and responsibility and accountability is is effortless



[01:28 - 01:52]
So the next major step I want to take with the Unifize team is to be able to scan that finished product and connect these employee training records and employee badges to that finished goods. So I can see who made it when they made it, how they made it, and all the way back to the ingredients and the employees and their training records and and that level of visibility and traceability is second to none.



[01:52 - 02:21]
And it affords me this incredible advantage because a lot of people will sell you these concepts, but it's window dressing. But the fact is here I actually have the meat and potatoes to back it up in the sense I want to get to a place where for my regulatory audits, for my my compliance audits, I would love and I think we could do it to use Unifize to be able to just hand them a tablet and to go nuts out there, which anybody who works in quality will tell you sounds ludicrous.



[02:21 - 02:29]
But with what we have here and what Unifize has helped us build, I'm not scared of that. I actually would welcome that.

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

01:54
Trends in New Product Development
Wilson explores current trends in new product development within the cosmetics industry, focusing on sustainability, consumer-driven customization, and technological innovations. These trends underscore the industry's shift towards more eco-friendly practices and personalized consumer experiences.
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.
03:06
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.
03:08
How was Efco handling Returned Goods process before versus after Unifize
In this video, Carol Wilson from Efco vividly details the transformation in handling the Returned Goods process before and after adopting Unifize. She describes the cumbersome, error-prone system of managing returns via Excel, involving complex tabs and manual notifications, which often led to delays and communication breakdowns. Carol contrasts this with the streamlined, efficient process enabled by Unifize, where automated notifications and a centralized system ensure quick, accurate handling of returns, significantly improving accountability and operational efficiency. This change not only saved time but also enhanced collaboration across departments.
01:52
How Unifize helps save time and get things done faster
In this video, Michael from Harmonic Bionics celebrates the transparency and coherence Unifize offers. He values the platform's ability to keep everyone synchronized, viewing the same documents and chat histories. This clear and shared understanding of processes, from part designs to quality notifications, not only fosters efficiency but also lets Michael concentrate more on his primary responsibilities, enhancing productivity.
01:52
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.
01:51
The ROI of a collaborative, configurable eQMS
Denis Machoka elaborates on the ROI derived from Unifize as a collaborative eQMS. He underlines that true ROI is reflected in compliance, data accessibility, and the defense of information. Denis commends Unifize's capabilities in showcasing regulatory control and its adaptability to adjust control levels based on data sensitivity.
02:22
About Erica and her role at Adaptive Health
In this comprehensive video, Erica Bennerman introduces herself as a Quality Assurance Specialist at Adaptive Health. She outlines her crucial role in ensuring that products meet customer expectations and adhere to stringent quality standards. Erica explains that Adaptive Health specializes in producing nutritional supplements, where her department focuses on scrutinizing product presentation, artwork, and ingredient compliance. She emphasizes the importance of meeting FDA and General Manufacturing Practices (GMP) standards and maintaining essential documentation for potential audits. Erica shares her professional journey, starting as an Executive Assistant and transitioning into quality assurance, highlighting Adaptive Health's supportive environment for growth and exploration. This video effectively presents Erica's commitment to quality and the rigorous processes at Adaptive Health to ensure superior product standards.
02:33
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.
01:42
What are the top reasons a product formulator should consider using Unifize
In this video, Natalie outlines the top reasons why a product formulator should consider using Unifize. She emphasizes the platform's ability to maintain and consolidate documentation effectively, ensuring that changes are documented and visible to all users. Natalie highlights how Unifize streamlines the ingredient review process and assists in the creation of master formulas. She underscores the disaster prevention aspect of Unifize, noting that without it, operations would be significantly set back, emphasizing its critical role in maintaining order and efficiency in their processes.
01:18
Getting better visibility using Unifize Dashboards
Clarissa enthusiastically discusses the advantages of Unifize Dashboards in improving visibility and workflow management. She describes how custom dashboards can alert specific teams about pending tasks, like change orders awaiting implementation. Clarissa appreciates the dashboards' ability to prioritize tasks and centralize information, highlighting their role in streamlining operations and fostering team collaboration.
02:39
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.
00:56
What happens when QA people develop software
This video offers insights into the unique perspective brought to software development by quality assurance professionals. It suggests that a focus on collaboration and flexibility, typically lacking in traditional QMS software, is essential for creating a system that truly meets the needs of all users. The speaker reflects on the importance of designing quality management tools that are not only about data storage but also about enhancing the user experience and operational efficiency.
01:42
About Dave
In this video, Dave Anderson, Quality Assurance Manager at Efco with 20 years of tenure, shares his journey from the shop floor to senior supervisory roles before stepping into quality assurance. With a passion for continuous improvement and an improvement-minded approach, Dave emphasizes the importance of striving for perfection in quality management. His experience highlights the value of shop floor knowledge in identifying root causes and implementing sustainable solutions, underscoring the significant impact of hands-on experience in quality roles.
00:55
Unifize's lightning fast customer support
Jesse Kolstad lauds the unparalleled responsiveness of the Unifize support team. He recounts instances where he received almost instantaneous assistance, highlighting their record response time of just 12 minutes. Jesse values the platform's collaborative capabilities, allowing him to make real-time changes with both his team and the Unifize support team. The genuine partnership feeling resonates throughout his experience, showcasing their commitment to customer success.
00:56
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.
01:24
What is the challenge with managing a QMS actively
In this video, Wilson delves into the challenges of actively managing a Quality Management System (QMS). They reveal how manual processes, over the years, made the QMS cumbersome, deterring the team from utilizing it fully for new product development and quality control. Highlighting a shift towards an electronic QMS to mitigate these issues, the speaker underscores the importance of a QMS in improving business operations, controlling quality output, and fostering continuous improvement, stressing that an efficient QMS is vital for operational success.
02:11
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.
01:39
Future of Unifize in Efco
Dave Anderson explores the exciting prospects of Unifize within Efco in this forward-looking video. He discusses the evolution of quality management processes facilitated by Unifize, highlighting the platform's ability to enable trend spotting and proactive responses to various challenges. Dave shares insights on integrating Unifize across different company operations, including warranty claims and quality records management, and addresses the ongoing transition from paper-based to digital systems. This journey with Unifize not only aims to enhance operational efficiency but also to lay the groundwork for future innovations in managing company workflows.
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.

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.