What made us switch from MasterControl to Unifize
In this comprehensive narrative, Mikala explores the decisive factors that led to the switch from MasterControl to Unifize. She discusses the limitations and challenges she faced with MasterControl, including its inefficiency and user-unfriendliness. Mikala then delves into the aspects of Unifize that prompted the change, such as its innovative approach, user-centric design, and efficiency, which have significantly improved their operational processes and overall workflow management.
Transcript

00:00 - 00:10
The only one we looked at was MasterControl and we were on board with them for about two years. And that was all it took for us to realize that it just wasn't for us.



00:10 - 00:30
MasterControl is difficult and that it was piecemeal so it's almost like in frames so you could have a discussion here but it would only evolve involved a certain amount of people before it went to the next workflow stage. Then you could bring in more people to talk about it. But if something didn't sink or jive with everyone in that group, we would kick it back to the previous stage.



00:30 - 00:41
It's almost in like segments going back and forth. With MasterControl, it was very out of the box. So you didn't have the flexibility to kind of adapt it to your individual company's needs.



00:41 - 00:51
I found with MasterControl there was a lot of workflows that was multiple step approvals that I was just clicking through and approving things in order to get it from start to end.



00:51 - 00:55
Unifize makes it a lot more flexible and as more cater to your specific processes.



00:55 - 01:02
So our contract manufacturer, he had previous experience with Unifize and advocated for it heavily when he first came on board.



01:02 - 01:13
So we, I think it was within the first month of him onboarding that we had our initial meet up with the Unifize team and we fully saw its capability from that very first meeting.



01:13 - 01:17
And I think within six months we got the approval to move ahead



01:17 - 01:36
So other systems compared to Unifize would take probably six plus months before you could even start to use the system, dealt with a bunch of back end training that you had to do in order to learn how to use the system and then figuring out ways to get your data into the system. It was a lot, lot more regimented on how you can get data into the system.



01:36 - 01:56
You had to fill out spreadsheets and title all your documents. And I mean, the documentation in part was probably one of the most painful processes of the MasterControl that I've ever experienced, which again was nonexistent with Unifize. Unifize team took the data from MasterControl and uploaded it for us. In some instances, we didn't have to touch it at all.

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

01:51
Breaking organisational silos with Unifize: Centralizing knowledge and achieving organisational alignment
Jesse Kolstad emphasizes Unifize's instrumental role in dismantling organizational silos at Biovation Labs. By centralizing knowledge, the platform promotes a unified information hub, fostering organizational alignment and consistent collaboration, ensuring everyone operates in harmony.
02:23
Get to market faster by enabling agility and overcoming fear
Denis Machoka emphasizes the importance of overcoming the inherent fear of new technologies in the quest for compliance. He advocates for education to bridge the gap between rapid societal advancements and slower professional tech adaptations, stressing the need for agility in today's fast-paced world.
01:48
What does collaboration mean to Carol with Unifize
In this video, Carol Wilson from Efco delves into the essence of collaboration through Unifize, contrasting it with traditional communication methods like emails and phone calls. She highlights how Unifize's platform ensures critical information is instantly accessible, preventing delays and misunderstandings in her workflow. Carol appreciates the tool's ability to keep projects moving forward by ensuring that notifications and updates are prominently displayed to all relevant team members, making it impossible to overlook important tasks. Her experience underscores the efficiency and clarity Unifize brings to team collaboration.
03:08
How was Efco handling Returned Goods process before versus after Unifize
In this video, Carol Wilson from Efco vividly details the transformation in handling the Returned Goods process before and after adopting Unifize. She describes the cumbersome, error-prone system of managing returns via Excel, involving complex tabs and manual notifications, which often led to delays and communication breakdowns. Carol contrasts this with the streamlined, efficient process enabled by Unifize, where automated notifications and a centralized system ensure quick, accurate handling of returns, significantly improving accountability and operational efficiency. This change not only saved time but also enhanced collaboration across departments.
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.
00:56
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.
01:41
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.
02:38
Why Unifize makes post-market compliance a breeze
In this insightful video, Clarissa tackles the complexities of post-market compliance in risk management, focusing on the medical device sector. She emphasizes Unifize's pivotal role in effortlessly connecting customer complaints to corresponding solutions and risk assessments. Clarissa explains how this integration drastically cuts down the laborious task of complaint analysis, enabling proactive and efficient risk control updates, a feature she finds particularly advantageous.
01:12
Onboarding and adopting Unifize
This video outlines the swift and efficient onboarding process to Unifize for managing corrective actions, risk assessments, and change control within their quality management system. Highlighting the collaborative effort with the Unifize team, the speaker details how they were able to upload historical data and fully implement these crucial aspects within just three to four weeks—a timeline significantly shorter than anticipated. This rapid deployment, compared to previous experiences with other systems, underscores Unifize's ease of adoption and its immediate impact on enhancing the company's quality management processes.
01:41
Understanding trends by connecting data on Unifize
Jesse Kolstad accentuates Unifize's prowess in connecting data to discern trends. With robust data integration and analytical capabilities, Unifize offers valuable insights into operational trends, paving the way for data-driven decisions at Biovation Labs.
03:23
Enabling Supplier Quality on Unifize
Clarissa shares her experiences with supplier quality management on Unifize, highlighting how the platform has revolutionized this aspect of her work. She discusses the challenges of dealing with non-conforming parts from various suppliers and illustrates how Unifize aids in documenting and analyzing these issues. Through her narrative, Clarissa showcases Unifize's capability in identifying supplier performance trends, facilitating impactful discussions, and driving quality improvements, all contributing to enhanced manufacturing efficiency.
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.
02:54
What other eQMS are missing- Separating conversations from data
Denis Machoka pinpoints a critical shortfall in many eQMS: the division of conversations and data. He critiques the inefficiencies of navigating isolated data and scattered emails, championing Unifize's innovative fusion of both. By merging discussions with data, Unifize presents a unified, actionable view, streamlining decision-making and collaboration.
01:28
How I reduced Mock Recall time down to 18 minutes with Unifize
Jesse Kolstad dives deep into the world of Mock Recalls, often perceived as a compliance necessity and a cumbersome task. Highlighting the typical time constraints faced during certification audits, he recounts past experiences where meeting the set time frames was challenging. With Unifize, Jesse experienced a game-changing shift, significantly enhancing the efficiency and speed of the Mock Recall process.
02:51
Starting the transformational journey with Unifize
Detailing the transformational journey with Unifize, Jesse Kolstad emphasizes how the platform catalyzes a culture of continuous improvement. Unifize's adaptability and extensive capabilities underline its role as a game-changer in quality management at Biovation Labs.
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.
01:13
Optimising employee efficiency by setting priorities using Unifize
Seth Bozman discusses how Unifize has optimized employee efficiency at Efco, particularly among supervisors. He emphasizes the platform's role in prioritizing tasks and ensuring that rework and remake cards are processed in a timely manner, reducing unnecessary delays. Seth's account highlights how Unifize supports better resource allocation and task management, contributing to a more efficient operational flow and reducing idle times.
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.
01:10
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
How Unifize already had everything we were looking for
In their quest for a QMS that seamlessly aligns with their operations, The Will-Burt Company found Unifize's platform to be the perfect fit. Tedd Carr lauds its all-in-one capability, which encompassed core needs like internal audits, non-conformances, customer feedback, and corrective actions, eliminating the need for multiple modules. The flexibility to tailor the software to their specific processes and the inherent ease of use ensured Unifize stood out, satisfying their desire for a customizable and user-friendly system.

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.