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
Related Videos
Unifize Results
10x
Speed to compliance
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
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
01:19
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.
01:56
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.
01:26
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.
01:13
Bringing accountability and compliance into the system with Unifize
In this video, Natalie discusses how Unifize has brought enhanced accountability and compliance into their system. She emphasizes the platform's role in ensuring that every change and process is properly documented and visible, which is critical for maintaining compliance. Natalie also highlights how Unifize's collaborative features enable better communication and task management, streamlining processes and preventing errors, thereby significantly improving operational efficiency and compliance adherence.
03:00
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.
03:53
The ROI of Quality Management Systems
Jesse Kolstad delves into the significant ROI of quality management systems, underscoring efficiency gains and cost savings. Unifize emerges as a pivotal tool in optimizing the ROI of quality management, demonstrating tangible benefits at Biovation Labs.
02:45
Collaborating with vendors using Unifize
Michael elaborates on Harmonic Bionics' systematic approach to documenting design outputs, emphasizing their reliance on definitive documents such as step files and PDFs. He offers a peek into his daily routine, which frequently involves addressing quality notifications on Unifize, collaborating with vendors, and updating specifications. Through his narrative, the importance of Unifize in streamlining vendor interactions and ensuring accurate design documentation becomes evident.
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.
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.
00:47
Catching rejections by objectively looking at data and taking better decisions
In this video, Seth Bozman discusses Efco's transition from an outdated, cumbersome database system to Unifize for managing their scrap and rework data. He emphasizes how Unifize has enabled a more effective analysis of rejection reasons, offering insights into process improvements. Seth appreciates the platform's role in streamlining data management, making historical data more accessible and actionable for making informed decisions to enhance quality and efficiency.
03:57
How does Adaptive Health create a product and bring it to the market
In this video, Natalie explains the comprehensive process Adaptive Health employs to bring a new product to market. She covers the stages from initial concept and formulation through to compliance checks, quality control, and final market release. Natalie emphasizes the meticulous attention to detail and the rigorous standards that are upheld throughout the process, showcasing how Unifize plays a pivotal role in ensuring efficiency and adherence to regulatory requirements.
01:23
Quantifying things that were previously deemed impossible
In this video, Seth Bozman from Efco shares his transformative experience with Unifize, emphasizing its critical role in revolutionizing how they track and manage work orders, particularly in quantifying costs of specials and parts in a manner previously unachievable. He highlights Unifize's impact on making their process more efficient, allowing for a significant increase in productivity by enabling a more precise cost analysis and facilitating an enhanced focus on floor operations. Seth's testimony showcases the power of Unifize in streamlining operations, improving data accuracy, and supporting proactive decision-making at Efco.
02:40
How quality leaders can get the pulse of their organization without stifling innovation
Denis Machoka redefines the concept of 'quality', highlighting its role in transformation and enablement, rather than mere control. He underscores the need for effective systems that aggregate organizational information, emphasizing the importance of addressing non-conformances, failures, and supplier issues promptly to maintain high standards.
04:22
How to digitally transform your MedTech company without slowing things down
Denis Machoka recounts his pursuit of a swift digital transformation for Harmonic Bionics, leveraging the latest technologies. Drawing from his transformational background, he emphasizes achieving goals rapidly with minimal effort and gauging the team's adaptability to fast-paced changes and technological innovations.
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.
01:28
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.
03:46
Speed to market in Medtech is about empowering the quality team
Denis Machoka discusses the factors influencing speed to market in Medtech, focusing on the complexities of implementing a quality system. He underscores the detailed understanding of workflows, IT support needs, security considerations, and the potential high costs and maintenance of many systems, emphasizing their impact on the final product's cost.
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.
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.
01:28
Importance of collaboration between Product Development and Quality
Natalie emphasizes the crucial importance of collaboration between product development and quality teams in this insightful video. She discusses how Unifize has facilitated this collaboration, particularly in the ingredient review process and creation of master formulas. Natalie highlights how Unifize has brought about greater accountability, compliance, and efficiency in ensuring that the desired product formulations are accurately created and maintained.
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
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.
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.
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.
