Director of Quality Assurance, Adaptive Health

Mikala Hukka

Mikala is an experienced Quality Director with over 10 years experience working in the dietary supplement industry. Extensive knowledge of quality assurance/quality control processes, requirements, and regulatory compliance.

About Adaptive Health
Adaptive Health, a key player in the dietary supplements market, is dedicated to producing high-quality, innovative products. Emphasizing safety and regulatory compliance, they utilize advanced tools like Unifize for efficient quality management. Their commitment to rigorous quality control and innovation sets them apart in the health and wellness industry.
Nutritional Supplements
Charlotte, North Carolina, United States of America
How this Director of Quality at a Dietary Supplements manufacturer improved process cycle times and got to market faster with Unifize
In this video, Mikala provides an overview of her professional journey and her current role at Adaptive Health. She shares insights into her responsibilities as the quality director, overseeing product development and marketing for dietary supplements. Mikala reflects on the growth of Adaptive Health and her contributions to building the quality department, emphasizing the importance of quality in product development. She also discusses the role of Unifize in streamlining processes and improving communication, crucial for the company's rapid growth and success.
How this Director of Quality at a Dietary Supplements manufacturer improved process cycle times and got to market faster with Unifize


Mikala Hukka, the Director of Quality Assurance at Adaptive Health, shares her positive experiences with Unifize, emphasizing its crucial role in streamlining compliance and documentation processes in the context of the stringent standards of the dietary supplements industry.


Transitioning into a more compliance-focused role, Mikala faced significant challenges in managing change control and documentation. The existing systems at Adaptive Health were inefficient, characterized by lost documents and ineffective communication, which were major obstacles in the rapidly evolving dietary supplements sector.


Adaptive Health, under Mikala's guidance, adopted Unifize after assessing various quality management systems. Unifize stood out for its customizable nature, particularly its ability to handle comprehensive compliance needs, such as electronic signatures and document management, in line with industry standards.

Ease of Use

Mikala found Unifize to be remarkably user-friendly, allowing her and her team to tailor the system to their unique needs. This adaptability was key in efficiently organizing and managing critical documentation and quality processes.

Communication and Collaboration

The introduction of Unifize transformed internal communication at Adaptive Health. It centralized and streamlined discussions, feedback, and approvals, thereby reducing reliance on less efficient communication methods like emails and informal chats.

Documentation and Compliance

Unifize proved instrumental in producing clear, audit-ready documentation with complete audit trails. This capability was pivotal during compliance audits, as it demonstrated the detailed rationale behind each decision and action.


With Unifize, Adaptive Health saw a remarkable transformation in handling change requests and managing compliance processes, significantly reducing the time and effort involved. The system was quickly adopted by the team, recognizing its potential to maintain compliance without sacrificing efficiency.

Professional Preparedness

The comprehensive record-keeping and history provided by Unifize equipped Mikala and her colleagues with the necessary tools to confidently and promptly address auditors' questions, eliminating the previously common frantic search for information.

Regulatory Alignment

Unifize not only simplified compliance with FDA standards but also aligned with other relevant regulations in the dietary supplements industry, demonstrating its extensive applicability.


Unifize has become an essential tool at Adaptive Health, significantly enhancing compliance, simplifying documentation processes, and ensuring team alignment. Its adaptability and ease of use have made it a cornerstone in Adaptive Health's focus on quality and regulatory compliance, proving that efficiency and compliance can coexist successfully in the fast-paced dietary supplements industry.

[00:00 - 00:13]
By holding a product in quarantine for a month, which is what we used to do, now we have hours and we have the issue resolved. And so there's no delay, no back orders on the market for getting product out the door, which of course saves us money in the end.

[00:13 - 00:17]
I would say that roughly 80% of my day to day is spent in Unifize.

[00:17 - 00:25]
So with Unifize we've been able to reduce the turnaround time on all of our quality processes by roughly 25 to 75%.

[00:25 - 00:31]
And I would say that's probably saved us 2 to 4 quality personnel employees.

[00:31 - 00:39]
Finished good lots for example I think Unifize has sped up our finished good lot from half a day to maybe 10 minutes.

[00:39 - 00:46]
Non-Conformances could take anywhere from days to weeks. And again, I would say that's reduced about hours now.

[00:46 - 00:58]
So if we didn't have Unifize processes would be a lot less streamlined. There would be a lot of redundancy in the data that we currently have because right now it's all in one repository versus individual locations.

[00:58 - 01:07]
Without Unifize, I feel like there would be a lot more meetings and so less time spent focusing on the more important aspects of the business structure.

[01:11 - 01:28]
I’m Mikala Hukka. I work for Adaptive Health. I am currently the quality director over the VMS division. So we have several subsidiaries that report under our Wellful line and in our branch we do product development and marketing for dietary supplements.

[01:28 - 01:38]
And when I first started at the company, which was six years ago now, it was a team of 20 of us and there was no product development team or quality team that even existed on this side.

[01:38 - 01:59]
So I was brought on board to help build up the entire quality department to what it is today. And since then, we've acquired numerous companies, Renew Vitality, Healthy Directions, Biovation being one of them, and we've merged with Nutrisystem and then Jenny Craig as well. So now it started as 20 plus employees, we’re over 800 now.

[01:59 - 02:05]
So I think Adaptive Health is unique in that quality is a part of the product development process from the start.

[02:05 - 02:19]
Having a greater say in the raw materials that we were sourcing, being able to vet them and make sure we're using high quality materials that our team is identifying rather than commodity ingredients that a lot of manufacturers use that get cheap.

[02:19 - 02:33]
We have a greater say in that. And then seeing it all the way from cradle to grave on how their manufacturing a process is making sure the right quality processes are in place. So we're producing high quality, best possible products to our customer, at the end of the day.

[02:33 - 02:43]
It’s very easy now than where it used to be, everything was just an email it's all on Unifize now which is nice.

[02:43 - 02:56]
I think it's because there's so many hands in the pot at once, especially with a company in its growing this quickly. To have everybody on the same page at the start is almost crucial in order to have a successful product launch.

[02:56 - 03:07]
I mean, it reduces the number of meetings, it's streamlined the processes, you have more time to dedicate to other areas of the product launch process. I would say it expedites everything substantially.

[03:07 - 03:18]
And the beauty of Unifize is it afforded us the opportunity to collaborate across organizations too. So if we'd sourced one material and approved it, our sister company can see that.

[03:18 - 03:27]
They have the same requirements as us. So rather than doing that own investigative work on their end, they can easily see the one that we've used and kind of pull it into their resource guide as well.

[03:27 - 03:36]
It's hard to say from cradle to grave the redundancies, but an individual task, I would say at least 25% to 75% in each area, it's probably been decreased.

[03:36 - 03:43]
Manpower I think, would be the biggest saver there.

[03:43 - 03:54]
When you use Slack and Teams, it separates the collaborative portion from the data. And it also doesn't afford you to have all of the linkages that Unifize lets you.

[03:54 - 04:02]
So with Slack, you could upload a word document but you can’t upload the finished good lot, which automatically will tie you to raw materials and the testing.

[04:02 - 04:19]
It all is like a domino effect in Unifize, which I would say the Slack and Teams is just stagnant documents. You actually have to go find them individually one by one. Where Unifize allows that collaborative space, but it also ties in all the data with it.

[04:19 - 04:35]
You're not looking at your email or somewhere in Excel, Dropbox, SharePoint, whatever it may be, to find the information they're talking about via Slack, its there right next to you in the same window, the same frame when you're making these discussions. Slack and Teams cannot do this.
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.
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Speeding up finished good lot process from half a day to 10 minutes
Mikala shares her remarkable experience with Unifize, focusing on its impact in optimizing the finished goods lot process. She illustrates how the process duration dramatically decreased from half a day to a mere 10 minutes, showcasing Unifize's efficiency. She also highlights the reduction in the need for quality personnel by 2 to 4 employees, stressing the software's significant role in streamlining operations, reducing manpower requirements, and enhancing overall productivity.
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Experience with MasterControl
In this detailed account, Mikala compares her experiences with MasterControl and Unifize. She outlines the challenges faced with MasterControl, such as its complex, time-consuming processes, and inefficiency. Mikala then contrasts this with the user-friendly and effective operations provided by Unifize, emphasizing its streamlined approach and significant improvements in operational efficiency, process simplification, and overall user satisfaction.
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Experience with UniPoint
Mikala provides an in-depth analysis of her journey with UniPoint, discussing its inefficiency and cumbersome operational process. She contrasts these experiences with the seamless, intuitive, and effective functionality of Unifize. This comparison effectively demonstrates Unifize's superiority in user experience, operational efficiency, and its ability to provide a more streamlined and effective approach to quality management processes.
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What made us switch from MasterControl to Unifize
In this comprehensive narrative, Mikala explores the decisive factors that led to the switch from MasterControl to Unifize. She discusses the limitations and challenges she faced with MasterControl, including its inefficiency and user-unfriendliness. Mikala then delves into the aspects of Unifize that prompted the change, such as its innovative approach, user-centric design, and efficiency, which have significantly improved their operational processes and overall workflow management.
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How long did it take to get up and running with Unifize
Mikala discusses the quick, intuitive setup process of Unifize and contrasts it with the lengthy, complicated setups of other systems. She highlights the system's immediate usability and minimal onboarding requirement, emphasizing its efficiency and user-centric design. Mikala also touches upon the ease of integrating Unifize into their existing workflows, the smooth transition experienced by the team, and how the software's intuitiveness has enabled quick adoption and immediate improvement in their operational processes.
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Why Slack and Teams can't replace a collaborative eQMS
In this insightful video, Mikala explains why Slack and Microsoft Teams cannot replace a collaborative eQMS like Unifize. She discusses the limitations of these platforms in handling quality management processes, emphasizing their lack of specialized features for tracking, auditing, and maintaining compliance. Mikala highlights how Unifize offers a more integrated and comprehensive solution, tailored to meet the specific needs of quality management, thereby enhancing efficiency and ensuring compliance.
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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.
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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.
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How big is Adaptive Health in the Dietary Supplements market
Mikala discusses the significance of Adaptive Health in the dietary supplements market. She talks about the company's market position, its range of products, and its commitment to quality and compliance. Mikala highlights how Unifize has been a key tool in maintaining their competitive edge and ensuring consistent quality in their product offerings, thereby solidifying their market presence.
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What are the compliance standards followed at Adaptive Health
In this video, Mikala outlines the compliance standards followed at Adaptive Health. She delves into the various regulatory requirements they adhere to and how maintaining these standards is critical for their operations. Mikala explains how Unifize plays a vital role in ensuring compliance, managing documentation, and streamlining processes to meet these rigorous standards effectively.
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Why Mikala uses Unifize for 80% of her work
Mikala shares her reliance on Unifize for a significant portion of her work, detailing how the platform supports 80% of her daily tasks. She discusses the diverse functionalities of Unifize that facilitate efficient management of quality processes, documentation, and compliance. Mikala emphasizes how Unifize enhances her productivity, ensures accuracy, and simplifies complex processes, making it an indispensable tool in her professional routine.
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How approvals in Unifize helped us collaborate across organizations and get things turned around faster
Mikala discusses how Unifize's approval features have enhanced collaboration across different organizations and expedited turnaround times. She highlights the platform's ability to streamline approvals, improve communication, and facilitate quicker decision-making. Mikala shares specific instances where Unifize's efficient approval processes have led to faster resolutions and better collaboration, underscoring its impact on operational efficiency.
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Centralizing master formula and reducing redundancies with Unifize
In this video, Mikala explains the benefits of using Unifize to centralize the master formula and reduce redundancies. She discusses how the platform has streamlined their formulation processes, improved accuracy, and reduced errors. Mikala highlights how this centralization has led to better resource management and efficiency in their operations, emphasizing the role of Unifize in enhancing productivity and reducing waste.
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How Unifize helped us streamline Change Requests
Mikala shares her experience with streamlining change requests using Unifize. She talks about how the platform has simplified the process, improved tracking, and increased transparency. Mikala emphasizes the importance of efficient change management in maintaining product quality and compliance, and how Unifize has been instrumental in making these processes more manageable and effective.
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Resolving Out of Specs and getting the product to market faster with Unifize
In this detailed video, Mikala discusses how Unifize has streamlined the process of resolving out-of-specification (OOS) issues. She explains how the platform has reduced the time products are held in quarantine, from a month to mere hours, thereby preventing delays and backorders. Mikala highlights the cost savings and efficiency gains achieved through Unifize, showcasing its significant role in getting products to market faster while maintaining quality standards.
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Document revisions made simple with Unifize
Mikala, in this comprehensive video, explains how Unifize has simplified the process of document revisions. She highlights the platform's ability to streamline document management, making revisions more efficient and traceable. Mikala also discusses the impact of these capabilities on improving compliance, reducing errors, and enhancing overall operational efficiency. She emphasizes Unifize's role in facilitating better collaboration and communication, making it easier for teams to manage and revise documents in a cohesive and organized manner.
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