How Unifize ensures everyone is trained on the right version of documents and SOPs
Jesse Kolstad sheds light on the intricacies of document control, a critical component across regulated industries. While debunking common myths, he underscores the importance of more than just maintaining master copies. With Unifize, the emphasis is on ensuring that everyone in the organization is well-trained and aligned with the most recent versions of documents and SOPs, guaranteeing compliance and efficiency.
Transcript

[00:00 - 00:19]
So with regard to document control, which is something that's required in the regulations and it's something that's ubiquitous to every quality group across the board in this industry. And actually any regulated industry for the most part, in my experience from a neutral infant formula, I mean, they all have their own set of guidelines and controls.



[00:19 - 00:49]
I think it's even I sort of have them on right. And a lot of people think doc control is quite literally: I have a signed, approved master copy and I put it in a file cabinet and I control it then. And every and I mean every quality management system bolt on to an inventory management system. I've worked with LIMS systems they, they all approach you first and foremost as a doc controller, which I think is a it's shortsighted because MasterControl did this.



[00:49 - 01:09]
They'll come at you and say, we can store your documents, will, so can a file cabinet, so can an email server. So I mean, and people get romantic about that and they and they like that and they said this is what I need. I need to be able to store it electronically. What do you do is that that powerful and Unifize gave me that.



[01:09 - 01:13]
I mean right away I was able to I have all my SOPs. I digitally signed them.



[01:13 - 01:23]
But Unifize give me the ability to go one step further because when you have aStandard Operating Procedure, your SOPs, well, those you don't have them just to have them because the regulations say you need them. They're supposed to be yourStandard Operating Procedure.



[01:23 - 01:54]
Right. But that requires training. So somebody needs to understand how to do their job via the Standard Operating Procedure. That's how they operate. And who needs that training? Well, there's different job descriptions across the company. You have your operators, you have your maintenance techs, quality techs, etc., etc.. So who needs what training from that SOP and Unifize allowed me to start my SOP, build my training, attach that to all the jobs that's that it's meant for.



[01:54 - 02:13]
And then I went the last step was okay, what employees are in those jobs? And so day one employee start and their training is right in front of them and they have one button access to the reference documents, which is helping me to build that sort of Holy Grail with regard to quality compliance and training of having them use our SOPs



[02:13 - 02:18]
Because there our SOPs, not because we wrote them.

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

The problems Tedd faced with managing multiple quality systems
Mired in an archaic quality system since 1994, The Will-Burt Company grappled with a maze of spreadsheets and disjointed programs until Unifize revolutionized their process. Tedd Carr shares how their transition to Unifize's singular platform dissolved the cumbersome task of correlating data across five different systems, unveiling trends and accelerating efficiency in quality management.
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.
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.
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.
Managing retentions with Unifize
Jesse Kolstad underscores Unifize's role in effectively managing product retentions at Biovation Labs. The platform simplifies tracking, ensures adherence to retention policies, and enhances compliance, making retention management more streamlined and reliable.
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.
Transitioning from an existing eQMS to Unifize
Highlighting the transition from a traditional eQMS to Unifize, Jesse Kolstad lauds the platform's flexibility and advanced capabilities. With its user-friendly interface and transformative features, Unifize has brought about significant operational improvements at Biovation Labs.
Avoiding the mistake of thinking you need a complex QMS software to scale
Denis Machoka addresses misconceptions in QMS, emphasizing the value of easily accessible information for compliance. He challenges the notion that larger, more complex systems are inherently better, suggesting that simplicity and efficiency should be the focus.
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.
Doing 95% internal audits remotely with Unifize
The Will-Burt Company's pivot to remote operations, as narrated by Tedd Carr, showcases the agility afforded by Unifize. Amid travel restrictions, they've successfully shifted 95% of internal audits to a remote format, utilizing Unifize to maintain stringent compliance without the need for physical presence in their Tulsa location. This transition underscores Unifize's conversational-driven software's strength in facilitating seamless and efficient audit processes.
How to take the plunge on an eQMS- build consensus across the company
Denis Machoka shares Harmonic Bionics' collaborative approach to choosing an eQMS. The team collectively identified and categorized desired system attributes, ensuring the chosen system reflected the team's consensus. This method involved engaging with vendors that met their defined criteria.
Managing part revisions on Unifize
Michael sheds light on the intricacies of managing part revisions at Harmonic Bionics using Unifize. He describes their systematic approach, where each part is tagged with a specific revision. This setup allows team members, like purchasers, to seamlessly access and review older versions of parts when needed. Michael values Unifize's capability to store and present all relevant information, from product definitions to design files, ensuring a comprehensive understanding of each part's evolution.
Why Biovation moved from MasterControl to Unifize
Jesse Kolstad reminisces about his journey with quality management systems, notably his pivotal role in deploying MasterControl. As he navigates through the landscape of electronic documentation circa 2016, he highlights the challenges presented by platforms like SharePoint. While acknowledging MasterControl's early advantages, Jesse candidly critiques its user interface, shedding light on why a transition to Unifize became essential for Biovation Labs.
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.
About Michael Hogan & Harmonic Bionics
Michael Hogan, a mechanical engineer at Harmonic Bionics, paints a vivid picture of the company's origins. He recounts the early days when it was just a group of grad students from the Renew Robotics Lab passionately working on rehab robotics. Their flagship device, Harmony, emerged from these efforts, aiming to revolutionize the recovery process for stroke patients.
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.
Managing your Design History File on Unifize
In this video, Clarissa talks about the transformative experience of managing Design History Files (DHF) using Unifize. She contrasts the challenges of traditional DHF management with the streamlined, intuitive approach offered by Unifize. Clarissa details how the platform efficiently links various documents, processes, and reports, facilitating a smoother review process for manufacturing readiness and design transfers, a feature she finds exceptionally beneficial for product development.
How Unifize's no-code configuration speeds up implementation
Clarissa Archer emphasizes the significance of adaptability in Harmonic Bionics' choice of a QMS. With Unifize, they could shape the software to their specific needs, bypassing the rigidity of traditional systems. The power to make direct adjustments without relying on external teams was a game-changer for them, speeding up processes significantly.
How Unifize's configurability helped us fight the resistance to change
Tedd Carr highlights the configurable nature of Unifize as a pivotal element in overcoming resistance to change at The Will-Burt Company. He values the software's adaptability, allowing for a familiar feel akin to their previous systems, thus simplifying the transition. The Unifize platform mirrors their old forms but with a new, conversation-driven approach, resulting in a smoother learning curve and quicker adoption among staff, leading to a more relaxed and progressive work environment.
How Unifize helps save time and get things done faster
In this video, Michael from Harmonic Bionics celebrates the transparency and coherence Unifize offers. He values the platform's ability to keep everyone synchronized, viewing the same documents and chat histories. This clear and shared understanding of processes, from part designs to quality notifications, not only fosters efficiency but also lets Michael concentrate more on his primary responsibilities, enhancing productivity.

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.