How Unifize helped us streamline Change Requests
Mikala shares her experience with streamlining change requests using Unifize. She talks about how the platform has simplified the process, improved tracking, and increased transparency. Mikala emphasizes the importance of efficient change management in maintaining product quality and compliance, and how Unifize has been instrumental in making these processes more manageable and effective.
Transcript

00:00 - 00:23
Change Requests, we use in all areas of the quality process. So for updating formulations, if we are adding new approved suppliers that would initiate a change request. Changes to our artwork, I know that our contract manufacturer uses change request to update work definitions, further batch records in our ERP system, Oracle.



00:23 - 00:35
Document revisions is very simple. Usually we trigger it through a change request because everything can be linked into the system in Unifize, initiating a change request, we can easily identify what type of change it is.



00:35 - 00:49
It'll then instruct us to link the necessary conversation type to it. We link that in and then it pushes out taskers for individuals to go through and update any of the linked document types that are within that change request.



00:49 - 00:53
And it kind of tracks each of these tasks. So as soon as they complete their part, they mark it as approved.



00:53 - 01:04
So the person who's responsible for making sure the change request was closed out could easily see from a bird's eye view. Like if everything's been done, once it's done, they can just approve it.



01:04 - 01:13
And the beauty with the linkages is I know previously to using Unifize, we had a lot of documents that carry a lot of the same data, but they're all in Excel or Word.



01:13 - 01:27
So you're going to each of these various document types and updating to make the same change. Whereas now you can make one change on the parent document and are automatically just changes it on everything. So reducing your time there to make the update.



01:27 - 01:38
There's a quick revision feature and then you mark it as current and again, the change request is already tied to it. So all the information as to why it was updated and the approval for that update is already tied to it.



01:38 - 01:43
And as soon as you click the request for approval and the individual approves it, it marks it as current.



01:43 - 01:47
And unless you have the necessary rights, no one else will ever see the other revisions.

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

03:26
Building a knowledge base in a startup with Unifize
Michael delves into the distinctive aspects of working in a compact company setting. He underscores the pivotal role of relationships, whether with colleagues, suppliers, or clients. Highlighting the importance of human-centric approaches in startups, Michael contrasts this with the rigidity and compartmentalization of vast corporations. His reflections shed light on the balance between the personal touch and systematic workflows in different company sizes.
02:05
How Unifize speeds up approvals around product specifications
In this video, Jesse Kolstad of Biovation Labs elaborates on the intricacies of product specifications, from dosage forms to market presentations. He underscores the comprehensive role Unifize plays in the process, highlighting the platform's capability to manage, collaborate, and monitor all aspects of finished products. Jesse reflects on the transformative shift from traditional email-based approvals to the more efficient system provided by Unifize.
00:36
Minimising the impact on IT while implementing Unifize
The Will-Burt Company strategically chose Unifize to alleviate their IT department's workload. Tedd Carr appreciates that Unifize's team handled everything from installation to launch, ensuring minimal IT involvement. This approach not only streamlined the implementation process but also allowed their IT staff to focus on other critical internal tasks, marking a significant internal shift towards efficiency and resource optimization.
00:47
What would happen if Unifize was taken away from Natalie
In this video, Natalie shares her thoughts on the impact of potentially losing access to Unifize. She describes how integral the platform is to her daily operations and the significant setbacks that would occur without it. Natalie underscores the platform's role in streamlining processes, ensuring compliance, and facilitating effective communication, emphasizing its indispensability in her work routine.
00:49
Document control with Unifize
This video from Wilson illustrates how Unifize transforms document control, making it more organized and accessible. The speaker discusses the benefits of centralized document management, including improved traceability, reduced errors, and enhanced collaboration, which are vital for maintaining quality standards and regulatory compliance.
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.
01:41
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.
02:54
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.
01:00
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.
02:25
Implementing a collaborative eQMS in 4 weeks
Clarissa Archer recalls the initial days of Harmonic Bionics' adoption of Unifize. While they had experience with systems that took ages to configure, Unifize stood out with its rapid setup. Working closely with the Unifize team, they tailored the system to their unique requirements, finding it far more adaptable than larger systems like Agile.
01:58
The one important feature that sold the deal for Seth
Seth shares his enthusiasm for Unifize's filtering capabilities, which revolutionized how Efco manages its data. This feature allowed for a more organized, efficient way to access and analyze information, significantly impacting decision-making processes. Seth’s account highlights Unifize’s flexibility and its ability to adapt to specific user needs, showcasing how this single feature made a profound difference in operational efficiency and data management at Efco.
01:23
Why Unifize was such a breath of fresh air in the quality management world
This video highlights Unifize's innovative impact on the quality management sector, praising its user-friendly interface, flexibility, and comprehensive features. The speaker describes how Unifize stands out from traditional QMS solutions by encouraging proactive engagement and simplifying complex processes, making quality management more accessible and effective.
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.
03:13
How Unifize's collaboration empowers continuous improvement
Jesse Kolstad heralds Unifize's transformative impact on collaboration at Biovation Labs, empowering continuous improvement through open communication. By breaking down silos and fostering cross-functional collaboration, Unifize establishes real-time feedback loops, ensuring alignment with company objectives and facilitating rapid growth.
01:29
Auto generating reports with formulas using Unifize
Seth Bozman highlights the transformative impact of Unifize's formulas and auto-generator features on Efco's cost analysis and quality reporting. He shares how these features have eliminated the need for manual data entry into external databases, significantly reducing the time spent on generating quality reports. This video showcases Unifize's capability to automatically calculate costs, offering Efco a streamlined, efficient approach to tracking and analyzing scrap and rework data.
02:43
About Wilson and Applechem
Wilson introduces Applechem, detailing their focus on innovation in cosmetic ingredients. He emphasizes their commitment to developing high-quality, cutting-edge products that cater to the evolving needs of the cosmetics industry. This introduction sets the stage for understanding Applechem's market position and Wilson's role in steering the company towards its goals.
01:23
How we use Unifize as an engineering system of record
Michael delves into his daily tasks, emphasizing his continuous engagement with vital processes such as change orders and quality notifications. He reveals that Unifize constitutes a significant chunk of his workflow, attributing this to the platform's central role as the engineering document of record. Whether it's creating presentations for design reviews or other tasks, Unifize stands as the go-to platform for all engineering outputs.
01:12
How conversations in Unifize foster better collaboration
Tedd Carr is enthusiastic about how Unifize's conversation-driven platform has revolutionized collaboration at The Will-Burt Company. He observed a significant uptake in engagement following a refresher course, likening the buzz of activity to a lively slot machine. This surge in conversations among varied personnel didn't lead to confusion but rather an organized flow of information. Carr takes pride in witnessing the team's proactive interactions and the smooth progression of tasks, indicating a thriving, collaborative environment.
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.
01:24
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.

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.