Handling audits made simple with Unifize
The video details how Unifize has simplified the audit process, making it easier to present and access required documentation. It demonstrates the platform's ability to consolidate information in a central location, significantly reducing the time and effort involved in audit preparation and execution.
Transcript
Related Videos
Unifize Results
10x
Speed to compliance
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
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
02:47
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.
01:26
What would happen in the absence of a collaborative eQMS like Unifize
In this video, Natalie discusses the potential consequences of not having a collaborative eQMS like Unifize in place. She emphasizes the crucial role Unifize plays in maintaining efficient and compliant operations. Natalie points out how the absence of such a system would lead to disorganization, inefficiency, and potential non-compliance issues, highlighting the importance of a centralized and integrated platform for managing quality in a regulated environment.
07:00
How Unifize's real time collaboration empowers faster and efficient decision making
In this video, Jesse Kolstad of Biovation Labs accentuates the power of Unifize's real-time collaborative environment. He praises its capability to manage multiple tasks concurrently, leading to significant time savings, increased visibility, and enhanced communication. Jesse emphasizes how this real-time collaboration facilitates swift and effective decision-making.
02:05
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.
02:11
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.
01:13
Reviewing documentation in half the time with Unifize
In this informative segment, Erica enthusiastically discusses how Unifize revolutionizes supplier audits and ingredient management. She delves into the platform's intuitive interface, allowing for easy document uploads and efficient tracking. Erica emphasizes the significant time-saving benefits, noting how Unifize cuts down task durations dramatically with its customized checklist feature. She illustrates the stark contrast between the traditional, time-consuming methods and Unifize's streamlined approach, concluding with praise for the platform's drag-and-drop functionality. This segment effectively highlights Unifize's transformative impact on simplifying and accelerating quality control processes.
03:16
Using Unifize to track Non-Conformances and Deviations
Clarissa delves into the intricacies of tracking production deviations and non-conformances through Unifize. She sheds light on the platform's adeptness in generating quality notifications, seamlessly linking them to specific parts, suppliers, and relevant processes. Clarissa underscores how this functionality not only aids in pinpointing recurring quality issues but also streamlines the management of corrective actions. Her enthusiasm is evident as she details Unifize's role in enhancing quality tracking and review processes.
00:34
What collaboration means to Dave
In this video, Dave Anderson passionately discusses the essence of collaboration through Unifize. He emphasizes the significance of having smaller, focused groups tackling specific issues such as scrap or rework. Dave appreciates how Unifize facilitates open discussions, allowing for collective problem-solving where no single individual holds all the answers. This collective approach brings diverse ideas to the forefront, enhancing the problem-solving process. Dave's testimonial underscores the value of collaboration in fostering a more innovative, efficient, and inclusive work environment.
02:00
What made us switch from MasterControl to Unifize
In this comprehensive narrative, Mikala explores the decisive factors that led to the switch from MasterControl to Unifize. She discusses the limitations and challenges she faced with MasterControl, including its inefficiency and user-unfriendliness. Mikala then delves into the aspects of Unifize that prompted the change, such as its innovative approach, user-centric design, and efficiency, which have significantly improved their operational processes and overall workflow management.
03:26
Building a knowledge base in a startup with Unifize
Michael delves into the distinctive aspects of working in a compact company setting. He underscores the pivotal role of relationships, whether with colleagues, suppliers, or clients. Highlighting the importance of human-centric approaches in startups, Michael contrasts this with the rigidity and compartmentalization of vast corporations. His reflections shed light on the balance between the personal touch and systematic workflows in different company sizes.
00:34
How big is Applechem
Applechem's current size and plans for expansion are discussed, indicating the company's growth trajectory. With 18 employees and a facility of 18,000 square feet set to expand to 42,000 square feet, the video highlights Applechem's increasing capacity for R&D, manufacturing, and warehousing in response to business growth.
02:25
Implementing a collaborative eQMS in 4 weeks
Clarissa Archer recalls the initial days of Harmonic Bionics' adoption of Unifize. While they had experience with systems that took ages to configure, Unifize stood out with its rapid setup. Working closely with the Unifize team, they tailored the system to their unique requirements, finding it far more adaptable than larger systems like Agile.
01:13
Bringing accountability and compliance into the system with Unifize
In this video, Natalie discusses how Unifize has brought enhanced accountability and compliance into their system. She emphasizes the platform's role in ensuring that every change and process is properly documented and visible, which is critical for maintaining compliance. Natalie also highlights how Unifize's collaborative features enable better communication and task management, streamlining processes and preventing errors, thereby significantly improving operational efficiency and compliance adherence.
02:38
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.
03:46
Speed to market in Medtech is about empowering the quality team
Denis Machoka discusses the factors influencing speed to market in Medtech, focusing on the complexities of implementing a quality system. He underscores the detailed understanding of workflows, IT support needs, security considerations, and the potential high costs and maintenance of many systems, emphasizing their impact on the final product's cost.
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.
00:48
Handling audits made simple with Unifize
The video details how Unifize has simplified the audit process, making it easier to present and access required documentation. It demonstrates the platform's ability to consolidate information in a central location, significantly reducing the time and effort involved in audit preparation and execution.
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.
00:28
Resolving Out of Specs and getting the product to market faster with Unifize
In this detailed video, Mikala discusses how Unifize has streamlined the process of resolving out-of-specification (OOS) issues. She explains how the platform has reduced the time products are held in quarantine, from a month to mere hours, thereby preventing delays and backorders. Mikala highlights the cost savings and efficiency gains achieved through Unifize, showcasing its significant role in getting products to market faster while maintaining quality standards.
01:43
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.
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.
