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.
Transcript

00:00 - 00:04
Document revisions is very simple. Usually we trigger it through a change request.



00:04 - 00:18
So again, all of those conversation types that are required to be changed, we link to the change request and then we have an individual who's responsible for implementing it. So again, they know exactly just clicking on which items they need to update and just revise it.



00:18 - 00:28
There's a quick revision feature and then you mark it as current and again, the change request is already tied to it. So all the information as to why it was updated and the approval for that update is already tied to it.



00:28 - 00:34
And as soon as you click the request for approval and the individual approves it, it marks it as current.



00:34 - 00:38
And unless you have the necessary rights, no one else will ever see the other revisions.



00:38 - 00:43
So you're only able to look at what's most current in the system. So there is no confusion.

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

02:36
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.
05:21
Why Biovation moved from MasterControl to Unifize
Jesse Kolstad reminisces about his journey with quality management systems, notably his pivotal role in deploying MasterControl. As he navigates through the landscape of electronic documentation circa 2016, he highlights the challenges presented by platforms like SharePoint. While acknowledging MasterControl's early advantages, Jesse candidly critiques its user interface, shedding light on why a transition to Unifize became essential for Biovation Labs.
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.
00:48
How Unifize links raw materials to lots, formulas and finished products
Jesse Kolstad highlights Unifize's capability to seamlessly link raw materials to lots, formulas, and finished products. Providing a comprehensive view of the production process, Unifize ensures unparalleled traceability and accountability, enhancing production oversight at Biovation Labs.
05:38
Risk Management made easier on Unifize
Clarissa explains the criticality of risk management in the medical device sector, emphasizing patient safety. With Unifize, they've streamlined risk management, integrating their documentation and analysis seamlessly. The platform facilitates creating input-output matrices, linking design choices directly to user needs and demonstrating the impact on safety, thus simplifying compliance and ensuring a clear path to safe, effective medical solutions.
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.
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.
01:49
Why Slack is not the best system for managing quality
In this detailed video, Erica delves into the unique messaging and document management features of Unifize. She explains how Unifize facilitates specific conversation threads, such as for finished goods, artwork, or ingredients, allowing immediate access to relevant documents within these discussions. Erica contrasts this with Slack, where uploading and sharing documents is more cumbersome and lacks the context provided by Unifize's integrated system. She emphasizes how Unifize's layout enables users to quickly view dialogues and understand ongoing issues without extensive explanations. Additionally, Erica highlights Unifize's ability to hold users accountable and convey urgency in tasks, a feature she finds lacking in Slack. This video effectively showcases how Unifize streamlines communication and document management, enhancing productivity and clarity in workplace collaborations.
02:07
Centralizing master formula and reducing redundancies with Unifize
In this video, Mikala explains the benefits of using Unifize to centralize the master formula and reduce redundancies. She discusses how the platform has streamlined their formulation processes, improved accuracy, and reduced errors. Mikala highlights how this centralization has led to better resource management and efficiency in their operations, emphasizing the role of Unifize in enhancing productivity and reducing waste.
03:30
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.
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.
01:25
Taking faster decisions on Non-Conformances with Unifize
Jesse Kolstad underscores the agility Unifize brings to decision-making on non-conformances at Biovation Labs. The platform fosters rapid issue identification and enhances collaboration for swift resolutions, ensuring effective and timely corrective actions.
01:52
How Unifize helped us streamline Change Requests
Mikala shares her experience with streamlining change requests using Unifize. She talks about how the platform has simplified the process, improved tracking, and increased transparency. Mikala emphasizes the importance of efficient change management in maintaining product quality and compliance, and how Unifize has been instrumental in making these processes more manageable and effective.
01:33
How to make facing FDA audits easy
Clarissa Archer talks about the daunting experience of preparing for audits, especially from rigorous bodies like the FDA. She stresses the importance of a robust documentation system, serving as a "source of truth" during these audits. With Unifize, they could effortlessly produce, present, and recall documentation, simplifying the audit process and instilling confidence in their decisions and actions.
01:24
Why can't one use Excel or Pen & Paper to manage quality at a FDA regulated company
Natalie explains the inadequacy of using traditional methods like Excel or pen and paper for managing quality in an FDA-regulated company. She highlights the limitations of these methods in ensuring compliance, tracking changes, and maintaining data integrity. Natalie emphasizes the need for a more robust and specialized system like Unifize, which can handle the complexities and requirements of FDA regulations more effectively.
01:36
Closing the loop- Traceability and lot tracking using Unifize
Denis Machoka elucidates the intricate process of traceability and lot tracking at Harmonic Bionics, especially for their robotic devices. He details the meticulous tracing of parts, their consumption, and potential issues. Denis highlights how Unifize is instrumental in ensuring precise tracking and updating of materials consumed during the device development.
02:55
Using Unifize to simplify Approval processes
Clarissa explores the simplification of approval processes through Unifize in this engaging video. She narrates the challenges typically encountered in securing change order approvals and how Unifize's advanced features offer a solution. Clarissa is particularly impressed with the platform's flexibility in approval settings and its ability to integrate various processes and documents, which she credits for enhancing project management efficiency and decision-making clarity.
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.
01:43
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.
01:00
Enabling effortless information flow across the board with Unifize
Seth Bozman explores the challenges of articulating needs and implementing changes within Efco's operational procedures before Unifize. He reflects on the iterative process of customization and adaptation with Unifize, emphasizing its role in fostering a more efficient, error-proof workflow. Seth's story illustrates Unifize's capacity to streamline communication and process flow, ensuring that operational changes are seamlessly integrated and accurately reflected across the board.

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.