Raw material validation with Unifize
The video delves into how Unifize streamlines the raw material validation process, enhancing efficiency and ensuring compliance. It highlights the platform's role in simplifying complex validation procedures, thereby facilitating a more robust quality control framework.
Transcript

00:00 - 00:08
So we're still developing the processes in Unifize for the entire new product development lifecycle.



00:08 - 00:29
That's something that is on the docket that we want to put into place. Right now, the way we're using Unifize, it's a part of that entire lifecycle process. The part it's relevant to is new raw material validation section eventually it's part of the finished good quality control section.



00:29 - 01:04
We have those two main processes on board right now and being used in Unifize, and those are different stages in that product development process. And so just having Unifize be the central hub for compiling new raw material validation information has been very helpful to us because in the past, you would have a Microsoft Word document or a PDF and we had a checklist that we had created, but no one was ever looking at the checklist at the exact same time, and no one was updating that checklist consistently.



01:04 - 01:23
And any time there were approvals built into that checklist, it required, again, emails, verbal reminders to get those approvals checked off. And every time that you moved to a different stage, you would need to have meetings just to keep everyone up to date about what was going on up to that point in the validation of that raw material.



01:23 - 01:31
Even just beginning stages of validating raw material involves qualifying vendors, auditing them, sending out questionnaires.



01:31 - 01:49
The compiling of all the requisite regulatory and compliance information, the different tasks involved in executing that process. We're not really working in parallel with each other. They're just working intermittently. And as one person we've recalled that they had finished this one point stage.



01:49 - 01:54
It was incumbent to them now to inform everyone else it was time to move the process along. So it's very cumbersome.



01:54 - 02:19
So being able to recreate that process in Unifize and build in the approvals, having Unifize be a repository for all that regulatory and documentation, compliance documentation has made that process a lot easier because someone in R&D can finish a certain stage of validation because we go through many stages of raw material validation to ensure that whatever is going into our products is safe and effective.



02:19 - 02:42
And so we never say someone in R&D would finish a particular stage, it would need a review and check by quality assurance or the CTO. You know, all it would take is a quick email, a sorry, a quick notification and an automation within Unifize to make that person the owner of that process and suddenly he has the requisite visibility needed to get their approval through.



02:42 - 03:01
And everyone knows when they look at that process in Unifize exactly where everything's and exactly what stage are they in, what else needs to be done. So that has been really valuable to us to be able to push raw material validations through and ensure that every single I and every T is dotted, crossed and vice versa.

Related Videos

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

02:27
Establishing Accountability and taking faster decisions with Unifize
Tedd Carr expresses how Unifize transformed The Will-Burt Company's approach to quality management. The previous system, a chaotic mix of emails and ad-hoc methods, lacked clear ownership and accountability, leading to prolonged issue resolution times. With Unifize, they have consolidated five systems into one, establishing defined accountability and enabling rapid task completion—what once took weeks or months now concludes in days, significantly optimizing their operational efficiency.
Watch Video
01:42
About Dave
In this video, Dave Anderson, Quality Assurance Manager at Efco with 20 years of tenure, shares his journey from the shop floor to senior supervisory roles before stepping into quality assurance. With a passion for continuous improvement and an improvement-minded approach, Dave emphasizes the importance of striving for perfection in quality management. His experience highlights the value of shop floor knowledge in identifying root causes and implementing sustainable solutions, underscoring the significant impact of hands-on experience in quality roles.
Watch Video
01:13
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.
Watch Video
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.
Watch Video
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.
Watch Video
00:46
Adopting a new system in an institutional knowledge based shop floor
Dave Anderson shares insights on the challenges and successes of implementing Unifize in a shop floor rich with institutional knowledge. He discusses the initial resistance to change and the skepticism towards adopting new systems. However, Dave highlights the transformative moment when team members begin to use Unifize, noting the ease and efficiency it brings to processes previously burdened by paperwork. This video illustrates the journey from hesitation to acceptance, showcasing the significant improvements in workflow and productivity with the adoption of digital solutions.
Watch Video
05:04
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.
Watch Video
01:29
Auto generating reports with formulas using Unifize
Seth Bozman highlights the transformative impact of Unifize's formulas and auto-generator features on Efco's cost analysis and quality reporting. He shares how these features have eliminated the need for manual data entry into external databases, significantly reducing the time spent on generating quality reports. This video showcases Unifize's capability to automatically calculate costs, offering Efco a streamlined, efficient approach to tracking and analyzing scrap and rework data.
Watch Video
01:23
Why Unifize was such a breath of fresh air in the quality management world
This video highlights Unifize's innovative impact on the quality management sector, praising its user-friendly interface, flexibility, and comprehensive features. The speaker describes how Unifize stands out from traditional QMS solutions by encouraging proactive engagement and simplifying complex processes, making quality management more accessible and effective.
Watch Video
01:34
How Biovation uses Unifize to create traceability and take better decisions
In this video, Jesse Kolstad of Biovation Labs highlights how Unifize is instrumental in managing ingredient specifications, formulating products, and monitoring trends. He underscores the platform's ability to seamlessly interconnect various stages of the production process, from ingredients to finished products, allowing for enhanced traceability and informed decision-making.
Watch Video
00:56
What happens when QA people develop software
This video offers insights into the unique perspective brought to software development by quality assurance professionals. It suggests that a focus on collaboration and flexibility, typically lacking in traditional QMS software, is essential for creating a system that truly meets the needs of all users. The speaker reflects on the importance of designing quality management tools that are not only about data storage but also about enhancing the user experience and operational efficiency.
Watch Video
01:27
Why Slack and Teams can't replace a collaborative eQMS
In this insightful video, Mikala explains why Slack and Microsoft Teams cannot replace a collaborative eQMS like Unifize. She discusses the limitations of these platforms in handling quality management processes, emphasizing their lack of specialized features for tracking, auditing, and maintaining compliance. Mikala highlights how Unifize offers a more integrated and comprehensive solution, tailored to meet the specific needs of quality management, thereby enhancing efficiency and ensuring compliance.
Watch Video
04:59
How Denis builds a quality culture in MedTech companies
Denis Machoka, a Six Sigma black belt, highlights his transformative approach to Medtech companies. He shares insights on assessing an organization's current state and vision, the critical role of communication in building a quality culture, and the essential tools to foster knowledge and improvement.
Watch Video
00:44
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.
Watch Video
05:02
How Applechem approaches product development and commercialization
Applechem's approach to product development and commercialization is detailed, showcasing their emphasis on rigorous research, customer collaboration, and market analysis. The process underscores a strategic method to ensure that new products are both innovative and aligned with market needs.
Watch Video
02:42
Why you can't use Slack and Teams to build life science products
In this video, quality leaders from a popular nutraceutical manufacturer, Adaptive Health share their experience on using communication tools like Slack and Microsoft Teams to manage quality. They emphasise on the fact that these tools disconnect the collaboration from the data, leading to greater redundancies affecting their product launch process. They also share their experience on using Unifize to manage their quality processes end-to-end, and how it improved their collaboration and data management tremendously not just within their organisation, but across their partner organisations as well. Watch this video to know more about why Slack and Teams cannot replace a powerful collaborative eQMS solution like Unifize.
Watch Video
02:23
Get to market faster by enabling agility and overcoming fear
Denis Machoka emphasizes the importance of overcoming the inherent fear of new technologies in the quest for compliance. He advocates for education to bridge the gap between rapid societal advancements and slower professional tech adaptations, stressing the need for agility in today's fast-paced world.
Watch Video
01:24
What is the challenge with managing a QMS actively
In this video, Wilson delves into the challenges of actively managing a Quality Management System (QMS). They reveal how manual processes, over the years, made the QMS cumbersome, deterring the team from utilizing it fully for new product development and quality control. Highlighting a shift towards an electronic QMS to mitigate these issues, the speaker underscores the importance of a QMS in improving business operations, controlling quality output, and fostering continuous improvement, stressing that an efficient QMS is vital for operational success.
Watch Video
00:59
They key to configurability- make it simple & easy
Denis Machoka extols the straightforward configurability of Unifize, contrasting it with the complexities of other systems. He appreciates its pre-configured design, likening it to object programming. Denis believes Unifize's inherent simplicity is testament to its creators' deep industry understanding and their aim to simplify user experience.
Watch Video
01:23
Quantifying things that were previously deemed impossible
In this video, Seth Bozman from Efco shares his transformative experience with Unifize, emphasizing its critical role in revolutionizing how they track and manage work orders, particularly in quantifying costs of specials and parts in a manner previously unachievable. He highlights Unifize's impact on making their process more efficient, allowing for a significant increase in productivity by enabling a more precise cost analysis and facilitating an enhanced focus on floor operations. Seth's testimony showcases the power of Unifize in streamlining operations, improving data accuracy, and supporting proactive decision-making at Efco.
Watch Video

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.