Building a knowledge base in a startup with Unifize
Michael delves into the distinctive aspects of working in a compact company setting. He underscores the pivotal role of relationships, whether with colleagues, suppliers, or clients. Highlighting the importance of human-centric approaches in startups, Michael contrasts this with the rigidity and compartmentalization of vast corporations. His reflections shed light on the balance between the personal touch and systematic workflows in different company sizes.
Transcript

00:00 - 00:14
The thing about working at a small company is that it's the you know, it's about relationships, both with your coworkers, but with your suppliers, with your customers.



00:14 - 00:40
Right. When you have your people, the importance of people over systems becomes much more important. There's always there's always that balance, right? You can work for these huge 80,000, 80,000 person companies like Raytheon, where you have a very clearly defined role. It's very rigidly boxed. You only know the information for your particular project that you need to know.



00:40 - 01:07
I mean, literally your design inputs don't tell you anything about what you're actually working on in some cases for for good reasons. At a startup, it is it is very much about, you know, what is my what is my working relationship with my quality engineer, what is my working relationship with my suppliers? Right. Because at the end of the day, for a small company they live and die on, on relationships.



01:07 - 01:44
As far as the that ties into compliance, I mean, the thing is that everybody has to hold everybody accountable, right? We don't have the overhead or the or the systems that accrue over time that a rigidly enforce a set of standards as determined by the company. Right. And, you know, regulations are written from, at least in my opinion, from the sense that if you're doing everything right, everything that you should be doing, if you're doing a good job, you know, you will be very close.



01:44 - 02:07
If not already compliant with most standards. There was very few gotchas I've seen there in a tripped up. But the key thing is, is that you need to communicate right? I don't have a walking corpus of, you know, ISO 60601 in my head, right? I can't know everything about it, but between all the people at this company we do.



02:07 - 02:32
And so being able to communicate clearly with each other and being able to have information in a way that's easily accessible, that is flexible processes, is it is the strategy that you need to maintain, Right? If you try to enforce a rigid system on a start, it's just not going to work. There's no way, right?



02:32 - 02:40
You you know, there are days where I'll put on more of a quality engineering hat and maybe I'll go audit suppliers.



02:40 - 03:17
There are days where, you know, in the old days I'd literally was building robots in back. I was the technician. So I think that, you know, tying it back to regulation and I guess to Unifize is that the system that we have with Unifize reflects the scale and size of our company and the fact that it's so adaptive and we've changed it several times over already as we've learned more how to use the system and as we grow as the company is, that's really, you know, what we need as a company

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

01:07
How did you discover Unifize
Dave Anderson shares the journey of discovering Unifize through a diligent search for a quality management system that could transition Efco from traditional, paper-based processes to a more efficient, cloud-based solution. Starting with Google, they came across Software Advice, which recommended several QMS options, including Unifize and QT9. Dave highlights the clunky and outdated methods of record-keeping they wanted to move away from, leading them to prioritize cloud-based solutions. Ultimately, the choice was made for Unifize, largely due to its superior collaboration features over the competition.
03:00
Connecting the dots- managing a DMR & DHF on Unifize
Denis Machoka emphasizes Unifize's prowess in managing DHF and DMR data, highlighting the platform's traceability, accessibility, and real-time status updates. He appreciates its ability to keep users informed about the latest file versions, preventing potential confusions. Denis also touches upon his AI background and experience with IBM.
01:10
Reducing lot release time down to minutes with Unifize
Jesse Kolstad highlights how Unifize has dramatically curtailed lot release times at Biovation Labs. By optimizing the process, Unifize ensures lot releases are executed efficiently, reducing times to mere minutes.
01:24
Why Unifize’s unique approach to collaboration helped Harmonic Bionics
Denis Machoka discusses the unparalleled collaborative approach of Unifize, highlighting its ability to centralize and streamline conversations, reducing the traditional reliance on emails. He praises its efficiency in consolidating information and contrasts it with the inefficiencies of managing multiple systems in other platforms.
01:02
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.
03:06
Raw material validation with Unifize
The video delves into how Unifize streamlines the raw material validation process, enhancing efficiency and ensuring compliance. It highlights the platform's role in simplifying complex validation procedures, thereby facilitating a more robust quality control framework.
01:47
The problems Tedd faced with managing multiple quality systems
Mired in an archaic quality system since 1994, The Will-Burt Company grappled with a maze of spreadsheets and disjointed programs until Unifize revolutionized their process. Tedd Carr shares how their transition to Unifize's singular platform dissolved the cumbersome task of correlating data across five different systems, unveiling trends and accelerating efficiency in quality management.
01:36
Closing the loop- Traceability and lot tracking using Unifize
Denis Machoka elucidates the intricate process of traceability and lot tracking at Harmonic Bionics, especially for their robotic devices. He details the meticulous tracing of parts, their consumption, and potential issues. Denis highlights how Unifize is instrumental in ensuring precise tracking and updating of materials consumed during the device development.
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.
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.
00:48
How Unifize links raw materials to lots, formulas and finished products
Jesse Kolstad highlights Unifize's capability to seamlessly link raw materials to lots, formulas, and finished products. Providing a comprehensive view of the production process, Unifize ensures unparalleled traceability and accountability, enhancing production oversight at Biovation Labs.
02:15
Three reasons why Unifize is the easiest QMS- Security, simplicity, compliance
Denis Machoka advocates for Unifize as a QMS, praising its exceptional ease of implementation and intuitive design. Drawing a comparison with other renowned systems, he emphasizes Unifize's simplicity and rapid setup, making it a standout choice in the realm of quality management syst
05:21
Why Biovation moved from MasterControl to Unifize
Jesse Kolstad reminisces about his journey with quality management systems, notably his pivotal role in deploying MasterControl. As he navigates through the landscape of electronic documentation circa 2016, he highlights the challenges presented by platforms like SharePoint. While acknowledging MasterControl's early advantages, Jesse candidly critiques its user interface, shedding light on why a transition to Unifize became essential for Biovation Labs.
01:08
Streamlining processes efficiently in a small company with Unifize
In this video, Wilson shares how Unifize revolutionized their small company by significantly enhancing visibility and accountability. Emphasizing it as a major quality of life improvement, they highlight the streamlined processes that now require less personnel involvement. The key efficiency gains were not in manpower reduction but in the quality of communication and process execution. Unifize eliminated the need for repetitive confirmations about document exchanges and validation steps, facilitating a smoother, more transparent workflow that benefitted product leaders, quality control, and their CTO.
01:25
Enhancing traceability and improving visibility and accountability with Unifize
This video showcases Unifize's capabilities in boosting traceability, visibility, and accountability within organizational processes. The speaker illustrates how the platform fosters a transparent environment where tasks and responsibilities are clear, enhancing overall operational efficiency.
05:04
Problems with managing quality at nutraceutical companies
Jesse Kolstad paints a vivid picture of the recurring challenges he's faced in the realm of quality management. From overloaded file cabinets to underutilized QMS systems, he's seen a pattern of data not being harnessed effectively. Jesse shares his thoughtful approach to quality enhancement, highlighting the importance of keen observation and understanding before diving into reforms, reflecting his depth of experience and commitment to excellence.
01:53
About Jesse Kolstad
Jesse Kolstad, the Director of Quality, Compliance, and Formulation at Biovation Labs, gives an intimate peek into his role and the company's operations. Located in Salt Lake City and part of the Wellful organization, Biovation Labs plays a pivotal role in manufacturing capsules and tablets. Jesse also highlights their collaboration with prominent industry giants, underscoring Biovation's significance in the dietary supplement sector.
05:02
How Applechem approaches product development and commercialization
Applechem's approach to product development and commercialization is detailed, showcasing their emphasis on rigorous research, customer collaboration, and market analysis. The process underscores a strategic method to ensure that new products are both innovative and aligned with market needs.
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.
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.

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.