How Unifize speeds up change control
Jesse Kolstad emphasizes Unifize's prowess in managing change, navigating the challenges of either over-documentation or under-documentation in some companies. With features like versioning, Unifize ensures comprehensive tracking, offering unparalleled visibility and accountability in change management at Biovation Labs.
Transcript

[00:00 - 00:23]
Unifize has been incredibly powerful for me to manage change because truthfully, management of change is a very hard process because and in my experience it goes one of two ways. People want to document every change. I remember one company, they wanted to do a whole management of change meeting about switching toilet paper suppliers, and that was just ridiculous.



[00:23 - 00:38]
But that's one end where they go too far. And then there are those who make changes and then you don't know when or where or how or who or what. And so Unifize has through its versioning. That's one huge tool I can take. Let's take an ingredient spec for example. And I say, You know what, the spec wasn't right.



[00:38 - 00:51]
I can do a revision and it takes all the existing data, transpose it to version two, and then I have a time date a aware of who and approval. And that's so effortless relative to what management change used to be.



[00:51 - 01:17]
Historically and at other companies and even here when I started change management was emails, questions, requests, a lot of back and forth. So first and foremost, by putting it in the chat, I've cut the time dramatically. I've cut the visibility of, increase the visibility dramatically and the effectiveness of the management of change process. Again, it just like everything else, starts to gain its own life because people see how easy it is and after they do one, then they're like, You know what?



[01:17 - 01:31]
I have some other ideas, and it actually becomes rather than doing a management of change process because you have to, it allows us to use it for what I believe management of change regulations and guidelines were meant for, and that's continuous improvement.

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

00:24
Unifize - a validated QMS software
Denis Machoka elaborates on the validation credentials of Unifize as a QMS software. He underscores that Unifize is pre-validated, comes with a comprehensive validation package, and emphasizes the simplicity of its configuration, stressing the need for proper documentation.
02:36
Reducing redundancies and getting things done faster with Unifize
In this video, Wilson highlights how Unifize has transformed their approach to product quality and development processes. By integrating Unifize early in the R&D phase, they've significantly enhanced discussions around quality, compliance, and consumer trends. This centralization has streamlined workflows, reduced the need for excessive meetings, and facilitated better communication across departments. The platform's ability to serve as a single repository for all relevant information has led to a notable improvement in efficiency and quality of life for the team, demonstrating Unifize's impact on eliminating redundancies and speeding up project completion.
01:26
Making compliance a part of everyday workflow with Unifize
Wilson discusses how Unifize has seamlessly integrated compliance into daily workflows, transforming it from a cumbersome obligation to an effortless aspect of routine operations. This change has led to improved adherence to standards and regulations, with the speaker emphasizing the platform's role in making compliance natural and manageable.
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.
01:19
My role and prior MedTech QMS experience
Clarissa Archer, a Quality Assurance Engineer at Harmonic Bionics, shares her decade-long journey in the medical device industry. Beginning in product development, she transitioned to quality assurance, drawn by her passion for risk analysis and compliance. With a biomedical engineering background from Texas A&M, she emphasizes the importance of hands-on experience in understanding regulations in the medical device space.
01:39
Future of Unifize in Efco
Dave Anderson explores the exciting prospects of Unifize within Efco in this forward-looking video. He discusses the evolution of quality management processes facilitated by Unifize, highlighting the platform's ability to enable trend spotting and proactive responses to various challenges. Dave shares insights on integrating Unifize across different company operations, including warranty claims and quality records management, and addresses the ongoing transition from paper-based to digital systems. This journey with Unifize not only aims to enhance operational efficiency but also to lay the groundwork for future innovations in managing company workflows.
02:54
Corrective actions and risk assessment with Unifize
This video showcases how Unifize streamlines corrective actions and risk assessments, enabling more efficient problem resolution and risk management. The speaker emphasizes the platform's role in promoting a proactive approach to identifying, assessing, and mitigating risks, thereby improving overall safety and compliance.
01:36
Managing Incoming Material and Lot Tracking on Unifize
In this video, Clarissa discusses the challenges and solutions for managing incoming materials and lot tracking using Unifize. They emphasize the difficulties faced in quality assurance, especially when parts or products do not meet inspection standards. The video illustrates how Unifize streamlines this process by enabling easy tracking of lots, keeping essential documents like certificates of conformance and material certificates organized. The speaker highlights the convenience of having all relevant information, such as lot numbers and PO numbers, scanned and stored in Unifize, facilitating efficient tracking and inspection. They conclude by praising Unifize's collaborative features, which significantly enhanced their team's engagement with the new Quality Management System (QMS).
02:38
How Unifize makes audits easier
Jesse Kolstad highlights the revolutionary change Unifize brought to Biovation Labs' internal audit process. The platform facilitates direct capture and storage of visual evidence like photos, ensuring context and clarity. Drawing a contrast with past practices of manual note-taking and subsequent transcription, Jesse appreciates Unifize's real-time documentation that eliminates back-and-forth and enhances audit efficiency.
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.
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.
07:00
How Unifize's real time collaboration empowers faster and efficient decision making
In this video, Jesse Kolstad of Biovation Labs accentuates the power of Unifize's real-time collaborative environment. He praises its capability to manage multiple tasks concurrently, leading to significant time savings, increased visibility, and enhanced communication. Jesse emphasizes how this real-time collaboration facilitates swift and effective decision-making.
02:33
Getting engineering to adopt a new eQMS
Clarissa Archer reflects on Harmonic Bionics' transition from a research-centric organization to one focused on compliance. She reminisces about the sudden surge in documentation and the challenges it presented to engineers and product developers. Accustomed to flexible laboratory environments, the team had to adapt to the structured, documentation-heavy world of compliance, making the choice of a user-friendly system like Unifize crucial.
00:38
About Seth and his role at Efco
Seth Bozman introduces himself and his role at Efco, detailing the company’s operations and his responsibilities in managing scrap and rework. He discusses the transition from traditional methods to utilizing Unifize, highlighting the platform's impact on improving data analytics, reporting, and operational efficiency. This video provides a personal insight into Seth's professional journey and the transformative effects of Unifize on his work at Efco.
01:42
About Dave
In this video, Dave Anderson, Quality Assurance Manager at Efco with 20 years of tenure, shares his journey from the shop floor to senior supervisory roles before stepping into quality assurance. With a passion for continuous improvement and an improvement-minded approach, Dave emphasizes the importance of striving for perfection in quality management. His experience highlights the value of shop floor knowledge in identifying root causes and implementing sustainable solutions, underscoring the significant impact of hands-on experience in quality roles.
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.
01:47
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.
01:56
Handling artwork revisions with Unifize
In this video, Erica describes the artwork management process within her organization and how Unifize plays a crucial role in it. She begins by explaining that the artwork process doesn't start in Unifize but is incorporated once the artwork is approved. Unifize then becomes the repository for the final versions, ensuring that everyone accesses the correct and latest artwork for each product. Erica elaborates on the pre-Unifize procedure, including revisions and approvals from print suppliers. She uses Unifize to verify the currentness of documents, flagging any discrepancies, especially with revisions received from suppliers. This system prevents printing errors and ensures accuracy. Furthermore, Unifize's documentation feature allows Erica to trace back the history of revisions, understanding the reasons behind each change. This video highlights Unifize's effectiveness in managing and tracking artwork revisions, ensuring quality control and accuracy in the production process.
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.
03:10
Investigating deviations with Unifize
The video explains Unifize's approach to managing deviations, emphasizing the platform's effectiveness in identifying, analyzing, and resolving discrepancies swiftly. It highlights how Unifize facilitates a comprehensive investigation process, contributing to higher standards of quality and compliance.

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.