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.

00:00 - 00:04
In terms of validation, Unifize is comes validated.

00:04 - 00:15
The organization provides validation package. The configuration is an easy part of it because you have to do is document what your configuration is. But the core validation is already completed.

Unifize Results

Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs

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

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.
Accelerating feedback loops by creating transparency using Unifize
Denis Machoka highlights the transformative power of transparency through Unifize, emphasizing clarity in responsibilities and priorities. He praises its capability to communicate seamlessly with a broad audience and values its mobile integration, enabling real-time updates without the need for multiple tools or email checks.
The ROI of a collaborative, configurable eQMS
Denis Machoka elaborates on the ROI derived from Unifize as a collaborative eQMS. He underlines that true ROI is reflected in compliance, data accessibility, and the defense of information. Denis commends Unifize's capabilities in showcasing regulatory control and its adaptability to adjust control levels based on data sensitivity.
Comparing Unifize to other eQMS software
Clarissa Archer narrates Harmonic Bionics' journey in searching for an optimal QMS. Evaluating various systems, they prioritized features like change control, product lifecycle management, and electronic signature compliance. While they considered prominent systems like Master Control, ETQ, and Greenlight Guru, their quest for seamless collaboration was paramount.
Three reasons why Unifize is the easiest QMS- Security, simplicity, compliance
Denis Machoka advocates for Unifize as a QMS, praising its exceptional ease of implementation and intuitive design. Drawing a comparison with other renowned systems, he emphasizes Unifize's simplicity and rapid setup, making it a standout choice in the realm of quality management syst
Why Unifize makes post-market compliance a breeze
In this insightful video, Clarissa tackles the complexities of post-market compliance in risk management, focusing on the medical device sector. She emphasizes Unifize's pivotal role in effortlessly connecting customer complaints to corresponding solutions and risk assessments. Clarissa explains how this integration drastically cuts down the laborious task of complaint analysis, enabling proactive and efficient risk control updates, a feature she finds particularly advantageous.
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.
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.
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.
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 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.
Why it was easy to win the hearts and minds of engineers about Unifize
Denis Machoka reveals how Unifize's simplicity and instant information accessibility resonated with engineers at Harmonic Bionics. The platform's integrated conversations enabled engineers to quickly grasp expectations and engage in substantive discussions, streamlining communication and boosting efficiency.
Getting engineering to adopt a new eQMS
Clarissa Archer reflects on Harmonic Bionics' transition from a research-centric organization to one focused on compliance. She reminisces about the sudden surge in documentation and the challenges it presented to engineers and product developers. Accustomed to flexible laboratory environments, the team had to adapt to the structured, documentation-heavy world of compliance, making the choice of a user-friendly system like Unifize crucial.
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.
How Unifize helped reduce our training time and costs
Jesse Kolstad discusses the transformative role Unifize played in Biovation Labs' training process. By establishing a cohesive link between SOPs, training modules, job roles, and employees, Unifize brought unparalleled structure. Jesse also introduces a novel approach of integrating QR codes on RFID badges, allowing for on-the-spot verification of an employee's training status. This innovative system streamlined compliance checks and significantly cut down on training costs.
Near instant implementation and adoption of Unifize
Jesse Kolstad lauds Unifize for its intuitive design and quick adoption. With tools that foster user engagement and autonomy, Unifize integrates smoothly into Biovation Labs' daily operations.
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 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.
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).

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.