What is the challenge with managing a QMS actively
In this video, Wilson delves into the challenges of actively managing a Quality Management System (QMS). They reveal how manual processes, over the years, made the QMS cumbersome, deterring the team from utilizing it fully for new product development and quality control. Highlighting a shift towards an electronic QMS to mitigate these issues, the speaker underscores the importance of a QMS in improving business operations, controlling quality output, and fostering continuous improvement, stressing that an efficient QMS is vital for operational success.
Transcript

00:00 - 00:10
Well, something that we have that's always been an issue for us has been the ability to stay on top of actively managing the quality management system.



00:10 - 00:44
I think I started looking at options for moving to electronic quality management system just a few years ago because I had realized over the past probably three years, 3-4 years that the amount of manual work required to operate the quality management system was becoming so onerous that the team was less likely to utilize the processes put into place, documentation put into place to move new product development or just basic quality control processes along.



00:44 - 01:06
We weren't leveraging our quality management system to its fullest potential to help improve how we do our day to day business operations. And that's the whole point of having a quality management system in the first place is to be able to identify, control, document, and then create improvements in how those core business practices affect the quality output of your product,



01:06 - 01:19
How that entire system works, and if the mechanics of how that quality management system operate are so difficult to work with in the first place, or so resource intensive, then it becomes a self-defeating prophecy.

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

00:38
About Seth and his role at Efco
Seth Bozman introduces himself and his role at Efco, detailing the company’s operations and his responsibilities in managing scrap and rework. He discusses the transition from traditional methods to utilizing Unifize, highlighting the platform's impact on improving data analytics, reporting, and operational efficiency. This video provides a personal insight into Seth's professional journey and the transformative effects of Unifize on his work at Efco.
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.
02:42
Why you can't use Slack and Teams to build life science products
In this video, quality leaders from a popular nutraceutical manufacturer, Adaptive Health share their experience on using communication tools like Slack and Microsoft Teams to manage quality. They emphasise on the fact that these tools disconnect the collaboration from the data, leading to greater redundancies affecting their product launch process. They also share their experience on using Unifize to manage their quality processes end-to-end, and how it improved their collaboration and data management tremendously not just within their organisation, but across their partner organisations as well. Watch this video to know more about why Slack and Teams cannot replace a powerful collaborative eQMS solution like Unifize.
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.
01:11
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.
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.
01:49
How big is Adaptive Health in the Dietary Supplements market
Mikala discusses the significance of Adaptive Health in the dietary supplements market. She talks about the company's market position, its range of products, and its commitment to quality and compliance. Mikala highlights how Unifize has been a key tool in maintaining their competitive edge and ensuring consistent quality in their product offerings, thereby solidifying their market presence.
01:52
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.
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.
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.
01:32
Experience with MasterControl
In this detailed account, Mikala compares her experiences with MasterControl and Unifize. She outlines the challenges faced with MasterControl, such as its complex, time-consuming processes, and inefficiency. Mikala then contrasts this with the user-friendly and effective operations provided by Unifize, emphasizing its streamlined approach and significant improvements in operational efficiency, process simplification, and overall user satisfaction.
03:23
About Denis Machoka and his role as VP of Quality at Harmonic Bionics
Denis Machoka, VP Quality at Harmonic Bionics, shares his evolution from a scientist with a background in chemistry and biology to a Quality Systems expert. He delves into his experiences in laboratories, IT systems implementation, and his expertise in qualifying systems within regulatory frameworks.
01:03
How to effectively utilize Unifize
In this insightful video, Carol Wilson from Efco discusses the critical success factors for implementing Unifize within an organization. She emphasizes the necessity of company-wide adoption, from top-level management to every department, to fully leverage Unifize's capabilities. Carol shares her firsthand experience with the platform, highlighting how comprehensive engagement ensures seamless collaboration and efficiency. She underscores the importance of management endorsement and following through on processes to realize the full potential of Unifize, reflecting on its impact on audits and data management.
01:27
How approvals in Unifize helped us collaborate across organizations and get things turned around faster
Mikala discusses how Unifize's approval features have enhanced collaboration across different organizations and expedited turnaround times. She highlights the platform's ability to streamline approvals, improve communication, and facilitate quicker decision-making. Mikala shares specific instances where Unifize's efficient approval processes have led to faster resolutions and better collaboration, underscoring its impact on operational efficiency.
04:59
How Denis builds a quality culture in MedTech companies
Denis Machoka, a Six Sigma black belt, highlights his transformative approach to Medtech companies. He shares insights on assessing an organization's current state and vision, the critical role of communication in building a quality culture, and the essential tools to foster knowledge and improvement.
01:02
What are the compliance standards followed at Adaptive Health
In this video, Mikala outlines the compliance standards followed at Adaptive Health. She delves into the various regulatory requirements they adhere to and how maintaining these standards is critical for their operations. Mikala explains how Unifize plays a vital role in ensuring compliance, managing documentation, and streamlining processes to meet these rigorous standards effectively.
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.
06:33
What it really means to Unifize your information and people
Clarissa Archer shares the transformative impact of Unifize on Harmonic Bionics' operations. Beyond just a QMS, Unifize emerged as a tool that seamlessly connected people and information. Whether dealing with complex scenarios like non-conformances or change orders, the platform ensured they always had a holistic view, enhancing clarity and decision-making.
01:18
Getting better visibility using Unifize Dashboards
Clarissa enthusiastically discusses the advantages of Unifize Dashboards in improving visibility and workflow management. She describes how custom dashboards can alert specific teams about pending tasks, like change orders awaiting implementation. Clarissa appreciates the dashboards' ability to prioritize tasks and centralize information, highlighting their role in streamlining operations and fostering team collaboration.
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.

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.