Mikala shares her experience with streamlining change requests using Unifize. She talks about how the platform has simplified the process, improved tracking, and increased transparency. Mikala emphasizes the importance of efficient change management in maintaining product quality and compliance, and how Unifize has been instrumental in making these processes more manageable and effective.

Transcript

00:00 - 00:23
Change Requests, we use in all areas of the quality process. So for updating formulations, if we are adding new approved suppliers that would initiate a change request. Changes to our artwork, I know that our contract manufacturer uses change request to update work definitions, further batch records in our ERP system, Oracle.

00:23 - 00:35
Document revisions is very simple. Usually we trigger it through a change request because everything can be linked into the system in Unifize, initiating a change request, we can easily identify what type of change it is.

00:35 - 00:49
It'll then instruct us to link the necessary conversation type to it. We link that in and then it pushes out taskers for individuals to go through and update any of the linked document types that are within that change request.

00:49 - 00:53
And it kind of tracks each of these tasks. So as soon as they complete their part, they mark it as approved.

00:53 - 01:04
So the person who's responsible for making sure the change request was closed out could easily see from a bird's eye view. Like if everything's been done, once it's done, they can just approve it.

01:04 - 01:13
And the beauty with the linkages is I know previously to using Unifize, we had a lot of documents that carry a lot of the same data, but they're all in Excel or Word.

01:13 - 01:27
So you're going to each of these various document types and updating to make the same change. Whereas now you can make one change on the parent document and are automatically just changes it on everything. So reducing your time there to make the update.

01:27 - 01:38
There's a quick revision feature and then you mark it as current and again, the change request is already tied to it. So all the information as to why it was updated and the approval for that update is already tied to it.

01:38 - 01:43
And as soon as you click the request for approval and the individual approves it, it marks it as current.

01:43 - 01:47
And unless you have the necessary rights, no one else will ever see the other revisions.

How Unifize helped us streamline Change Requests

02:33

Getting engineering to adopt a new eQMS

02:53

Unifize QMS: Revolutionizing Quality Management for Compliance and Growth

01:23

How we use Unifize as an engineering system of record

03:10

Investigating deviations with Unifize

Change Requests and Orders

No items found.

Better Traceability

Revision Management

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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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