Building a GxP Training Matrix

Hi, everyone. My name is Kent Malmros, and I’m the senior director of Vault training at Veeva. Welcome to today’s session, building a GxP training matrix. Want to let you know I’m joined by my good friend, Kayla Brownell. She’s the global domain lead of Vault quality. And she and I have implemented a number of Vault training projects together. So after where I go through some of the key concepts, I’ll hand it off to her and she will bring everything to life by showing you a brief demonstration of the product.

Since we started developing Vault training, it’s been very critical to us at Veeva to improve the overall experience of developing and maintaining training records within a learning management system. And historically, learning management systems have made it very difficult to build, maintain, and deploy a true modernized role-based training matrix. And in a world where training is a critical part of the overall compliance efforts of a company, it’s even more important to ensure that you’re able to truly develop the right qualifications for your learners, get them to learners quickly, have them completed, and show those completions if an FDA inspection occurs, so that you can truly prove that you have prepared everyone in your company to do their job to the best of their ability.

There’s an impact if you’re unable to do that. In many respects, we of course worry about critical outcomes in healthcare. We want to ensure that we are building the best products possible. So having people ready to do their jobs is the most important piece of that equation. But also, if you’re unable to demonstrate compliance, the FDA will of course cite that as a quality problem. And it could result in warning letters or 483s. And that can have a dramatic impact on your business, including significant fines. So as you develop the right type of qualification set and apply them to a training matrix, historically, there’s been really a pyramid-based approach to ensuring the learning plan that employees are being delivered meets all the differing needs of an organization. And this can vary quite a bit from company to company, but ultimately you have corporate compliance, HR-driven assignments that have broad application. You have differing assignments depending on the nature of someone’s full-time or non full-time role in the organization.

And from there, you start to deviate based on what people’s functions are and what they do on a day-to-day basis at the department level, at a sub department level, and ultimately, an operational level. And with Vault training, we believe that it should be easy to ensure that you’re aligning the right content with the right people at the right time by having granular control over connecting those different really parts of that pyramid to an individual by defining what records you want to pretty much determine what qualifications should be at that operational level. And then associate them with an individual curriculum, learner role, department, location, and beyond. Now, this illustration demonstrates how we would do it in Vault training on a record by record basis. It’s really important to ensure that we can show you that pretty much in a real world example. So I’m going to hand it off to Kayla. She’ll walk you through some examples both on slides and then dive into the application and bring it to life.

Great. Thank you, Kent. So this slide here will show some of our, or an example of the different object records that you’ll find in the Vault. And those object records are all joined together. You have a learner, a learner role, curriculum, and various training requirements or types of training requirements. They’re joined together and they all work together with our automation to make sure that everything stays humming in the Vault nicely. And so this is an overview of all the different records you might have in your Vault, and I can show how they get joined together and how those different elements of the matrix are managed.

So here we have the person. So this is kind where, or everything starts the user, or a user is added to the Vault. And then the training administrator would probably come in and create their person record. So that person record is really what allows a user in a Vault to be part of the training program. So a new person, in this example, Leslie Learner, she started the company. We have to add her to some learner roles. So we’ve created her person record. And then we come down here and we see her learner roles. There’s a few for selection. So all of the learner roles that she may need to be added to would be listed there. And we just select the one that applies to her. Leslie is a quality auditor. So what that means is that Leslie’s learner role is linked to curricula.

So, that one learner role has three different curricula that it is associated to. And each of those curricula also will have the… they hold the training requirements or the documents that Leslie will need to train on. So I will show the corporate curriculum, which I think is maybe one of the best examples of how things can be a little bit flexible in your training matrix, because we have here our curriculum, it holds two different learner roles. So these are most of the learner roles in our Vault, which means that most or all of the learner roles that are in the Vault would be training on this particular curriculum, this corporate curriculum. So we have our training requirements. And these are the individual documents that Leslie and anyone else, of course, in those learner roles would be training on. And in those three, we have those three training requirements there. You’ll see they’re all Vault document training requirements.

These are going to be documents that are in the Vault, but there’s also other kinds. There’s classroom training requirements and external training requirements. They’re all managed in the same way when it comes to associating them with a curriculum, because they are all just training requirements. They are something that someone needs to train on and they’re all structured within that curriculum, and then they will receive training assignments accordingly. So in terms of what Leslie will see as a result of this. So all of these relationships have been established, meaning that Leslie is part of the quality auditor role. She will receive training assignments for all of the training requirements that are associated to these three curricula.

And so on her end, what that looks like is she would log in and she would see all of her training tasks. So if she was a current quality docs user, and she had been completing read and understand previous to this, it’s a very similar experience. You have your tasks list there and you open up the particular training assignment and it’s presenting the document in the Vault. And then the user just comes and completes training, renders a verdict, much like they did before, enter their electronic signature and password and complete their training.

They also maintain access to these things as long as they can still see the document. So they can reference past training assignments that they’ve received and reference those documents. And that’s up here in this training tab, they can see their training assignments. And they can always reference those. And then of course, if they are the manager of another person in the system, they can also see the training assignments for the people to whom are the people that report to them in their training assignments list. So that’s a little bit of extra visibility into the training program that may not normally be available.

So, how does this all tie together? And how did we get to what we just saw in the Vault? So here, this is an example of, let’s say current state, or maybe previous state that you would like to abandon. So this is an example of a lot of times of things that happen in a paper-based system, a paper-based training matrix where you have a curriculum that may just be based on the department, because someone in the department needs to train on, for instance, storage and distribution, GMP material movement. [inaudible 00:09:06] gets put in all, and gets put into the departmental curriculum, in this example, QA. And even though maybe some people in QA don’t need to train on it, they complete training because it’s part of the department. And then over there on the right, the same thing with CMC, right?

They have, computer systems validation, they train on it, but that might not be something that applies to every person in that department. But because it applies to someone, everyone trains on it. What you can do with a lot of the flexibility of the learner role, which is really the key part here. With the flexibility of the learner role, you can kind of break those departmental curricula into smaller chunks. Now, they may remain departmental, and that’s okay. It’s really just a matter of which learner roles are associated and how those things are structured. So in this example, we now have a little bit more a training matrix. It’s a little bit more tailored to the learner. So instead of it being an entire department, we have a quality auditor role. And that quality auditor would still be part of the corporate curriculum.

Of course, they’re part of the QA core. So that’s maybe not all QA SOPs, but just the core set of QA SOPs that Leslie is associated to. And then there’s also a curriculum for computer systems validation, which only has one trainer requirement, but the there’s always room for expansion. And there’s room for expansion in adding additional learner roles to that computer systems validation. It’s more of a topical curriculum, and you can have that flexibility to add additional learner roles as appropriate. And to kind of bring it all the way around, we also have the CMC person who was in the CMC department, but they are actually a CMC director. So they still have a lot of the things that Leslie had because, of course, corporate and QA core are going to be some of those high level ones. But there’s also now a supply chain curriculum where we have those two SOPs that QA didn’t really need to train on, but of course, CMC does, so now they’ve received that through the supply chain curriculum.

And then there’s the extra part there over there on the right hand side that managers and supervisors. So with that learner role where this particular person has a CMC director learner role, which is somewhat tied to their title. It may not be, it may just be a generic role. But either way, they also are, in that capacity, are a manager or a supervisor. And so there are manager and supervisors-specific trainings, which is part of that management curriculum. And then those documents, the annual performance review, guidance maybe, or PTO review and approval policy can be included in their training matrix because that is something that they train on topically. And so that allows a lot more flexibility and will make sure that everyone is trained on the right thing at the right time, instead of getting too much or not enough training.