Change control with Unifize
Wilson explains the change control process within Unifize, highlighting how the platform facilitates smoother transitions and better communication. This approach ensures that all modifications are adequately reviewed, approved, and documented, contributing to continuous improvement and operational integrity.
Transcript

00:00 - 00:09
When you're operating a very manually intensive quality management system, change control was always a very big part of any obviously the fundamental aspect of any quality management system.



00:09 - 00:24
You need change control in order to ensure that whatever changes you're making to a process, a documented process, is being not just documented but also approved and in line with the requirements of your quality management system.



00:24 - 00:47
For us, utilizing Microsoft Word to try to make a functional change control system was always as the business grew and as more and more opportunities for improvement were identified, having to open up a template in Microsoft Word input all the changes into that document then find where the same SOP was.



00:47 - 00:57
I have net open tracking those changes in the SOP, trying to communicate what those changes actually looked like between the old and the new to the people with approval authority.



00:57 - 01:08
It became a big mess because you just hand say, department head here's the change control, here’s the list of 30 different changes are made to this operating process.



01:08 - 01:18
Here's the SOP document outlining all these changes with all these red lines and corrections that all throughout the document, you kind of have to figure it out.



01:18 - 01:27
Approver had to figure out what they were even looking at in the first place before they can even understand why the change was necessary and how can actually improve a process.



01:27 - 01:39
That was the way things worked before. And so because the process was so onerous, less and less people wanted to go through change control in order to document improvements to anything going with the core business process.



01:39 - 01:53
Now with Unifize, it makes it a lot easier because now the change on the Unifize platform, the change control, you could tie the doc to SOP from the document section module into the change control form itself.



01:53 - 02:09
So it's always tied together. So anytime you need to reference that when going back and forth, you can look at the correct revision of that document in relation to the change control and it's all there in a single place. It's not three, four, five, six, seven, several different files that you're trying to juggle in within a single change control.



02:09 - 02:31
So the fact that it's all tied in you can loop in everyone involved that gets affected by that change into the conversation next to the actual change control document and had the discussion right there and update the change control document as a conversation is occurring, and it makes the whole process significantly more efficient because you don't have to have the two or three requisite meetings to get people updated.



02:31 - 02:51
You don't have to explain to people why the change control is laid out in a certain way, why those changes, how those changes should be interpreted based on your writing style and your your understanding of the context. All that's all being done in the same place. And so change control now is just a lot more efficient and less of a headache for us because it's all right there.



02:51 - 02:59
And as a result, our team is more readily and willing to utilize a quality management system the way it's supposed to work.



02:59 - 03:07
Change control request sometimes just like any other document that requires an approval, sometimes can linger on because documents just fall through the cracks.



03:07 - 03:16
And we've had change control requests that would linger on for three to six months. Sometimes just because no one was actively managing that portion of the SOP.



03:16 - 03:34
And so we just remove that outcome from the quality management operation completely and have that reduced to just two weeks and having everyone informed about what was going on with that change control without having additional updates and meetings and emails has been a breath of fresh air for us.

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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