Director of Product Development, Adaptive Health

Natalie Jones

Natalie is an expert in crafting novel, scientifically validated formulas that enhance consumer experience, optimize financial performance, and align with strategic goals. Spearhead the success of recognized brands such as Nugenix, Instaflex, Peptiva, Lumiday, Super Beta Prostate, and Ageless Male. Holds two patents in scientific innovation.

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.
Industry
Nutritional Supplements
Location
Charlotte, North Carolina, United States of America
How this Director of Product Development at a fast-growing Nutraceutical company brought accountability and compliance into the system with Unifize
Natalie shares her experience as a formulation scientist in bringing accountability and compliance to a rapidly growing organization using Unifize. She discusses the challenges of managing documentation and ensuring compliance in a complex and dynamic environment. Natalie highlights how Unifize has streamlined these processes, making it easier to maintain accurate records, ensure product consistency, and foster collaborative efforts across various departments, thereby significantly contributing to the organization's growth and compliance standards.
How this Director of Product Development at a fast-growing Nutraceutical company brought accountability and compliance into the system with Unifize

Overview

Natalie, the Director of Product Development at Adaptive Health, shares how Unifize has been instrumental in enhancing their compliance and documentation processes, particularly in meeting the demanding standards of the FDA in the dietary supplements industry.

Challenge

As Adaptive Health transitioned to a more rigorous compliance-focused approach, Natalie faced significant challenges in streamlining change control and improving documentation systems. The existing methods were inefficient, marked by lost documents and cumbersome communication, hindering the agility needed in a fast-growing organization.

Solution

After exploring various quality management systems (QMS), both traditional and digital, Natalie led Adaptive Health in choosing Unifize. Its customizable nature and robust compliance features, including electronic signatures compliant with 21 CFR part 11, made it an ideal fit for their complex needs.

Ease of Use

The user-friendly interface of Unifize allowed Natalie and her team to tailor the system to their specific requirements, efficiently organizing critical documentation without the need to adjust their processes to fit the software, a crucial factor for managing extensive product documentation.

Communication and Collaboration

Unifize transformed the way internal communication was handled at Adaptive Health. It centralized discussions and feedback, significantly reducing dependency on emails and informal communication, which often led to overlooked or forgotten information.

Documentation and Compliance

With Unifize, Natalie’s team could produce detailed, audit-ready PDFs complete with comprehensive audit trails. This feature was key during audits, showcasing clear and precise documentation of every decision and action.

Results

Implementing Unifize led to a significant transformation in managing change requests and compliance processes at Adaptive Health. Processes that previously took weeks were streamlined into days, with the system rapidly adopted by the engineering team for its ability to uphold compliance without compromising on efficiency.

Professional Preparedness

Unifize's detailed record-keeping and history features enabled Natalie and her colleagues to confidently and quickly respond to auditors’ queries, eliminating the previously common frantic search for information.

Regulatory Alignment

Beyond simplifying FDA compliance, Unifize also aligned with relevant ISO standards and regulations crucial in the dietary supplements sector, showcasing its broad applicability and effectiveness.

Conclusion

Unifize has become an essential component at Adaptive Health, significantly enhancing compliance and documentation efficiency. Its adaptability and user-friendly design have established it as a key tool in the company’s shift towards a stronger regulatory focus, proving that compliance and operational agility can successfully coexist in the dynamic world of dietary supplements.

Transcript
[00:00 - 00:25]
If we didn't have Unifize it would create a disaster. We would be back to square one with finding different ingredients, reviewing the documentation, figuring out how ingredients are different or similar to each other, I can't imagine. I think it would be catastrophic. We would have to start from zero with so many different things.

[00:30 - 00:49]
Hi, I’m Natalie Jones. I'm newly appointed as the senior director of Product Development and Quality Assurance for the VMS teams, which includes Adaptive Health and Healthy Directions. So Charlotte and Bethesda offices and I oversee everything involved in end-to-end product formulation.

[00:49 - 01:05]
So our corporate enterprise is Wellful, we create dietary supplements for adults. Target age range is about 45 plus men. Some products are geared towards men, some are women, some are both populations.

[01:05 - 01:10]
We offer different vitamins, minerals and multi ingredient formulas.

[01:10 - 01:21]
We’re direct to consumer as well as a very large presence now in the retail space constantly innovating and creating new products for our customers.

[01:21 - 01:33]
And you know, when I first started here, we had this amount of products. Was it manageable to do it the way we were without any system? Yes.

[01:33 - 01:50]
But as soon as you start finding out that documentation has changed and then you're trying to where are you saving that in the folder? How does everybody know that it's changed? No alerts are going out unless you're sending an email and no one wants a million emails.

[01:50 - 02:00]
So MasterControl is complicated to use. It was hard to find the information that you were looking for. It would just be like a checklist, not the actual documents.

[02:00 - 02:09]
You would have to sift through all of that data to find what you're looking for. It would not be the same organization as in the Unifize checklist.

[02:09 - 02:33]
The collaboration wouldn't be there where you can @ somebody and ask them a question, task them with something, make sure that people are signing off. I don't know how that would be done in Excel spreadsheet it would take weeks longer for certain things. It could take months longer for others.

[02:33 - 02:40]
Once it's in the system that it's in the system. Any changes that are made have to be documented.

[02:40 - 02:53]
So it's brought a lot more accountability and compliance to making sure that the exact formula that we want to be created is being created.

[02:53 - 03:24]
Unifize ensures that everything is being done from A to Z where without it you might do A to J and the other letters would fall off, unfortunately. So it helps to create a consolidated, collaborate collaborative effort to create a product and have it launched and to maintain its cycle.

[03:24 - 03:34]
I can't even imagine the errors that would be made from conversations in Slack. You're not documenting things in a quality management system.

[03:34 - 03:56]
And I would never use Slack for anything besides a quick conversation, you know, in Slack is more of “yo, hey" you're not saying "can you please request a new and updated spec and CoA from this supplier” or, you know, in this ingredient ticket. Some people don't use Slack.

[03:56 - 04:02]
So you would be saying you could send a million messages about a topic and they could never respond.

[04:02 - 04:26]
Where in Unifize, if you @ somebody, they're notified via email. So it's shown in the quality management system as well as email record. It just helps with accountability. Slack, you have no way of tracking what's happening. It would create chaos. And I don't think we would ever be able to launch a product if Slack was used.
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.
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01:26
What would happen in the absence of a collaborative eQMS like Unifize
In this video, Natalie discusses the potential consequences of not having a collaborative eQMS like Unifize in place. She emphasizes the crucial role Unifize plays in maintaining efficient and compliant operations. Natalie points out how the absence of such a system would lead to disorganization, inefficiency, and potential non-compliance issues, highlighting the importance of a centralized and integrated platform for managing quality in a regulated environment.
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01:24
Why can't one use Excel or Pen & Paper to manage quality at a FDA regulated company
Natalie explains the inadequacy of using traditional methods like Excel or pen and paper for managing quality in an FDA-regulated company. She highlights the limitations of these methods in ensuring compliance, tracking changes, and maintaining data integrity. Natalie emphasizes the need for a more robust and specialized system like Unifize, which can handle the complexities and requirements of FDA regulations more effectively.
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00:47
What would happen if Unifize was taken away from Natalie
In this video, Natalie shares her thoughts on the impact of potentially losing access to Unifize. She describes how integral the platform is to her daily operations and the significant setbacks that would occur without it. Natalie underscores the platform's role in streamlining processes, ensuring compliance, and facilitating effective communication, emphasizing its indispensability in her work routine.
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01:21
Why can't Slack replace a collaborative eQMS
Natalie addresses why communication platforms like Slack cannot replace a collaborative eQMS like Unifize. She points out the challenges and errors that would arise from relying solely on informal communication channels for quality management. Natalie stresses the importance of a dedicated eQMS for proper documentation, tracking, and compliance, highlighting Unifize's capabilities in meeting these specialized needs effectively.
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04:11
Who is Natalie and what is her role at Adaptive Health
Natalie introduces herself and her role at Adaptive Health in this video. She describes her responsibilities in overseeing the quality assurance and compliance aspects of product development. Natalie explains how her role is integral to maintaining the highest standards of product safety and efficacy, and she highlights the importance of leveraging tools like Unifize for effective quality management in a complex and regulated industry.
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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.
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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.
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01:28
Importance of collaboration between Product Development and Quality
Natalie emphasizes the crucial importance of collaboration between product development and quality teams in this insightful video. She discusses how Unifize has facilitated this collaboration, particularly in the ingredient review process and creation of master formulas. Natalie highlights how Unifize has brought about greater accountability, compliance, and efficiency in ensuring that the desired product formulations are accurately created and maintained.
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01:13
Bringing accountability and compliance into the system with Unifize
In this video, Natalie discusses how Unifize has brought enhanced accountability and compliance into their system. She emphasizes the platform's role in ensuring that every change and process is properly documented and visible, which is critical for maintaining compliance. Natalie also highlights how Unifize's collaborative features enable better communication and task management, streamlining processes and preventing errors, thereby significantly improving operational efficiency and compliance adherence.
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