Use Case: Applying Testing And Validation Maturity Models

Use Case: Applying Testing And Validation Maturity Models

As we’ve discussed over the last couple of posts, we have extracted a few portions of a recent presentation Tx3’s own Dori Gonzalez-Acevedo did at a KENX virtual conference. Yes, some might say it’s cheating to say “I’m” doing a blog when I’m just turning around and hijacking the great work one of my colleagues did, but hey, one could also call it an homage to great content that I just felt needed to get showcased around a bit more.

Yep, I’m going to go with the homage explanation.

In any case, the last post was in regards to some of the common terminology and methodologies we discuss when looking at Testing and Validation Maturity models in a regulated environment. Before that, we focused on what the coupling of a Testing Maturity Model and Validation Maturity Model should look like (here and here)

This week, I thought it would be a good idea to put it all together and discuss an actual use case where we developed a multi-year strategy with one of our clients and began to move through the phases of the Validation Maturity Model we discussed. It’s an ongoing effort (as many things are in our world), but it’s reflective of what is possible and what needs to be done to achieve it for other organizations out there that are looking to modernize their testing and validation practices.

Let’s quickly walk through the journey of one example.

As I mentioned, many of our clients work with us over the course of several years to map out and execute strategic initiatives. In this case, we have a multi-billion dollar company that manufactures various products across multiple industries. This includes medical devices, integrated medical devices, and drug products. In addition, there are a number of other products that span other heavily regulated industries such as automotive and aerospace technologies.

Back in 2014, senior leadership at our client recognized the need to deploy a paperless Testing Center of Excellence in preparation for an enterprise manual factory execution deployment. Their problem at that time was presented as a 100% paper-based system and process. Further complicating matters, there were no dedicated resources to manage this and there was no standardized process throughout the organization. 

At the beginning, Computerized Systems Validation and other Validations were all being done manually and it had become very difficult to reproduce and to manage. As a result, the desire was to deploy a paperless TCOE. Senior leadership recognized the need, had the desire to move to action, and identified the right strategic partner (that’s Tx3, if I can toot our own horn for a second) to define and execute a plan of action.

Our approach was a multi-year transformation that included all key elements across the organization, including people (and culture), process, and technology. The first step was to ensure that the organization was where we expected. To do this, we conducted interviews, surveys, and gap assessments with key stakeholders throughout the organization. This allowed us to clearly establish where the problems were, and to create baselines of where they were at from a people, process, and technology standpoint.

Through these efforts, we were able to identify and discuss what industry best practices were, how they could be applied, and ways to illustrate how to standardize business processes. Most importantly, we helped the client to be able to recognize the importance of a strategic plan over the course of multiple years. This would increase their likelihood of success. Spreading awareness by education also helps to form the basis of a foundation that requires true organizational transformation.

During the first phase, we were able to shift to 20% of validation and SDLC deliverables in an electronic application lifecycle management system, setting the precedent for one critical business unit to be established in a controlled process capacity. 

Over the course of the next period of time, we were able to pick up velocity with an established process rolled out to other business units, making adoption much easier. There was a continuous improvement loop and feedback mechanisms were in place to be able to integrate new technology solutions and advanced their testing methodology. Being able to identify the right business units to engage and socialize this with, the goal of moving towards a 50/50 paper to paperless solution was achieved. 

The last two years have been focused on the final step in the Validation Maturity Model, where a full paperless TCOE is in place and the are operating in a Data-Driven approach. This is coupled with a strategic rollout of test automation and agile-oriented SDLC solutions and processes. 

However, this is still in progress. This is still an ongoing effort. We have implemented a test automation framework for a limited need at the moment, as have we begun to move our paperless, Data-Driven solution to other business units. The expansion continues, but it all started with key stakeholders at key business units buying in and helping to drive the vision forward.

Now, with success under their belts and verifiable data to take to other areas of the business, enterprise adoption and rollout becomes much simpler, and more quickly embraced..

Of course, this is just a high-level overview of some of the aspects of this project, but I wanted to spend a little time describing how the items we’ve discussed over the course of the last several posts can come together at an organization, and a bit of what is involved to get there.

It’s a complex initiative to take on, but with the proper planning and execution, great results can be achieved that will far outlast the effort of the initial undertaking.

I know I've mentioned this before, but I would again encourage you all to view Dori Gonzalez-Acevedo’s (LinkedIn) great presentation on “The Evolution of Paperless Validation” to hear all these topics (and this case study) brought together. I also provided a link to her LinkedIn profile above, so please feel free to reach out and connect.


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