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.
Transcript

[00:00 - 00:12]
I'll use case recently they they found out in blending that they had added ten kilos too much of one ingredient to one of the batches and they @ me and my team and Unifize.



[00:12 - 00:31]
We generated the Non-Conformance because it was a Non-Conformance, but we were able to do the risk assessment, collaborate real time and give an answer to the blending tech out there on the floor as it was happening. And so, and sometimes the Non-Conformance escalates to the point where I need to involve the customer or the brand owner and I'm doing that as I'm finding it with, with them.



[00:31 - 00:46]
Just like I would collaborate on specs. If I find an issue, I can actually involve them in the decision. We do the risk assessment and rather than holding a product, segregating it and taking the time, we're making a decision at the shop floor.



[00:46 - 01:06]
Being able to real time collaborate about a Non-Conformance and again, an Out of Spec or even just we use what we've termed Observations. They may not be a problem, but they could be a leading indicator of a problem and collaborating with decisions right then and there. What used to take. All right, let's segregate it, let's set it aside.



[01:06 - 01:15]
Let's set up a meeting, let's set up a call. Let's talk. I'm talking to them as it's happening. What used to take days, weeks, sometimes months is seconds and minutes.

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Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
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Fewer meetings
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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.

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