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.
Transcript

00:00 - 00:09
In terms of data for DHF and DMR, Unifize does a great job in making that information accessible, simplified.



00:09 - 00:21
There's a lot of changes that happen in those files, and it's always good to see the history of that file, who accessed it when it was updated, what was updated, What is the latest file?



00:21 - 00:41
Unifize does a very good job of actually tracking all of those elements in your design views to file. So when you get that last file, you know that you're having the latest file and it's not stuck in some email or it's yet to be uploaded somewhere because even that system will show you the status of that file where it is at the present moment.



00:41 - 01:11
So it's really unique tool that allows you access unprecedented access, really, because that's really where we are in this age, where things are moving so fast and is a lot of things and decisions that need to be made on the fly really allows that to happen. Now, I come from artificial intelligence. I worked for IBM in the past, and so when you work with artificial intelligence, you're talking thousands of nodes being done, being connected.



01:11 - 01:16
At the same time, you're talking of the brain of the Internet. You can imagine how fast you have to process that.



01:16 - 01:30
We're not necessarily looking for that, but the ability to have that level of knowledge immediately is something that for organizations that are looking for nimble agility, this tool is definitely going to drive you there.



01:30 - 01:47
Compared to other systems that manage DHF and DMRs, Unifize brings a very unique addition to that process. One of the unique things is the relationship between the files. So when you have different files, you can tell the relationship between the files.



01:47 - 02:02
Some systems you may able to do that, but it's you have to do a little more digging. Not only do you have to do digging, but you also have to know where that file is. You have to dig into the file, see where the relationships are. There's a little more work that is involved.



02:02 - 02:19
When you look at Unifize, it simplifies that process because all the files are visible in objects and you're able to open each file and view what is within those files and associated discussions. That's where the most important part of the whole thing is.



02:19 - 02:37
Who added the file, what was added when it was added. So you have a little more history of context. At most other systems like MasterControl and the rest of the other systems, you may find that you may not have that information. You need to go to somebody who did the file, update to the file to give you the context of that information.



02:37 - 02:50
Unifize keeps that context. So if you're in an audit or you're being audited, for example, and you want to find out why that file changed the last few months, you have context because that information is still there.

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

04:27
Near instant implementation and adoption of Unifize
Jesse Kolstad lauds Unifize for its intuitive design and quick adoption. With tools that foster user engagement and autonomy, Unifize integrates smoothly into Biovation Labs' daily operations.
01:13
Reviewing documentation in half the time with Unifize
In this informative segment, Erica enthusiastically discusses how Unifize revolutionizes supplier audits and ingredient management. She delves into the platform's intuitive interface, allowing for easy document uploads and efficient tracking. Erica emphasizes the significant time-saving benefits, noting how Unifize cuts down task durations dramatically with its customized checklist feature. She illustrates the stark contrast between the traditional, time-consuming methods and Unifize's streamlined approach, concluding with praise for the platform's drag-and-drop functionality. This segment effectively highlights Unifize's transformative impact on simplifying and accelerating quality control processes.
02:10
Importance of Approvals
The video emphasizes the critical role of approvals in the operational workflow, showcasing how Unifize simplifies and speeds up the approval process. It highlights the platform's ability to streamline decision-making and ensure compliance, thereby enhancing overall efficiency and reducing time to market for new initiatives.
01:32
Using dashboards on Unifize to make Management Review Meetings Easier
Denis Machoka underscores the significance of Unifize's dashboards in streamlining management reviews. Highlighting the need for quick access to high-risk data points, he appreciates the platform's ability to present crucial insights on-demand. Denis contrasts Unifize's efficiency with the traditional, tedious method of manually collating data, emphasizing the time savings.
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.
01:00
Enabling effortless information flow across the board with Unifize
Seth Bozman explores the challenges of articulating needs and implementing changes within Efco's operational procedures before Unifize. He reflects on the iterative process of customization and adaptation with Unifize, emphasizing its role in fostering a more efficient, error-proof workflow. Seth's story illustrates Unifize's capacity to streamline communication and process flow, ensuring that operational changes are seamlessly integrated and accurately reflected across the board.
01:04
How the Unifize team helped build our customisations faster
In this engaging video, Erica offers a fresh perspective on Unifize's standout customer support. She praises the promptness of the team, often responding within an hour, sometimes even in 10 minutes, ensuring immediate assistance. Erica shares her initial experiences as a new user of Unifize, emphasizing the value of regular team meetings in her learning process. She is particularly impressed by the platform's ability to tailor features to specific needs, such as creating custom PDFs, and the team's proactive approach to fulfilling complex requests. Erica's account highlights Unifize's dedication to responsive and personalized support, making the user experience both seamless and adaptable.
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.
00:30
How to standardize institutional knowledge for enhancing clarity
Seth Bozman shares insights into how Unifize has played a crucial role in capturing and standardizing institutional knowledge at Efco. He highlights the challenge of relying on knowledge passed down through years of experience and how Unifize's structured approach to operational procedures has facilitated better decision-making. This video demonstrates Unifize's impact on preserving critical knowledge and ensuring it's accessible to all, thereby speeding up processes and enhancing efficiency.
00:34
How big is Applechem
Applechem's current size and plans for expansion are discussed, indicating the company's growth trajectory. With 18 employees and a facility of 18,000 square feet set to expand to 42,000 square feet, the video highlights Applechem's increasing capacity for R&D, manufacturing, and warehousing in response to business growth.
00:28
Resolving Out of Specs and getting the product to market faster with Unifize
In this detailed video, Mikala discusses how Unifize has streamlined the process of resolving out-of-specification (OOS) issues. She explains how the platform has reduced the time products are held in quarantine, from a month to mere hours, thereby preventing delays and backorders. Mikala highlights the cost savings and efficiency gains achieved through Unifize, showcasing its significant role in getting products to market faster while maintaining quality standards.
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.
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.
01:08
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.
01:08
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.
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.
01:55
How Unifize improved our Non-conformances closure time by 75% within the first month
Within just a month of deploying Unifize, The Will-Burt Company slashed non-conformances closure times by an impressive 75%, as Tedd Carr attests. Previously languishing non-conformances averaging 4 to 5 weeks for resolution are now dealt with in a mere 7.2 days. This remarkable improvement in efficiency extends to customer complaints as well, with closure times cut by 60%, signaling a swift and responsive quality management system that's set to evolve further.
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 can't one use Excel or Pen & Paper to manage quality at a FDA regulated company
Natalie explains the inadequacy of using traditional methods like Excel or pen and paper for managing quality in an FDA-regulated company. She highlights the limitations of these methods in ensuring compliance, tracking changes, and maintaining data integrity. Natalie emphasizes the need for a more robust and specialized system like Unifize, which can handle the complexities and requirements of FDA regulations more effectively.
00:44
Under 24h response times from Unifize Customer Support
Dave Anderson praises the exceptional customer support of Unifize in this video, emphasizing the prompt and efficient response times to queries and issues. He shares his positive experiences, highlighting how Unifize’s support team consistently delivers solutions within hours, not days, ensuring minimal disruption to workflow. Dave's testimonial underlines the crucial role of Unifize’s customer service in enhancing operational efficiency and problem resolution, making it a valuable asset to any organization seeking to improve its process management.

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.