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.
Transcript
Related Videos
Unifize Results
10x
Speed to compliance
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
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
01:42
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.
03:00
What attracted us the most about Unifize
Tedd Carr recounts The Will-Burt Company's extensive search for the ideal quality software, vetting over 30 options before discovering Unifize. The decisive factor was Unifize's user-friendly interface, akin to social media, that required minimal training and ensured swift adoption across their teams. This ease of use, combined with comprehensive onboarding support at no extra cost, distinguished Unifize as the superior choice, fostering its enthusiastic embrace within the company.
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.
01:08
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.
01:41
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.
01:15
Resolving non-conformances in just hours with Unifize
In this video, Mikala discusses how Unifize has revolutionized the handling of non-conformances in their products, reducing resolution time from days to mere hours. She highlights the software's ability to initiate non-conformance processes directly and efficiently, linking all relevant data to the identified issue. Mikala emphasizes the ease with which users can trace raw materials and other factors contributing to the non-conformance, leading to a significant decrease in the time spent documenting and resolving such issues.
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.
01:25
Enhancing traceability and improving visibility and accountability with Unifize
This video showcases Unifize's capabilities in boosting traceability, visibility, and accountability within organizational processes. The speaker illustrates how the platform fosters a transparent environment where tasks and responsibilities are clear, enhancing overall operational efficiency.
00:45
Fostering a culture of continuous improvement with Unifize
Mikala shares her experiences in fostering a culture of continuous improvement at her organization using Unifize. She details how the platform has been instrumental in promoting collaboration, streamlining processes, and encouraging proactive problem-solving. Mikala underscores the importance of Unifize in facilitating a more dynamic and responsive approach to quality management, which has been pivotal in driving continuous improvement and operational excellence.
01:34
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.
02:47
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.
01:51
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.
01:13
Reviewing documentation in half the time with Unifize
In this informative segment, Erica enthusiastically discusses how Unifize revolutionizes supplier audits and ingredient management. She delves into the platform's intuitive interface, allowing for easy document uploads and efficient tracking. Erica emphasizes the significant time-saving benefits, noting how Unifize cuts down task durations dramatically with its customized checklist feature. She illustrates the stark contrast between the traditional, time-consuming methods and Unifize's streamlined approach, concluding with praise for the platform's drag-and-drop functionality. This segment effectively highlights Unifize's transformative impact on simplifying and accelerating quality control processes.
00:34
What collaboration means to Dave
In this video, Dave Anderson passionately discusses the essence of collaboration through Unifize. He emphasizes the significance of having smaller, focused groups tackling specific issues such as scrap or rework. Dave appreciates how Unifize facilitates open discussions, allowing for collective problem-solving where no single individual holds all the answers. This collective approach brings diverse ideas to the forefront, enhancing the problem-solving process. Dave's testimonial underscores the value of collaboration in fostering a more innovative, efficient, and inclusive work environment.
02:42
About Harmonic Bionics- a robotics MedTech company in Austin, Texas
Harmonic Bionics, based in Austin, Texas, designs robots to assist in upper chest healing for patients with mobility challenges, especially those recovering from strokes. By facilitating limb movements, these robots aid in retraining neural connections. The company is FDA-registered and collaborates with the University of Texas for research.
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.
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.
00:39
Enabling collaboration across multiple shifts
Dave Anderson highlights Unifize's role in fostering seamless collaboration across multiple shifts at Efco. He introduces a novel discussion process within Unifize that allows for more than just quality action tickets, addressing the challenge off-shifts face without direct engineering support. By initiating discussion boards for any arising issue, supervisors can communicate problems in real-time, ensuring that the first shift can immediately see and decide on the necessary actions. This approach has significantly improved decision-making and problem resolution, enhancing operational efficiency across shifts.
02:28
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.
00:56
Why it was easy to win the hearts and minds of engineers about Unifize
Denis Machoka reveals how Unifize's simplicity and instant information accessibility resonated with engineers at Harmonic Bionics. The platform's integrated conversations enabled engineers to quickly grasp expectations and engage in substantive discussions, streamlining communication and boosting efficiency.
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.
