Investigating deviations with Unifize
The video explains Unifize's approach to managing deviations, emphasizing the platform's effectiveness in identifying, analyzing, and resolving discrepancies swiftly. It highlights how Unifize facilitates a comprehensive investigation process, contributing to higher standards of quality and compliance.
Transcript

00:00 - 00:43
You know, I think it really, right now for us where Unifize has shined in that respect is not so much on the raw material approval side. It has been on the corrective action side. The initial investigation, what went wrong and why, and especially if it involves external parties, third party contract manufacturers, other raw material vendors and suppliers, the ability for Unifize to be able to bring those outside parties into the conversation within your internal platform without a single person pinging emails back and forth, “Hey, this lot number didn't work. We found this and that one, this QC person over in this company said this, but they're cute to him. Their quality assurance manager said that.”



00:43 - 01:08
Trying to keep track of all those things and then being, having to be the point person that informs the rest of your internal team of what those conversations look like. Being able to have Unifize just be a natural part of that investigative process when you're trying to inform all the parties involved of what the current status is of an open deviation and why we think that occured, possible sources of the quality issue and so on, so forth.



01:08 - 01:37
That's where I've seen the immediate benefit. You know, when we have a quality issue that arises, say, with the third party contractor, I could just loop that their quality person directly in to the open carrot we have on Unifize itself. They can see the conversation we've had so far about potential sources of the quality issue in the first place, and then they could provide their feedback and then we can just update the counter form right there instead of waiting till weeks afterwards.



01:37 - 02:03
What sometimes happens is you can have these emails, you can have these conversations on the phone, you have these meetings with these external providers. But then when it comes time to actually updating your corrective action documentation, you have to go back and remember what you guys talked about. If you're not doing it right then, then it becomes much more difficult one week, two weeks, three weeks later on the process to be able to accurately recall and input all the potential solutions that you've discussed.



02:04 - 02:26
You're relying on memory and bits and pieces of information in different emails to piece together in order to recreate that information to put into your quality management system. And with Unifize, you don't you're not forced to do that, or the possibility of that occurring is reduced because you could just tap it in right there, as a conversation is happening.



02:26 - 02:36
When it comes to documentation and compliance, it's not a linear process where everyone is looking at the same thing at the same time all the time.



02:36 - 02:42
People are in their day to day workflow, are doing so many different things at once.



02:42 - 02:59
That information isn't synchronized in any way. So the more you're able to build in your compliance process, your documentation process into that day to day activity without increasing the resources required to execute the process, Unifize gives us the option to actually do that.



02:59 - 03:06
And right now it's really shown itself for us in being able to execute corrective actions for for the company.

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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