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.
Transcript
Related Videos
Unifize Results
10x
Speed to compliance
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
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
01:13
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.
03:23
About Denis Machoka and his role as VP of Quality at Harmonic Bionics
Denis Machoka, VP Quality at Harmonic Bionics, shares his evolution from a scientist with a background in chemistry and biology to a Quality Systems expert. He delves into his experiences in laboratories, IT systems implementation, and his expertise in qualifying systems within regulatory frameworks.
01:42
Why is Carol using Unifize now
In this video, Carol Wilson from Efco shares her transformative experience with Unifize, highlighting how it revolutionized their document management process. Facing a daunting challenge of retrieving ten-year-old certification documents for a government audit, Carol discusses the inefficiency of their previous system, where critical documents were buried in emails or physical files, leading to weeks of searching by multiple team members. She outlines how Unifize streamlined this process, allowing for easy access to documents through purchase orders, significantly reducing search time and improving efficiency for the entire team.
01:54
About Efco and their products
Dave Anderson provides an overview of Efco's operations, focusing on their specialization in steel forming equipment for concrete construction projects, from stadiums to bridges. Efco, headquartered in Des Moines, Iowa, with a manufacturing presence in Georgetown, Canada, and strategic locations worldwide, serves the global construction industry. The company has transitioned from coiled to sheet steel, employing advanced manufacturing technologies. Dave highlights Efco's role in major projects, such as the Las Vegas Sphere and Dallas Cowboys Stadium, underscoring its significance in the construction sector.
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.
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.
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.
01:52
Avoiding the mistake of thinking you need a complex QMS software to scale
Denis Machoka addresses misconceptions in QMS, emphasizing the value of easily accessible information for compliance. He challenges the notion that larger, more complex systems are inherently better, suggesting that simplicity and efficiency should be the focus.
01:52
How Unifize helps save time and get things done faster
In this video, Michael from Harmonic Bionics celebrates the transparency and coherence Unifize offers. He values the platform's ability to keep everyone synchronized, viewing the same documents and chat histories. This clear and shared understanding of processes, from part designs to quality notifications, not only fosters efficiency but also lets Michael concentrate more on his primary responsibilities, enhancing productivity.
00:45
Fostering a culture of continuous improvement with Unifize
Mikala shares her experiences in fostering a culture of continuous improvement at her organization using Unifize. She details how the platform has been instrumental in promoting collaboration, streamlining processes, and encouraging proactive problem-solving. Mikala underscores the importance of Unifize in facilitating a more dynamic and responsive approach to quality management, which has been pivotal in driving continuous improvement and operational excellence.
01:08
Problems with managing quality using Excel and Word
The video outlines the inefficiencies and limitations encountered when managing quality systems through traditional tools like Excel and Word. The speaker describes the struggle with document control, lack of true automation, and the inability to effectively implement reminders or systematize processes for quality management. This approach proved unwieldy, manual-intensive, and required significant personnel oversight, posing challenges for a small company with limited quality assurance resources. The transition to Unifize is depicted as a crucial move to alleviate these burdens and enhance the quality management process.
00:58
Does Efco comply to any external standards
Dave Anderson discusses Efco's approach to compliance standards, emphasizing that while not formally ISO certified, Efco's processes mirror ISO principles of record-keeping and operational consistency ("say what you do, do what you say"). He highlights Efco's adherence to ASTM standards for manufacturing, from threaded products to welding, and the training of welders to AWS standards. This ensures a high level of quality and readiness for certification, despite not having pursued formal ISO certification due to not yet seeing the need for it.
03:51
How Unifize helped reduce $60,000 of material cost on just one product
Jesse Kolstad shares a transformative experience at Biovation Labs, emphasizing the power of perspective. With Unifize, he could holistically evaluate their ingredient performance and volumes, enabling him to whittle down from 16 SKUs to just two. This consolidation not only simplified management but also resulted in substantial cost savings for the company.
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.
02:32
How Unifize's no-code configuration speeds up implementation
Clarissa Archer emphasizes the significance of adaptability in Harmonic Bionics' choice of a QMS. With Unifize, they could shape the software to their specific needs, bypassing the rigidity of traditional systems. The power to make direct adjustments without relying on external teams was a game-changer for them, speeding up processes significantly.
02:28
Evaluating other eQMS software tools
Denis Machoka delves into the evaluation process of various eQMS tools, citing considerations for present needs and future growth. Comparing Unifize to platforms like Ignite EDMS, Veeva, and Greenlight Guru, he underscores Unifize's ease of implementation and its integrated conversation feature as standout advantages.
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.
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.
02:35
How Unifize made me a hero in my company
Jesse Kolstad shares how Unifize has amplified his impact and recognition at Biovation Labs. The platform's transformative capabilities have led to substantial operational enhancements, making its users, like Jesse, pivotal contributors to the company's success.
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.
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
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.
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.
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.
