To watch the on-demand webinar associated with this presentation, please visit: https://go.veeva.com/closed-loop-training-compliance-registration
Efficiently managing GxP training content through a unified learning management system (LMS) is crucial to meet global compliance for life sciences companies. But legacy approaches and disparate technologies prevent them from doing so.
Today, many biopharma companies use one system to manage training and the other to manage standard operating procedures (SOPs), policies, work instructions, and other critical documents. These disconnected environments require extensive configuration and integration, reducing compliance visibility, and creating a barrier between content creation and consumption.
In this webinar, John Constantine, SVP of Talent Solutions at Orchestrall, and Kent Malmros, Senior Director of Vault Training at Veeva Systems, will discuss why many life sciences companies are modernizing learning management with a unified training platform. They will share how unifying document management and training in a single platform ensures the traceability of training materials from creation to consumption, enabling closed-loop compliance.
By attending this webinar, you will learn:
How to address common challenges in building an effective GxP training program
Best practices of creating an enterprise-wide learning strategy
How a unified GxP training environment delivers better training and quality outcomes
Who Will Benefit
Director/Manager of Quality Training
Compliance Training Manager/Director
Compliance Policy and Training, Manager/Director
Director/Manager, QA Training
Document Control and Training Manager
VP/Director of Quality and Compliance (QA or QC), Quality Systems
VP/Director of Information Technology, Quality Management Systems, Quality Systems
VP/Director Clinical Operations
Kent to intro himself, throw to John for his intro.
Kent
Kent
The perception of quality, GXP and compliance training is that there are multiple, separated process that all come together in a single technology.
On one-hand, it’s critical to manage the development of training content – but that’s done in varying systems.
It’s also important to develop critical training plans. That happens using other process.
The desire end goal is tracking qualifications. They need to be demonstrable as a data set that can be shown to inspectors or auditors.
The perception is that the activities that go into developing compliance training, as a foundation to enterprise training strategy… and the required data that come out of it, converge is ONE core technology…
An LMS
This is where the content, users, training plans aligned to role-based qualifications all come together so assignments can be made and monitored.
But this is a perception, not a reality. All of the efforts that that go into the records that you upload to a an LMS, and all of the data and how you want USE it… coming out of an LMS, are part of a training development loop. If that loop isn’t closed, training compliance suffers, and also, your organization will get stuck in the tactical hand-to-hand combat that limits the ability to invest man hours into making training strategic.
Our goal today, is to change the way you think about that loop, give you some tools to try and close it, instead of leaving it broken, and buy time to invest in your enterprise training strategy.
Transition to John
So, John, let’s break down that reality in a bit more detail…
But first, maybe we can get the audience to tell us a little bit about what they are doing today.
John / Kent discuss to setup
Do you want to define learning strategy for the audience as they answer this question?
John
John
John
John transition to Kent
Kent
So now that understand what goes into the strategy, let’s talk about how the tactics work. Typically, we can think about breaking this up into four discreet buckets of activity.
The first step is to create source content. This requires SMEs, and job-level expert, regulatory experts, etc. More advanced organizations include instructional designers in this process. The most often happens in WORD, and the documents have lifecycles, as well as review workflows. The tools required for this are Offfce, Email, Fileshares, Doc Management Systems and sometimes project management tools.
Once content is authored, reviewed and approved, it’s factored into various media types. The modality is determined in the learning strategy step outlined by John previously, but can vary from flat files like PDF, to more visual formats like PPT, to multimedia videos, or packaged interactive eLearning content. That requires similar workflow and tools as the first step, but now interactive developers are added to the mix. Various authoring tools, from the Adobe Suite to Articulate Storyline and possibly video production are added to the mix.
The third step has a variety of different parts, and is marked by SME approval at differing levels within the organization. You get final content approval. You add the alignment of content to curricula, and then qualification sets, and entire learning plans or training matrices. Now we are adding managers, department heads and others to a round of workflows. Spreadsheets and emails become critical. And this is a final step to deciding the INPUTS for an LMS
The final step is configuring an LMS to deliver assignments, and then using it to track them. This is a stand alone system that consumes the inputs described and delivers tracking data back. Often, an LMS admin is another stakeholder that may or may not have been involved in the preceeding steps.
Viewed this way… we can think of the training development process as a linear, well-defined progression, with discreet traceable steps. But…
Kent
That’s not reality. The process can be easily swim diagramed. But when you include the means of enabling those varied processes, it’s anything but linear. The starting point and end points are the same, but the reality of GETTING to that assignment status – did John complete his SOP R/U and GMP eLearning assignments, and were they on-time … are all critical to delivering efficient business process and providing evidence of compliance.
And this is where the loop is broken.
Let me provide an example.
One large pharma company that I worked with outlined their stark reality. On the GXP side, DMS, 4-5 fileshares just for GCP, email and spreadsheet approvals for about 300 participants in the content development process, the resulting plans stored back in fileshares… and pointed links are given to admins for 2 interral LMSs and multiple portals for external training,. Keeping track of two versions of a single eLearning course – required for two different delivery technologies – one piece of content, requires ALL of these methods of tracking.
Thes are all learning technologies. All.
John / Kent discuss to setup
So John, we know large enterprise customers expand to approaching 100 learning technologies, but they are typically counting LMS-like delivery products, when consider everything described, how much bigger to do you estimate that would be?
Consider smaller companies as well, we kept these choices low… but…
To John
John
To Kent
So, we want to encourage you to look at the learning strategy holistically, and do your best to close the loop. Find a way to connect each part of this disparate processes…
Kent & John discussion back and forth
Looks something like this…
This can be done via integration, if possible.
Challenge with multimedia development (it can be OUTSIDE the loop, as along as it’s anchored to the loop)
Kent
It’s easier if we break down some of the key considerations…
Kent
Similar concerns about GXP and non-GXP with doc management solutions as there are with LMS solutions
No, you don’t want to blindly co-mingle, BUT… every part of the org that creates and manages source documents has training derivatives. You should both have the flexibility to add those to your hierarchy, make them less governed, and create a downstream management of related content so a source doc, can be associated to a storyboard, to media assets, to interactive packages.
Kent
And then you have version control and a traceability that does NOT exist if you are relaying on email and fileshare. I’ve seen this.
In the approval process, it is one extreme or the other. Controlled documents are managed in a DMS, but a correlating ILT session is developed locally. That doesn’t allow for visibility.
Or, source content – often in commercial training – is developed locally, all the way through interactive eLearning packages. Then those are routed through a DMS for MLR review, without even being renderable, so a storyboard is relied upon. Even in a closed loop scenario, it’s already been broken.,
John
John
Kent
Unification over integration.
This isn’t just technology. It’s also a process problem.
LMS selection often involves content. And sometimes that leads to secondary or tertiary integrations. It’s not going to be perfect. SO it’s important to ask yourself where the compliance loop is best closed and how that
Another specific example… find an LMS that naturally delivers assignments through other business processes – like CAPA