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Jesse Kolstad highlights the complexities of document control in regulated industries, emphasizing the need for more than just maintaining master copies. With Unifize, he ensures the organization is well-trained and aligned with the latest documents and SOPs, promoting compliance and operational efficiency.
Transcript

[00:00 - 00:19]
So with regard to document control, which is something that's required in the regulations and it's something that's ubiquitous to every quality group across the board in this industry. And actually any regulated industry for the most part, in my experience from a neutral infant formula, I mean, they all have their own set of guidelines and controls.



[00:19 - 00:49]
I think it's even I sort of have them on right. And a lot of people think doc control is quite literally: I have a signed, approved master copy and I put it in a file cabinet and I control it then. And every and I mean every quality management system bolt on to an inventory management system. I've worked with LIMS systems they, they all approach you first and foremost as a doc controller, which I think is a it's shortsighted because MasterControl did this.



[00:49 - 01:09]
They'll come at you and say, we can store your documents, will, so can a file cabinet, so can an email server. So I mean, and people get romantic about that and they and they like that and they said this is what I need. I need to be able to store it electronically. What do you do is that that powerful and Unifize gave me that.



[01:09 - 01:13]
I mean right away I was able to I have all my SOPs. I digitally signed them.



[01:13 - 01:23]
But Unifize give me the ability to go one step further because when you have aStandard Operating Procedure, your SOPs, well, those you don't have them just to have them because the regulations say you need them. They're supposed to be yourStandard Operating Procedure.



[01:23 - 01:54]
Right. But that requires training. So somebody needs to understand how to do their job via the Standard Operating Procedure. That's how they operate. And who needs that training? Well, there's different job descriptions across the company. You have your operators, you have your maintenance techs, quality techs, etc., etc.. So who needs what training from that SOP and Unifize allowed me to start my SOP, build my training, attach that to all the jobs that's that it's meant for.



[01:54 - 02:13]
And then I went the last step was okay, what employees are in those jobs? And so day one employee start and their training is right in front of them and they have one button access to the reference documents, which is helping me to build that sort of Holy Grail with regard to quality compliance and training of having them use our SOPs



[02:13 - 02:18]
Because there our SOPs, not because we wrote them.

How Unifize ensures everyone is trained on the right version of documents and SOPs

Unifize Results

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Speed to compliance
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Faster time-to-market
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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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