Value of Unified Training

Hi everyone. My name is Kent Malmros. And I’m the senior director of Vault Training at Veeva. Welcome to today’s session, the value of unified training. I’m joined by my good friend, Kyle Boelter, who is a senior solution consultant for Vault Quality. After I have spoken a little bit about the value of unified training, I’ll be handing it off to him for some demonstration.

So one of the key aspects of the Vault Training product, and one of the key benefits that we have built into the application, is that it is part of a Unified Quality Suite. And, for us, that is a critical aspect of the strategic component of the product. Ultimately, we want you to have the ability to combine all of your quality processes in one place. And we know training is a critical piece of that equation. And when you think about how training works as part of a unified document management and learning management environment, you have the power of automating, retraining assignments, when a document goes through a lifecycle state change and it up versions. Similarly, you have the chance to combine training and the ability to assign training to learners as part of a quality action or event. So if you consider how critical it is to leverage training when you are going through, for example, a CAPA workflow, that’s something that historically requires integration.

And if you integrate two systems and you also require paper or manual processes, you’re not able to genuinely deliver training or frankly make changes to critical training materials in the flow of work. And you want to add learning to the flow of your everyday processes. And this is something that we have a fantastic example of in our everyday life. Think about the evolution of GPS and how you used to leverage a math and you were unable to get your status in a particular location or geography in the flow of driving. You had to stop and look at an Atlas, but now you’re able to, through your phone, have the map continually provide new data and new context and tell you where you need to go as you change your coordinates.

And similarly, if you think about how training should work as part of an overarching change control in your quality system, that then includes a document change control, ultimately of a critical document up versions, you want to ensure that qualification based assignments automatically re-trigger to the right learners so that you can get them qualified or requalified very quickly. And of course, that process takes place as part of typically, maybe a deviation that turns into some type of corrective action. And you can see that with, while training as part of Unified Quality Suite, it becomes very possible to do this. And also importantly, possible to do this with modern learning techniques.

So one of the key attributes of QualityDocs is that we’re managing documents that include various modalities. An example is video and video is very commonly used as part of a micro learning approach to a training plan. So if you’re developing training in the flow of work and you want micro learning to be a reinforcement tool, as part of maybe that corrective action approach, this is a scenario where unified systems provide an opportunity to realize that benefit. So now I’m going to transition to Kyle so he can show you how this comes to life as part of Vault Training in Unified Quality Suite.

Thanks Kent. An important Unified Quality Suite benefit is at all of your tasks across the Quality Suite or QualityDocs, QMS and training are in one location for one stop consumption. This is in addition to receiving these tasks in your email inbox with actionable links that drive you directly towards those tasks for completion. All of our tasks have color indicators. You’ll note that the ones that are in green are not due yet. Any tasks that you see in amber or orange are due within five days. And any task that you see in red are overdue.

Our consumer web experience allows users to filter their training task quickly and efficiently. On the left hand side, you’ll see that I can filter my training task, and I go directly to my training. When you look at our training assignments, you’ll see that from left to right we give you the task name, we’ll give you the training assignment type, we can also provide you with a learner’s manager. If there is a quiz associated with this training assignment, you’ll see a quiz in a quiz column, and then you have a direct assignment, which is very important and we’ll come back to that in a little bit.

Then also you’ll see that there’s other columns for training links, for due dates, et cetera. One of the important aspects that you’ll notice is that users are able to personalize this view. One of the things that you’ll notice is that we have three different types of training assignment types here. You’ll notice that we have Vault document training, that we have external training assignments, that we also have SCORM training. And in addition to those three, we also have classroom training as well that’s available. Today we’re going to focus on a document training. And here we’re going to select our manufacturing review. We have our SOP for manufacturing review. We’ll be able to go in, we’ll be able to complete the read and understood on this particular document. And then we can complete our training. Here we’re going to sign off on our read and understood, and we’ll apply our 21 CFR Part 11 credentials, and we will complete that task.

Now that we’ve completed that task for the user by leveraging the cohesive of the Unified Quality Suite through QMS event, we realize some time later that employee did not execute that SOP correctly. So as a result, we can go to a deviation. And with that particular deviation, we find out through a CAPA that we can assign a new training requirement specifically for that user. We do not have to deliver the training requirements to everybody that’s part of the learner role that’s attached to that curriculum, because of course we have one individual, one learner who do not follow that particular SOP. And that’s the beauty of the Unified Quality Suite. So you see here that once I’m in the deviation, I can go to that CAPA that’s been created from that deviation. And then within that CAPA, you’ll notice that I have a training request.

And with that training request, we want to provide that single employee with some simple mental training. And if I select that, you notice that’s in a created state. And the minute that I make that issued for that particular training requirement, that training assignment is going to be made for that learner. You see that’s assigned to them immediately. Okay. Now, before we go back and actually complete that task as part of the retraining for that employee, let’s talk about a second scenario or second use case. If we go back to that CAPA, let’s suppose that the employee did follow that SOP correctly. And let’s just suppose that maybe there were some steps missing with that particular SOP and we needed to update the SOP. Again, because us, we have the Unified Quality Suite, what you’ll notice is that we can create a change control from that CAPA.

And with that change control, that change control can drive us directly to a document change control. And with that document change control, the beauty of the system is that if that particular document is part of a curriculum that’s already been delivered to a learner group, the system automatically identifies that learner group and will reissue that training to those learners with a new version of that document. So in this particular use case, we have gone from a deviation to a CAPA, to a QMS change control, to a document change control, to a training requirement update for your learners. So that’s the second use case. But if we go back and we complete the first use case, again, we went from a deviation to a CAPA, to a training requirement. I’ll go to my homepage, I’ll filter all my training assignments again. And once I do that, you’ll see that that SOP for manufacturing review is now available for this learner that did not execute this SOP correctly in the first place.

So once we select that, you’ll notice that as a direct assignment request, this employee can complete the training. So here we can sign off on this and will add our 21 CFR Part 11 credentials. Now that training requirement has been completed, it’ll be added to the audit trail, and you’ll be able to have that in your reports as well. Now, with Vault, what we provide for you is a very robust, flexible, and configurable reporting engine that allows your training administrators and managers to efficiently monitor training compliance of your organization, departments and employees, as well as Unified Quality Suite application relationships. So if we take a look at that and we go to our dashboards, you’ll see that we have a training dashboard.

And within that training dashboard, we have a report that really ties together those relationships of the Unified Quality Suite. So here you have the quality event with the CAPA and direct assignment request. In addition to that, you’re going to see the user or the learner that direct assignment request was made to. So this gives us the ability to track the compliance across your organization. In addition, these reports can be delivered to you on the frequency that you want. So they can be delivered to you daily, weekly, or monthly so that you don’t have to come looking for them, whatever the frequency is that you want. So here, you’ll see from left to right, that we have that quality event, the title of that quality event, whether it’s a deviation, whether it’s a change control, et cetera. You also see the related CAPA, the direct assignment request, and then that actual learner. And all of these are actionable links that will drive you towards that particular quality event, that CAPA or that direct assignment request we have for learning.