Investigating deviations with Unifize
The video explains Unifize's approach to managing deviations, emphasizing the platform's effectiveness in identifying, analyzing, and resolving discrepancies swiftly. It highlights how Unifize facilitates a comprehensive investigation process, contributing to higher standards of quality and compliance.
Transcript

00:00 - 00:43
You know, I think it really, right now for us where Unifize has shined in that respect is not so much on the raw material approval side. It has been on the corrective action side. The initial investigation, what went wrong and why, and especially if it involves external parties, third party contract manufacturers, other raw material vendors and suppliers, the ability for Unifize to be able to bring those outside parties into the conversation within your internal platform without a single person pinging emails back and forth, “Hey, this lot number didn't work. We found this and that one, this QC person over in this company said this, but they're cute to him. Their quality assurance manager said that.”



00:43 - 01:08
Trying to keep track of all those things and then being, having to be the point person that informs the rest of your internal team of what those conversations look like. Being able to have Unifize just be a natural part of that investigative process when you're trying to inform all the parties involved of what the current status is of an open deviation and why we think that occured, possible sources of the quality issue and so on, so forth.



01:08 - 01:37
That's where I've seen the immediate benefit. You know, when we have a quality issue that arises, say, with the third party contractor, I could just loop that their quality person directly in to the open carrot we have on Unifize itself. They can see the conversation we've had so far about potential sources of the quality issue in the first place, and then they could provide their feedback and then we can just update the counter form right there instead of waiting till weeks afterwards.



01:37 - 02:03
What sometimes happens is you can have these emails, you can have these conversations on the phone, you have these meetings with these external providers. But then when it comes time to actually updating your corrective action documentation, you have to go back and remember what you guys talked about. If you're not doing it right then, then it becomes much more difficult one week, two weeks, three weeks later on the process to be able to accurately recall and input all the potential solutions that you've discussed.



02:04 - 02:26
You're relying on memory and bits and pieces of information in different emails to piece together in order to recreate that information to put into your quality management system. And with Unifize, you don't you're not forced to do that, or the possibility of that occurring is reduced because you could just tap it in right there, as a conversation is happening.



02:26 - 02:36
When it comes to documentation and compliance, it's not a linear process where everyone is looking at the same thing at the same time all the time.



02:36 - 02:42
People are in their day to day workflow, are doing so many different things at once.



02:42 - 02:59
That information isn't synchronized in any way. So the more you're able to build in your compliance process, your documentation process into that day to day activity without increasing the resources required to execute the process, Unifize gives us the option to actually do that.



02:59 - 03:06
And right now it's really shown itself for us in being able to execute corrective actions for for the company.

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

02:42
About Harmonic Bionics- a robotics MedTech company in Austin, Texas
Harmonic Bionics, based in Austin, Texas, designs robots to assist in upper chest healing for patients with mobility challenges, especially those recovering from strokes. By facilitating limb movements, these robots aid in retraining neural connections. The company is FDA-registered and collaborates with the University of Texas for research.
01:33
How to make facing FDA audits easy
Clarissa Archer talks about the daunting experience of preparing for audits, especially from rigorous bodies like the FDA. She stresses the importance of a robust documentation system, serving as a "source of truth" during these audits. With Unifize, they could effortlessly produce, present, and recall documentation, simplifying the audit process and instilling confidence in their decisions and actions.
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.
01:53
About Jesse Kolstad
Jesse Kolstad, the Director of Quality, Compliance, and Formulation at Biovation Labs, gives an intimate peek into his role and the company's operations. Located in Salt Lake City and part of the Wellful organization, Biovation Labs plays a pivotal role in manufacturing capsules and tablets. Jesse also highlights their collaboration with prominent industry giants, underscoring Biovation's significance in the dietary supplement sector.
05:37
Streamlining Change Control on Unifize
In this video, Clarissa shares her experience with Unifize, emphasizing its impact on change control and document management in quality management systems. She highlights the challenges of maintaining up-to-date engineering drawings and documentation, particularly in a traditional pen-and-paper environment. Clarissa illustrates how Unifize streamlines these processes, ensuring engineers access the latest revisions, understand changes, and comply with FDA requirements. She praises Unifize's integrated checklist feature and approval process, which simplifies change orders and prevents delays, even when key personnel are unavailable. Clarissa's testimonial underscores Unifize's efficiency, detailing how it transformed their change control process from a lengthy endeavor to a more manageable and efficient system.
01:00
Why does Seth consider Unifize's Customer Support, urgent?
In this video, Seth highlights the exceptional customer support provided by Unifize, detailing his interactions with the team and their responsive, solution-oriented approach. He appreciates the platform’s ability to address urgent requests swiftly, enhancing Efco’s operational efficiency. Seth’s experience underscores Unifize’s commitment to customer satisfaction and its impact on streamlining workflows and resolving issues quickly.
02:12
How smaller groups lead to 70% faster actions
In this video, Dave Anderson from Efco shares his transformative experience with Unifize, emphasizing how the platform fostered smaller, more efficient discussion groups to swiftly address problems. By enabling seamless collaboration and record-keeping online, Unifize ensured that all stakeholders stayed informed and engaged, leading to a remarkable 70% improvement in action response times. Dave highlights the significant reduction in administrative overhead, from managing paperwork to leveraging Unifize’s streamlined processes, showcasing the platform's impact on enhancing productivity and resource allocation.
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.
01:15
Resolving non-conformances in just hours with Unifize
In this video, Mikala discusses how Unifize has revolutionized the handling of non-conformances in their products, reducing resolution time from days to mere hours. She highlights the software's ability to initiate non-conformance processes directly and efficiently, linking all relevant data to the identified issue. Mikala emphasizes the ease with which users can trace raw materials and other factors contributing to the non-conformance, leading to a significant decrease in the time spent documenting and resolving such issues.
02:10
About Mikala and her role at Adaptive Health
In this video, Mikala introduces herself and elaborates on her role at Adaptive Health. She discusses her responsibilities in overseeing quality management and compliance processes. Mikala explains how her role is crucial in ensuring product quality and adherence to regulatory standards, and she emphasizes the importance of using efficient tools like Unifize to maintain high standards in the dietary supplements market.
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.
02:48
What are the quality standards followed at Applechem
This video outlines the stringent quality standards Applechem adheres to in its product development process. Emphasizing compliance with global regulatory requirements and a commitment to safety and efficacy, it showcases the company's dedication to maintaining high-quality benchmarks in the cosmetics industry.
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.
02:15
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.
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.
00:24
Unifize - a validated QMS software
Denis Machoka elaborates on the validation credentials of Unifize as a QMS software. He underscores that Unifize is pre-validated, comes with a comprehensive validation package, and emphasizes the simplicity of its configuration, stressing the need for proper documentation.
01:25
Wear a seatbelt using Unifize to avoid accidents and save money
Drawing a parallel with wearing a seatbelt, Jesse Kolstad elucidates how Unifize serves as a preventive tool, averting operational mishaps at Biovation Labs. Ensuring safety and compliance, Unifize's proactive features lead to significant cost savings by forestalling potential issues.
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.
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.
01:48
About Tedd and The Will-Burt Company
Tedd Carr, with 40 years at The Will-Burt Company, oversees a broad quality assurance and control remit that spans beyond the traditional confines of the department. His role touches all company areas, emphasizing the diverse and complex quality demands of their varied customer base in sectors such as aerospace and military, which presents a significant challenge in meeting each sector's unique requirements and expectations. The Will-Burt Company, an employee-owned enterprise, prides itself on a century of business, specializing in proprietary products and services for emergency communications, warfare, and payload elevation, as well as offering comprehensive manufacturing services.

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.