Reducing the time to resolve customer complaints on Unifize
Jesse Kolstad highlights how Unifize expedites the resolution of customer complaints. Offering tools for rapid issue identification and fostering team collaboration, Unifize streamlines the complaint resolution process, ensuring accountability and efficiency in addressing customer concerns.
Transcript

[00:00 - 00:05]
The beauty of the customer complaints conversation that I have and Unifize is that it's immediately connected to the Finished



[00:05 - 00:27]
Good Lot, because customers when they complain, are always talking about a product, a bottle a Lot and rather than having to take what they said and go open file cabinets and emails and looking here and there, you just, oh, this is a Lot. And then just like I can scan it out in the warehouse by connecting that Lot, the Finished Good Lot into the customer complaint thing.



[00:27 - 00:37]
I can see everything about that Lot. So I can do my quality investigation, my root cause analysis right then and there as just by saying, Oh, this is the Lot number on the bottom of that bottle.



[00:37 - 00:56]
Let's take a Non-Conformance that I recently had a it's an email from an outside customer. They say we had problem X and we all we needed was the Lot on the bottom of it and we're already off to the races. I mean, you're already 70% done just by doing that because all of the history of that product and that Lot is in Unifize.



[00:56 - 01:13]
So then you can from there figure out when, where, who, what, why. And it is it is right away the most powerful thing that Unifize does for those kind of quality events is it allows you to see the scope immediately. So is it a is it a one off or is could this be 10,000 bottles



[01:13 - 01:37]
Probably the first most important question when you when you deal with these things and having that answer by virtue of just saying here's the Lot number dramatically decreases the time that it takes to appropriately, effectively investigate and find the true root cause and the impact both financially and from, you know, brand awareness and risk and compliance.

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

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.
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.
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 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.
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.
Evaluating other eQMS software tools
Denis Machoka delves into the evaluation process of various eQMS tools, citing considerations for present needs and future growth. Comparing Unifize to platforms like Ignite EDMS, Veeva, and Greenlight Guru, he underscores Unifize's ease of implementation and its integrated conversation feature as standout advantages.
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.
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.
Hear about things in real-time and start conversations early on with Unifize's mobile capabilities
Tedd Carr discusses the significant advantage brought by Unifize's mobile functionality to The Will-Burt Company. With a web and cloud-based system, Unifize's mobile app enables their sales force to initiate quality conversations and address customer concerns instantly while on the move. This real-time communication capability has proven to be a valuable tool, fostering timely discussions and swift issue resolution, and is especially praised by those who often work remotely or travel.
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.
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.
The simplicity of the Unifize onboarding process
Denis Machoka praises the effortless onboarding process with Unifize. Pre-established access matrices ensured a smooth transition. He lauds the platform's ease of setup, where users quickly received access links on their devices, and emphasizes the consistent user experience across multiple platforms, highlighting its adaptability.
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 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.
How we manage change on Unifize
Michael offers a behind-the-scenes look into the engineering practices at Harmonic Bionics. He talks about his reliance on tools like SolidWorks for computer modeling and Apache subversion for version control. Despite a limited software stack, there's a hands-on approach to their work, encompassing tasks from debugging robots to prototype development. Michael underscores the systematic approach they follow in documenting design outputs, hinting at the role of Unifize in this process.
How Unifize helped build our processes efficiently from scratch
In this video, Jesse Kolstad of Biovation Labs contrasts his experience with MasterControl's structured modules to the flexibility offered by Unifize. Reflecting on the early stages of his career, Jesse appreciated the structured guidance, but as his expertise grew, he found immense value in the "blank canvas" approach of Unifize, allowing for tailored and efficient process development.
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.
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.
Managing Incoming Material and Lot Tracking on Unifize
In this video, Clarissa discusses the challenges and solutions for managing incoming materials and lot tracking using Unifize. They emphasize the difficulties faced in quality assurance, especially when parts or products do not meet inspection standards. The video illustrates how Unifize streamlines this process by enabling easy tracking of lots, keeping essential documents like certificates of conformance and material certificates organized. The speaker highlights the convenience of having all relevant information, such as lot numbers and PO numbers, scanned and stored in Unifize, facilitating efficient tracking and inspection. They conclude by praising Unifize's collaborative features, which significantly enhanced their team's engagement with the new Quality Management System (QMS).
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.

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.