Content Library

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.

00:00 - 00:19
If you have five products and that's all that your company is making potentially is manageable with an Excel spreadsheet, as soon as you start scaling up or you're making changes to those five products, let's just say you have 20 products, 30, 40, 50, 60, and you're trying to manage everything.



00:19 - 00:23
You know, when I first started here, we had this amount of products.



00:23 - 00:27
Was it manageable to do it the way we were without any system? Yes.



00:27 - 00:44
But as soon as you start finding out that documentation has changed and then you're trying to where are you saving that in the folder? How does everybody know that it's changed? No alerts are going out unless you're sending an email and no one wants a million emails.



00:44 - 00:52
I mean, like we've grown so much, it would be impossible to do everything on paper without a quality management system.



00:52 - 01:11
If we didn't have Unifize it would create a disaster. We would be back to square one with finding different ingredients, reviewing the documentation, figuring out how ingredients are different or similar to each other, We would have to obtain all of that information, again.



01:11 - 01:20
I can't imagine. I think it would be catastrophic. We would have to start from zero with so many different things.

Why can't one use Excel or Pen & Paper to manage quality at a FDA regulated company

Customers

Denis's experience with Unifize: Revolutionizing quality assurance systems

Quality expert Denis details his transformative journey with Unifize. He praises its efficient design, user-centric approach, and the system's ability to streamline data handling and accelerate time to market.

Customers

Harmonic Bionics and Unifize: A seamless transition to regulatory compliance

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.

Customers

Engineering efficiency with Unifize: Michael Hogan's insights from Harmonic Bionics

Mechanical Engineer Michael Hogan elaborates on how the integration of Unifize at Harmonic Bionics has streamlined his engineering processes, promoting transparency and rapid turnaround in the medical device domain.

Customers

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.

A quote from Tedd Carr
Customers

How a quality veteran from boosted issue closure time by 75% within the first month

Tedd Carr from The Will-Burt Company discusses overcoming their diverse and complex quality challenges across various sectors with Unifize. By consolidating five systems into one, they achieved clear accountability and reduced issue closure from months to days, demonstrating significant efficiency gains and faster decision-making in their quality processes.