Investigating deviations with Unifize
The video explains Unifize's approach to managing deviations, emphasizing the platform's effectiveness in identifying, analyzing, and resolving discrepancies swiftly. It highlights how Unifize facilitates a comprehensive investigation process, contributing to higher standards of quality and compliance.
Transcript

00:00 - 00:43
You know, I think it really, right now for us where Unifize has shined in that respect is not so much on the raw material approval side. It has been on the corrective action side. The initial investigation, what went wrong and why, and especially if it involves external parties, third party contract manufacturers, other raw material vendors and suppliers, the ability for Unifize to be able to bring those outside parties into the conversation within your internal platform without a single person pinging emails back and forth, “Hey, this lot number didn't work. We found this and that one, this QC person over in this company said this, but they're cute to him. Their quality assurance manager said that.”



00:43 - 01:08
Trying to keep track of all those things and then being, having to be the point person that informs the rest of your internal team of what those conversations look like. Being able to have Unifize just be a natural part of that investigative process when you're trying to inform all the parties involved of what the current status is of an open deviation and why we think that occured, possible sources of the quality issue and so on, so forth.



01:08 - 01:37
That's where I've seen the immediate benefit. You know, when we have a quality issue that arises, say, with the third party contractor, I could just loop that their quality person directly in to the open carrot we have on Unifize itself. They can see the conversation we've had so far about potential sources of the quality issue in the first place, and then they could provide their feedback and then we can just update the counter form right there instead of waiting till weeks afterwards.



01:37 - 02:03
What sometimes happens is you can have these emails, you can have these conversations on the phone, you have these meetings with these external providers. But then when it comes time to actually updating your corrective action documentation, you have to go back and remember what you guys talked about. If you're not doing it right then, then it becomes much more difficult one week, two weeks, three weeks later on the process to be able to accurately recall and input all the potential solutions that you've discussed.



02:04 - 02:26
You're relying on memory and bits and pieces of information in different emails to piece together in order to recreate that information to put into your quality management system. And with Unifize, you don't you're not forced to do that, or the possibility of that occurring is reduced because you could just tap it in right there, as a conversation is happening.



02:26 - 02:36
When it comes to documentation and compliance, it's not a linear process where everyone is looking at the same thing at the same time all the time.



02:36 - 02:42
People are in their day to day workflow, are doing so many different things at once.



02:42 - 02:59
That information isn't synchronized in any way. So the more you're able to build in your compliance process, your documentation process into that day to day activity without increasing the resources required to execute the process, Unifize gives us the option to actually do that.



02:59 - 03:06
And right now it's really shown itself for us in being able to execute corrective actions for for the company.

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

02:04
Prioritising and getting things done faster with Unifize
In this video, Erica discusses her involvement in approval processes, particularly for finished good releases, using Unifize. She explains how Unifize allows her to prioritize tasks by marking finished goods as critical or urgent, which alerts the team to their importance. This feature, she notes, streamlines the approval process and reduces the likelihood of overlooking important tasks, a common issue with email communication. Erica highlights the efficiency of Unifize in managing time-sensitive requests, like needing an image, which could take hours through traditional methods. With Unifize, these tasks can be completed much faster, often within 15 to 30 minutes, greatly benefiting their fulfillment center's ability to respond to urgent shipping needs. This video showcases Unifize's effectiveness in expediting approval processes and improving overall operational efficiency.
04:27
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.
02:36
Reducing redundancies and getting things done faster with Unifize
In this video, Wilson highlights how Unifize has transformed their approach to product quality and development processes. By integrating Unifize early in the R&D phase, they've significantly enhanced discussions around quality, compliance, and consumer trends. This centralization has streamlined workflows, reduced the need for excessive meetings, and facilitated better communication across departments. The platform's ability to serve as a single repository for all relevant information has led to a notable improvement in efficiency and quality of life for the team, demonstrating Unifize's impact on eliminating redundancies and speeding up project completion.
03:20
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.
02:38
How Unifize makes audits easier
Jesse Kolstad highlights the revolutionary change Unifize brought to Biovation Labs' internal audit process. The platform facilitates direct capture and storage of visual evidence like photos, ensuring context and clarity. Drawing a contrast with past practices of manual note-taking and subsequent transcription, Jesse appreciates Unifize's real-time documentation that eliminates back-and-forth and enhances audit efficiency.
03:38
Change control with Unifize
Wilson explains the change control process within Unifize, highlighting how the platform facilitates smoother transitions and better communication. This approach ensures that all modifications are adequately reviewed, approved, and documented, contributing to continuous improvement and operational integrity.
01:08
Streamlining processes efficiently in a small company with Unifize
In this video, Wilson shares how Unifize revolutionized their small company by significantly enhancing visibility and accountability. Emphasizing it as a major quality of life improvement, they highlight the streamlined processes that now require less personnel involvement. The key efficiency gains were not in manpower reduction but in the quality of communication and process execution. Unifize eliminated the need for repetitive confirmations about document exchanges and validation steps, facilitating a smoother, more transparent workflow that benefitted product leaders, quality control, and their CTO.
01:42
What are the top reasons a product formulator should consider using Unifize
In this video, Natalie outlines the top reasons why a product formulator should consider using Unifize. She emphasizes the platform's ability to maintain and consolidate documentation effectively, ensuring that changes are documented and visible to all users. Natalie highlights how Unifize streamlines the ingredient review process and assists in the creation of master formulas. She underscores the disaster prevention aspect of Unifize, noting that without it, operations would be significantly set back, emphasizing its critical role in maintaining order and efficiency in their processes.
00:44
Under 24h response times from Unifize Customer Support
Dave Anderson praises the exceptional customer support of Unifize in this video, emphasizing the prompt and efficient response times to queries and issues. He shares his positive experiences, highlighting how Unifize’s support team consistently delivers solutions within hours, not days, ensuring minimal disruption to workflow. Dave's testimonial underlines the crucial role of Unifize’s customer service in enhancing operational efficiency and problem resolution, making it a valuable asset to any organization seeking to improve its process management.
01:28
A paradigm shift in managing quality collaboratively with Unifize
Wilson discusses the significant shift towards collaborative quality management introduced by Unifize. It emphasizes the enhanced cooperation between departments, leading to a more integrated and effective approach to quality control. The speaker credits Unifize for fostering a culture of shared responsibility and streamlined communication, which has been instrumental in improving their product's quality and compliance.
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.
01:54
Problems I faced with other eQMS that Unifize solved
Michael Hogan candidly shares his past frustrations with traditional QMS platforms. Recounting experiences where designs were sent into a seemingly endless void, only to receive feedback weeks later, he stresses the inefficiencies of such systems. For dynamic startups like Harmonic Bionics, where agility and promptness are paramount, a responsive and interactive QMS like Unifize became indispensable.
01:10
Reducing lot release time down to minutes with Unifize
Jesse Kolstad highlights how Unifize has dramatically curtailed lot release times at Biovation Labs. By optimizing the process, Unifize ensures lot releases are executed efficiently, reducing times to mere minutes.
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.
0:44
About Carol and her role at Efco
In this video, Carol Wilson introduces herself as a senior purchaser at Efco, a company specializing in concrete forming systems for various construction projects like bridges, houses, and parking garages. She shares insights into her role, where she oversees the procurement of all the steel required for Efco's forming systems. Carol highlights the scale of their operations, detailing the logistics of steel procurement, whether it's directly from mills in large quantities or through suppliers on a more regular basis, showcasing the complexity and importance of her role in the company's supply chain.
01:26
Making compliance a part of everyday workflow with Unifize
Wilson discusses how Unifize has seamlessly integrated compliance into daily workflows, transforming it from a cumbersome obligation to an effortless aspect of routine operations. This change has led to improved adherence to standards and regulations, with the speaker emphasizing the platform's role in making compliance natural and manageable.
01:17
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.
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.
00:47
Document revisions made simple with Unifize
Mikala, in this comprehensive video, explains how Unifize has simplified the process of document revisions. She highlights the platform's ability to streamline document management, making revisions more efficient and traceable. Mikala also discusses the impact of these capabilities on improving compliance, reducing errors, and enhancing overall operational efficiency. She emphasizes Unifize's role in facilitating better collaboration and communication, making it easier for teams to manage and revise documents in a cohesive and organized manner.
00:45
Fostering a culture of continuous improvement with Unifize
Mikala shares her experiences in fostering a culture of continuous improvement at her organization using Unifize. She details how the platform has been instrumental in promoting collaboration, streamlining processes, and encouraging proactive problem-solving. Mikala underscores the importance of Unifize in facilitating a more dynamic and responsive approach to quality management, which has been pivotal in driving continuous improvement and operational excellence.

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.