Dealing with non-conformances made simple with Unifize
In this video, Erica recounts a specific incident where a wrong revision of artwork was used, demonstrating how she utilized Unifize to manage the situation effectively. She was tasked with investigating the error, which involved gathering information and creating a non-conformance report in Unifize. Erica describes the ease of initiating this process in Unifize, starting from the affected finished good lot. She mentions that the error was traced back to their supply team and emphasizes the importance of thorough documentation in Unifize for tracking such incidents. Additionally, she highlights Unifize's capability to link specific incidents to affected products and its utility in generating reports. This allows for an efficient overview of non-conformances related to finished goods. Erica's experience showcases how Unifize streamlines the process of handling, documenting, and analyzing quality issues, enhancing organizational efficiency and accountability.

00:00 - 00:08
So if something takes place, Like, for example, there was a situation where a wrong revision was utilized for our artwork we had one revision that was current and another revision was used.

00:08 - 00:16
So we had to find out what happened, what caused this. I was responsible for contacting the person to find out.

00:16 - 00:23
Just gather all the information in terms of what actually what happened and creating the non conformance in Unifize is very simple just, just making sure everything is documented.

00:28 - 00:33
I initiated it in Unifize from the finished good lot and then because it wasn't necessarily something that was our responsible we didn't do it the the other our contract manufacturers someone from their team had to actually complete everything.

00:44 - 00:49
Yes. They had to do their on their part. They had to do the investigation and that.

00:49 - 00:52
So it was found out it was, it was an error from our supply team.

00:52 - 00:59
With Unifize, just making sure everything is documented, that that's one of the main things and then finding out what was affected.

00:59 - 01:05
So there was a particular finish good lot that was affected so we linked the finished good lot to that as well.

01:05 - 01:12
Say, for example, we wanted to write a report to see how many non-conformances that we had on our finished good lot, we simply run that report and do that And look that up.

Unifize Results

Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs

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

How to effectively utilize Unifize
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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.
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.
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.
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.
Comparing Unifize to other eQMS software
Clarissa Archer narrates Harmonic Bionics' journey in searching for an optimal QMS. Evaluating various systems, they prioritized features like change control, product lifecycle management, and electronic signature compliance. While they considered prominent systems like Master Control, ETQ, and Greenlight Guru, their quest for seamless collaboration was paramount.
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.
What happens when QA people develop software
This video offers insights into the unique perspective brought to software development by quality assurance professionals. It suggests that a focus on collaboration and flexibility, typically lacking in traditional QMS software, is essential for creating a system that truly meets the needs of all users. The speaker reflects on the importance of designing quality management tools that are not only about data storage but also about enhancing the user experience and operational efficiency.
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.
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.
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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.
Managing part revisions on Unifize
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Moving records from paper to the cloud
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Getting 100% buy-in from everybody
In this compelling video, Dave Anderson delves into the crucial aspect of achieving universal buy-in within an organization for Unifize. He outlines the challenges and strategies involved in garnering complete commitment from every team member, emphasizing the importance of direct involvement and accountability. Through personal insights and experiences, Dave illustrates how Unifize's approach eliminates sidelines, ensuring that every stakeholder is actively engaged in addressing issues, leading to more cohesive and efficient problem-solving processes.
How big is Applechem
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Handling resolutions for repeating issues
Dave Anderson discusses Unifize's resolution process, a critical component tied to the discussion board and quality action ticket system. This process addresses repetitive issues by allowing team members to refer to past resolutions, enabling off-shifts to act without waiting for engineer approvals. By documenting how problems were previously resolved, Unifize empowers supervisors with decision-making support and reduces the need for certain positions, such as the quality auditor on second shift. This growing library of resolutions enhances efficiency and problem-solving capabilities across shifts.
Moving from MasterControl to Unifize
In this insightful video, Erica reflects on her transition from using MasterControl to adopting Unifize for quality management. She shares her journey of growth and adaptation with Unifize, highlighting its superior efficiency in document handling and management. Erica notes the stark contrast between the two systems, pointing out how Unifize simplifies document uploads and centralizes management with just a click. She also touches on the benefits of Unifize's collaborative capabilities, allowing seamless integration with external partners like contract manufacturers. Erica's narrative emphasizes Unifize's user-friendly interface and its effectiveness in streamlining quality control processes, which were previously cumbersome with traditional methods like email or Dropbox.
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What drove Wilson towards Unifize
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The core problem Seth was facing at Efco
Seth Bozman discusses the pivotal challenges he faced at Efco before integrating Unifize into their workflow. Central to his testimony is the struggle with tracking and managing information, particularly the return of documents and data from the shop floor. Seth outlines how the Unifize platform provided a solution that streamlined communication, ensured document return, and enhanced overall efficiency. This video offers a candid look at the transformative effect of Unifize on Efco's operations, spotlighting the importance of digital solutions in modern manufacturing environments.

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
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Here’s how Biovation Labs reduced testing costs from $146K to $65K in two months

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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.

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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.