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

00:00 - 00:15
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.



00:15 - 00:25
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.



00:25 - 00:46
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.



00:46 - 00:52
So I think Adaptive Health is unique in that quality is a part of the product development process from the start.



00:52 - 01:14
So Natalie, she basically develops the formulation through communications with our upper management of what kind of idea of a product that she wants to create. So she researches ingredients that achieve whatever they're going after. And then once she identifies those raw materials, I'll jump in and help get all the raw material documentation to make sure everything aligns with in our standards.



01:14 - 01:46
So GMO, gluten-free, make sure there's no allergens. There is a lot of, a lot of statements that I collect, upload all of that into Unifize right now. And then we kind of go through, make sure the checklist is fully complete and meets all of the requirements that we have, and then we have all the details and then both Natalie and I approve the raw materials, make sure the potencies and everything that align are squared away and then from there kicks it off into our request for quote module, which ties in the ingredient and the master formula all together for the Biovation team to go ahead and quote it.



01:46 - 01:58
They can already see which raw materials are winning the source, pricing is tied to the ingredient itself. So from request for quote then we kick it off to the piloting module and then finished good lot where it's approved.



01:58 - 02:05
It’s very easy now than where it used to be, everything was just an email it's everywhere it's all on Unifize now which is nice.

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

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.
00:41
How does collaborative discussions lead to faster decisions
In this testimonial, Seth Bozman explores the dynamic shift in communication within Efco facilitated by Unifize. He points out how the platform encourages active collaboration and discussions, ensuring that issues such as part completion and quality action tickets are addressed promptly. Seth's narrative underscores the value of Unifize in creating a more engaged, responsive, and collaborative workplace, where decisions are made faster and more effectively.
02:07
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.
01:27
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.
03:57
How does Adaptive Health create a product and bring it to the market
In this video, Natalie explains the comprehensive process Adaptive Health employs to bring a new product to market. She covers the stages from initial concept and formulation through to compliance checks, quality control, and final market release. Natalie emphasizes the meticulous attention to detail and the rigorous standards that are upheld throughout the process, showcasing how Unifize plays a pivotal role in ensuring efficiency and adherence to regulatory requirements.
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.
01:49
Why Slack is not the best system for managing quality
In this detailed video, Erica delves into the unique messaging and document management features of Unifize. She explains how Unifize facilitates specific conversation threads, such as for finished goods, artwork, or ingredients, allowing immediate access to relevant documents within these discussions. Erica contrasts this with Slack, where uploading and sharing documents is more cumbersome and lacks the context provided by Unifize's integrated system. She emphasizes how Unifize's layout enables users to quickly view dialogues and understand ongoing issues without extensive explanations. Additionally, Erica highlights Unifize's ability to hold users accountable and convey urgency in tasks, a feature she finds lacking in Slack. This video effectively showcases how Unifize streamlines communication and document management, enhancing productivity and clarity in workplace collaborations.
03:29
Impact of lockdown on cosmetic ingredient manufacturers
This video discusses the significant challenges and adjustments faced by cosmetic ingredient manufacturers during the lockdown. It highlights how the industry navigated supply chain disruptions, shifts in consumer behavior, and the rapid pivot to digital platforms to maintain operations and meet demand.
02:03
How Unifize's configurability helped us fight the resistance to change
Tedd Carr highlights the configurable nature of Unifize as a pivotal element in overcoming resistance to change at The Will-Burt Company. He values the software's adaptability, allowing for a familiar feel akin to their previous systems, thus simplifying the transition. The Unifize platform mirrors their old forms but with a new, conversation-driven approach, resulting in a smoother learning curve and quicker adoption among staff, leading to a more relaxed and progressive work environment.
00:57
Doing 95% internal audits remotely with Unifize
The Will-Burt Company's pivot to remote operations, as narrated by Tedd Carr, showcases the agility afforded by Unifize. Amid travel restrictions, they've successfully shifted 95% of internal audits to a remote format, utilizing Unifize to maintain stringent compliance without the need for physical presence in their Tulsa location. This transition underscores Unifize's conversational-driven software's strength in facilitating seamless and efficient audit processes.
02:36
Reducing redundancies and getting things done faster with Unifize
In this video, Wilson highlights how Unifize has transformed their approach to product quality and development processes. By integrating Unifize early in the R&D phase, they've significantly enhanced discussions around quality, compliance, and consumer trends. This centralization has streamlined workflows, reduced the need for excessive meetings, and facilitated better communication across departments. The platform's ability to serve as a single repository for all relevant information has led to a notable improvement in efficiency and quality of life for the team, demonstrating Unifize's impact on eliminating redundancies and speeding up project completion.
01:47
Reducing the time to resolve customer complaints on Unifize
Jesse Kolstad highlights how Unifize expedites the resolution of customer complaints. Offering tools for rapid issue identification and fostering team collaboration, Unifize streamlines the complaint resolution process, ensuring accountability and efficiency in addressing customer concerns.
00:30
How to standardize institutional knowledge for enhancing clarity
Seth Bozman shares insights into how Unifize has played a crucial role in capturing and standardizing institutional knowledge at Efco. He highlights the challenge of relying on knowledge passed down through years of experience and how Unifize's structured approach to operational procedures has facilitated better decision-making. This video demonstrates Unifize's impact on preserving critical knowledge and ensuring it's accessible to all, thereby speeding up processes and enhancing efficiency.
01:01
Collaborating right from the shop floor using Unifize
Dave Anderson showcases the power of Unifize's mobile application, revolutionizing real-time collaboration directly from the shop floor. He highlights how team members can instantly join discussions, contribute insights, and make decisions without being tethered to a desktop computer. The introduction of barcodes on paperwork, a minimal but crucial use of paper, allows anyone to scan and immediately access the relevant discussion on Unifize. This feature underscores the platform's commitment to enhancing efficiency and communication across various departments, making it a game-changer for operational workflows.
03:38
Change control with Unifize
Wilson explains the change control process within Unifize, highlighting how the platform facilitates smoother transitions and better communication. This approach ensures that all modifications are adequately reviewed, approved, and documented, contributing to continuous improvement and operational integrity.
00:24
Unifize - a validated QMS software
Denis Machoka elaborates on the validation credentials of Unifize as a QMS software. He underscores that Unifize is pre-validated, comes with a comprehensive validation package, and emphasizes the simplicity of its configuration, stressing the need for proper documentation.
01:23
Why Unifize was such a breath of fresh air in the quality management world
This video highlights Unifize's innovative impact on the quality management sector, praising its user-friendly interface, flexibility, and comprehensive features. The speaker describes how Unifize stands out from traditional QMS solutions by encouraging proactive engagement and simplifying complex processes, making quality management more accessible and effective.
01:19
My role and prior MedTech QMS experience
Clarissa Archer, a Quality Assurance Engineer at Harmonic Bionics, shares her decade-long journey in the medical device industry. Beginning in product development, she transitioned to quality assurance, drawn by her passion for risk analysis and compliance. With a biomedical engineering background from Texas A&M, she emphasizes the importance of hands-on experience in understanding regulations in the medical device space.
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.
02:27
How Unifize ensures everyone is trained on the right version of documents and SOPs
Jesse Kolstad sheds light on the intricacies of document control, a critical component across regulated industries. While debunking common myths, he underscores the importance of more than just maintaining master copies. With Unifize, the emphasis is on ensuring that everyone in the organization is well-trained and aligned with the most recent versions of documents and SOPs, guaranteeing compliance and 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
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.