Content Library

In this video, Clarissa shares how her team slashed implementation timelines from weeks to days using Unifize’s AI—without compromising on compliance. Discover how AI-generated suggestions, human oversight, and smart documentation accelerated their journey to FDA readiness in just four weeks.

00:00 - 00:27
A lot of these things take years to happen, whereas with Unifize, we were able to get it done with about four weeks in order to start utilizing our change controls and our documentation controls. These are suggestions. And the human at the end of the day is saying, yes, these are correct with what I would say or no or let me tweak it.



00:27 - 00:52
And so I think that's where you can show like, no, you don't just click a button say Suggest AI and then you move on from that process. You look at the suggestions, approve what's being done, and you sign off on it. You know what I mean? Like, I think that's part of what you can show an auditor and say, yes, AI may have generated this, but I verified each of the outputs and confirmed that that is correct.



00:52 - 01:12
And it would take three weeks to implement from beginning to end. Now it can take a couple of days. That really helped with the adoption and the understanding that yes, we can still move fast, but we need to move fast in a compliant way.

How fast can you achieve Medical Device compliance with AI

01:27
How approvals in Unifize helped us collaborate across organizations and get things turned around faster
02:55
Using Unifize to simplify Approval processes
01:12
How fast can you achieve Medical Device compliance with AI
01:04
How the Unifize team helped build our customisations faster
Change Control
Document Management
No items found.
No items found.
Artificial Intelligence (AI)
No items found.
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.

View Case Study
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.

View Case Study