What are the quality standards followed at Applechem
This video outlines the stringent quality standards Applechem adheres to in its product development process. Emphasizing compliance with global regulatory requirements and a commitment to safety and efficacy, it showcases the company's dedication to maintaining high-quality benchmarks in the cosmetics industry.
Transcript

00:00 - 00:09
As a manufacturer of ingredients for cosmetics, we of course have to comply with the FDA, CFR 21, you know, the Food and Drug and Cosmetics Act.



00:09 - 00:20
But there's also in order to give customers the confidence that what we're making is of high is, is high quality product. We need to make sure that we're adhearing to the good manufacturing processes as well.



00:20 - 00:31
Part of that process involves making sure the quality management system is is standardized and in place and is able to be recognized by external customers.



00:31 - 00:38
And that's why you also have to follow ISO 9001:2015 QMS requirements too.



00:38 - 00:56
Between the ISO 9001, the ICH Q7, CGMP Standards for quality for active pharmaceutical ingredients, we have a lot of different regulatory and quality standards that we have to be in compliance with to to manufacture our products.



00:56 - 01:03
The most difficult one by a long shot. And it's not unexpected is ICH Q7, CGMP.



01:03 - 01:13
Whenever you're involved with the manufacturing of active pharmaceutical ingredients in the United States, zinc oxide and titanium dioxide are considered active pharmaceutical ingredients.



01:14 - 01:18
And so we have to follow a higher standard than most cosmetic companies as it is.



01:18 - 01:24
That's always been the challenge because this is the same standard used by pharmaceutical companies.



01:24 - 01:36
So, it's about weighing the requirements that are more designed for drug manufacturers being used internally versus a topical sunscreen.



01:36 - 01:39
The scope of requirements increases a great deal.



01:39 - 01:47
Whereas before you're in the standard ISO 9001 quality management system, you're worried about just documentation of calibration for your instruments.



01:47 - 02:05
Well, now you need to be able to not just validate but show documentation of your validation, extensive validation through standard IQ, OQ, PQ type of process qualifications, which is extremely resource intensive process, but it's something that's absolutely required to be compliant with CGMP.



02:05 - 02:18
You have stability testing requirements a long term stability as well that needs to be consistently validated over and over and over again to ensure that the drug that's being outputted is of a consistent quality as well.



02:18 - 02:34
That's also very resource intensive. There's a lot of long term testing and stability controls that need to be put in place that most smaller cosmetic manufacturers aren't necessarily equipped to deal with, that pharmaceutical companies are just used to doing all the time.



02:34 - 02:44
And so the resources, the equipment, the capital expense required to be able to have those systems put into place and work effectively in your facility is significantly higher.

Related Videos

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

02:48
What are the quality standards followed at Applechem
This video outlines the stringent quality standards Applechem adheres to in its product development process. Emphasizing compliance with global regulatory requirements and a commitment to safety and efficacy, it showcases the company's dedication to maintaining high-quality benchmarks in the cosmetics industry.
Watch Video
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.
Watch Video
02:14
Time saved in streamlining communicaton
In this video, Seth Bozman delves into the significant time savings and efficiency gains Efco experienced by transitioning to Unifize. He vividly illustrates the cumbersome nature of their previous system for handling quality control documents and how Unifize simplified these processes. Seth’s narrative underscores the direct impact on productivity, from reducing the time it takes to write and manage remake cards to enhancing collaboration across departments. This transformation allowed Efco to not only save time but also improve accuracy and accountability in their operations.
Watch Video
01:23
Quantifying things that were previously deemed impossible
In this video, Seth Bozman from Efco shares his transformative experience with Unifize, emphasizing its critical role in revolutionizing how they track and manage work orders, particularly in quantifying costs of specials and parts in a manner previously unachievable. He highlights Unifize's impact on making their process more efficient, allowing for a significant increase in productivity by enabling a more precise cost analysis and facilitating an enhanced focus on floor operations. Seth's testimony showcases the power of Unifize in streamlining operations, improving data accuracy, and supporting proactive decision-making at Efco.
Watch Video
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.
Watch Video
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.
Watch Video
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.
Watch Video
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.
Watch Video
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.
Watch Video
01:08
Moving away from CCPs to Preventative Controls with Unifize
Highlighting the shift to preventative controls, Jesse Kolstad values Unifize's visibility and supplier management. Unifize seamlessly aligns with food safety, optimizing supplier evaluations and quality control at Biovation Labs.
Watch Video
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.
Watch Video
05:38
How Unifize helped build our processes efficiently from scratch
In this video, Jesse Kolstad of Biovation Labs contrasts his experience with MasterControl's structured modules to the flexibility offered by Unifize. Reflecting on the early stages of his career, Jesse appreciated the structured guidance, but as his expertise grew, he found immense value in the "blank canvas" approach of Unifize, allowing for tailored and efficient process development.
Watch Video
03:46
Comparing Unifize to other eQMS software
Clarissa Archer narrates Harmonic Bionics' journey in searching for an optimal QMS. Evaluating various systems, they prioritized features like change control, product lifecycle management, and electronic signature compliance. While they considered prominent systems like Master Control, ETQ, and Greenlight Guru, their quest for seamless collaboration was paramount.
Watch Video
05:44
How Unifize helps quality leaders take better decisions on Out of Specs
Jesse Kolstad revisits a challenging situation from his early days at Biovation Labs — a significant backlog of Out of Specifications (OOS) cases. Determined to enhance the OOS process, Jesse embarked on a deep dive into the existing procedures and systems. He emphasizes the value of having a clear understanding and the ability to trend data, showcasing Unifize's instrumental role in bringing clarity and improved decision-making.
Watch Video
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.
Watch Video
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.
Watch Video
01:49
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.
Watch Video
01:35
The simplicity of the Unifize onboarding process
Denis Machoka praises the effortless onboarding process with Unifize. Pre-established access matrices ensured a smooth transition. He lauds the platform's ease of setup, where users quickly received access links on their devices, and emphasizes the consistent user experience across multiple platforms, highlighting its adaptability.
Watch Video
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.
Watch Video
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.
Watch Video

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.