Content Library

Jesse Kolstad emphasizes the importance of traceability in regulated industries. At Biovation Labs, Unifize connects finished products, ingredients, formulae, and packaging artwork. Its collaborative features unify workflows, replacing scattered emails and calls with real-time discussions, streamlining efficiency and ensuring seamless process integration.

Join the discussion

0 comments

Active Here: 0
Be the first to leave a comment.
Loading
Someone is typing
No Name
This is the actual comment. It's can be long or short. And must contain only text information.
Edited
Your comment will appear once approved by a moderator.
No Name
Set
This is the actual comment. It's can be long or short. And must contain only text information.
Edited
Your reply will appear once approved by a moderator.
Load More
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Load More
Transcript

[00:00 - 00:22]
So within a regulated industry, I need to have traceability to from finished product, as I said, to the ingredients that went into it to even the formula and Unifize allows me through its connectivity, through its collaboration at each and every level to say I have ingredients. As we said, I can approve the specs. Those specs go into a formula, the formulas go into a tablet or capsule.



[00:22 - 00:47]
Those go into a bottle. That bottle has artwork at each and every juncture there. There has been collaboration, simultaneous, something that used to be discrete, unique emails and calls and processes. They're all happening all at once and they come together the way they should in a finished product because that's what we make is a finished product and being able to collaborate with all the right individuals simultaneously because not everybody needs to be involved in everything.



[00:47 - 01:10]
And so this real time aspect of while they're over here talking about ingredients, I'm over here talking about artwork, we're talking about finalizing the formula. It all comes together. And then each Lot of that approved formula with its approved specs and its approved approved ingredients is we manufacture it, we test it, we release it, and then I can go backwards from that Lot.



[01:10 - 01:21]
As I said, just like I could go out there and scan that QR code on an ingredient. I my finished product palettes have that same of a similar QR code on it. I can scan that and walk all the way backwards to that ingredient.



[01:21 - 01:49]
There isn’t aspect of this of our product that isn't touched by Unifize. If you look at the tablets in here, the ingredients that went into it, the formula that made it, the parameters they use to dosage it, the specs for this bottle, the specs for this lid, the approvals and everything that went into it that culminates in this on your shelf Unifize has a and moreover a complaint at the bottom after the fact is Unifize is every has its hand in every piece of this



[01:49 - 02:15]
It's my sincere hope. In the future I can actually use my inkjet printers during production to print a QR code per Lot on the bottom of the bottle so that I could walk into a store where we sell a product that we've made and scan that QR code and I'm end to end cradle to grave visibility, traceability of everything I need to know about that product because nobody else is doing that and Unifize has absolutely given us the ability.



[02:15 - 02:18]
It's realistic. I could do that probably soon,

Managing the product lifecycle and ensuring efficient traceability with Unifize

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

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.

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.