Overview
Wilson Lin, the visionary behind Applechem, shares his transformative experience with Unifize, highlighting how the platform has redefined their approach to compliance, documentation, and operational efficiency amidst the stringent regulatory landscape of the cosmetics ingredients industry.
Challenge
Wilson faced significant hurdles in managing documentation, ensuring regulatory compliance, and facilitating effective communication within Applechem. The traditional systems in place were not only resource-intensive but also hindered the company's ability to innovate and respond dynamically to market demands.
Solution
After exploring various quality management systems, Applechem adopted Unifize for its unparalleled flexibility, user-centric design, and comprehensive compliance functionalities. Unifize's ability to seamlessly integrate electronic signatures and manage complex documentation requirements stood out, offering a tailored solution that aligned with Applechem's unique needs.
Ease of Use
The intuitive interface of Unifize allowed Wilson and his team to customize the platform to their operational workflows, significantly streamlining the management of critical documentation without disrupting their established processes.
Communication and Collaboration
Unifize revolutionized internal communication at Applechem, centralizing discussions, feedback, and decision-making processes. This consolidation eliminated the dependency on inefficient communication channels, ensuring that crucial information was always accessible and actionable.
Documentation and Compliance
With Unifize, Applechem achieved a new level of documentation integrity and compliance readiness. The platform's robust audit trail capabilities and document control features enabled the team to maintain comprehensive records, simplifying audit preparations and regulatory submissions.
Results
Implementing Unifize led to dramatic improvements in Applechem's operational efficiency, reducing the time spent on managing change requests and documentation from weeks to days. This acceleration did not compromise compliance, instead fostering an environment where innovation could thrive alongside strict regulatory adherence.
Professional Preparedness
The detailed and organized record-keeping facilitated by Unifize empowered Wilson and his team to confidently address regulatory inquiries, ensuring that Applechem remained ahead of compliance challenges and audit requirements.
Regulatory Alignment
Unifize's comprehensive feature set supported Applechem's adherence not only to FDA regulations but also to international standards and guidelines, reinforcing its commitment to quality and safety in the cosmetics ingredients sector.
Conclusion
For Applechem, Unifize has become an indispensable ally, enabling the company to navigate the complexities of regulatory compliance with ease, enhance operational efficiencies, and ensure that every team member remains informed and aligned. Wilson's experience underscores the potential of Unifize to transform quality management and compliance processes, proving that innovation and regulatory compliance can indeed coexist harmoniously.
Unifize itself is not a solution to having bad processes. But if you have good processes in place, but the way you execute those processes is too resource intensive, and you're having issues with keeping everyone on the same page, a platform like Unifize can solve a lot of those issues.
[00:18 - 00:32]
People hate to admit it, of course, but, you know, sometimes you just don't pay attention to it until you know that an auditor is coming in. But then if you're going to wait till that point, then you're not running a quality management system the way it was originally intended.
[00:32 - 00:46]
So, you know, being able to use Unifize and saying that we are trying to reduce the friction between documentation and compliance with what is actually going on your work day, every single day.
[00:46 - 00:48]
That's the option that Unifize opens up to us.
[00:48 - 00:55]
I'd say it's mainly a big quality of life improvement in how that process works.
[00:55 - 00:59]
Unifize ended up being the right choice for us. I would absolutely recommend it.
[01:04 - 01:19]
My name is Wilson Lin, I wear many different hats here at Applechem. I've been with the company for almost 18 years now, and so I handle marketing, regulatory, compliance as well as managing the quality assurance department here, here at the company.
[01:19 - 01:30]
So Applechem is a research and development technology company that creates and manufactures functional ingredients for the personal care and cosmetics space.
[01:30 - 01:40]
So we are in charge of making, you know, the thickeners, rheology modifiers, pigment dispersants, the stuff that makes the formulations tick inside of the consumer products that people enjoy every day.
[01:40 - 01:52]
Applechem has 18 employees right now. We're located in Parsipanny, New Jersey. Our facility here is designed for foreign office administration, R&D activities, as well as manufacturing and warehousing.
[01:52 - 02:06]
We've got customers all over the place, so anywhere from small indie brands starting out with the Nuon skincare or Suncare lines all the way to the larger multinationals like Estee Lauder and Chanel.
[02:06 - 02:15]
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.
[02:15 - 02:26]
But there's also in order to give customers the confidence that what we're making is of high quality product. We need to make sure that we're adhering to the good manufacturing processes as well.
[02:26 - 02:44]
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 manufacture our products.
[02:48 - 03:23]
We weren't leveraging our quality management system to its fullest potential to help improve how we do our day to day business operations. And that's the whole point of having a quality management system in the first place is to be able to identify, control, document, and then create improvements in how those core business practices affect the quality output of your product, how that entire system works, and if the mechanics of how that quality management system operate are so difficult to work with in the first place, or so resource intensive, then it becomes a self-defeating prophecy.
[03:23 - 03:32]
Unifize from what I was reading was designed to solve that. I don't think businesses can be competitive when departments are working in data silos.
[03:32 - 03:39]
I think in the modern world now, especially as companies grow larger and they are more being merged with other companies.
[03:39 - 03:54]
And so the ability to transfer information back and forth and have everyone in different parts of the world looking at the exact same info at a single source of truth becomes more and more important for collaboration to work effectively in the modern world.
[03:54 - 04:21]
Collaboration for me now is the ability for all stakeholders involved in the development of a business or operation of a business process to be looking at a single source of truth so that any conversations, any data input or updates, all that is going to a centralized place. And there's no inefficiencies involved in keeping everyone talking about the same things with the same framework, with the same context.
[04:24 - 04:28]
The biggest improvements are around visibility and accountability for us.
[04:28 - 04:42]
We didn't have to ask if a certain document had been sent out to a supplier or if it had been sent back and filled out correctly. We didn't have to ask if certain coding documentation was already in place before we moved to another stage in the validation process.
[04:42 - 04:51]
We can see that it's already been done and so those questions, those conversations didn't need to happen again. It didn't need to happen in the first place.
[04:51 - 05:11]
Just being a central repository for all these discussions in line with a checklist of all the necessary stages, all the necessary documents, all the necessary tasks required for launching a new product makes it a lot easier to keep everyone together and talking. And this has also reduced the amount of time spent on meetings.
[05:11 - 05:23]
Every meeting, subsequent meeting is reiterating the same information all the way up to the managing director. And at that point you spent how many hours talking about the exact same thing and there's no resolution in sight.
[05:23 - 05:36]
So being able to eliminate 90% of that discussion and go straight to having all that information in a single place with the ability to enter all the information into the process on Unifize so that everyone can see it at the exact same time.
[05:36 - 05:42]
That level of transparency has been invaluable to us. It's a very much a quality of life improvement.
[05:42 - 05:49]
You know, we're glad that we were able to find a system like Unifize because it takes a huge burden off the active management part.
More from Wilson Lin
Unifize Results
Speed to compliance
Faster time-to-market
Fewer meetings