Raw material validation with Unifize
The video delves into how Unifize streamlines the raw material validation process, enhancing efficiency and ensuring compliance. It highlights the platform's role in simplifying complex validation procedures, thereby facilitating a more robust quality control framework.
Transcript

00:00 - 00:08
So we're still developing the processes in Unifize for the entire new product development lifecycle.



00:08 - 00:29
That's something that is on the docket that we want to put into place. Right now, the way we're using Unifize, it's a part of that entire lifecycle process. The part it's relevant to is new raw material validation section eventually it's part of the finished good quality control section.



00:29 - 01:04
We have those two main processes on board right now and being used in Unifize, and those are different stages in that product development process. And so just having Unifize be the central hub for compiling new raw material validation information has been very helpful to us because in the past, you would have a Microsoft Word document or a PDF and we had a checklist that we had created, but no one was ever looking at the checklist at the exact same time, and no one was updating that checklist consistently.



01:04 - 01:23
And any time there were approvals built into that checklist, it required, again, emails, verbal reminders to get those approvals checked off. And every time that you moved to a different stage, you would need to have meetings just to keep everyone up to date about what was going on up to that point in the validation of that raw material.



01:23 - 01:31
Even just beginning stages of validating raw material involves qualifying vendors, auditing them, sending out questionnaires.



01:31 - 01:49
The compiling of all the requisite regulatory and compliance information, the different tasks involved in executing that process. We're not really working in parallel with each other. They're just working intermittently. And as one person we've recalled that they had finished this one point stage.



01:49 - 01:54
It was incumbent to them now to inform everyone else it was time to move the process along. So it's very cumbersome.



01:54 - 02:19
So being able to recreate that process in Unifize and build in the approvals, having Unifize be a repository for all that regulatory and documentation, compliance documentation has made that process a lot easier because someone in R&D can finish a certain stage of validation because we go through many stages of raw material validation to ensure that whatever is going into our products is safe and effective.



02:19 - 02:42
And so we never say someone in R&D would finish a particular stage, it would need a review and check by quality assurance or the CTO. You know, all it would take is a quick email, a sorry, a quick notification and an automation within Unifize to make that person the owner of that process and suddenly he has the requisite visibility needed to get their approval through.



02:42 - 03:01
And everyone knows when they look at that process in Unifize exactly where everything's and exactly what stage are they in, what else needs to be done. So that has been really valuable to us to be able to push raw material validations through and ensure that every single I and every T is dotted, crossed and vice versa.

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.

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