Interview with a CEO: Solution Evolution, Part 1 of 3

Interview with a CEO: Solution Evolution, Part 1 of 3


As luck would have it, my fortunate readers, I was able to catch a one-on-one with Tx3’s CEO, Jason Tepfenhardt.  Captain of industry. Tycoon of regulated software and services. Tyrant to those who would presume to step in his path. A veritable giant in the age of technological enormity!

Okay, so maybe some of that is a bit hyperbolic, but we live in the era of over the top sensationalism in media and publications, so I had to throw in a bit of flair for the sake of flair.

Nonsense aside, Jason and his expertise in the life sciences industry, coupled with that of a few other capo’s over here, have played a large part in the vision of Tx3 and, subsequently, how numerous FDA regulated organizations have effectively managed and enhanced their software quality and compliance activities over the last 15 years or so. As a result, Tx3 (in current and previous iterations) has played a large part in influencing and contributing to how the industry has evolved over the years.

I was able to speak with Jason on a number of topics that I’ll be peppering into posts and blog series over the coming few months, but one area in particular that I thought would make sense to kick things off is with a bit of familiarization with Tx3. Where we came from, what our executed visions have been, what they are today, and where we see things going.  After all, you are reading our blog, so getting a bit of context on our organization is probably going to be a useful thing.

Now the question is, how exactly will I convey all that? It’s a lot to cover and not everyone loves a basic history lesson, nor do I want it to come across as just a blogger espousing the virtues of the company that pays his checks.  Instead, I want this to provide a little context around Tx3’s expertise and place in the life sciences industry in 2020 and beyond.

Ah, I think I’ve found a way!

What makes up Tx3 is a bit more complex than what I’ll cover in this specific series, but much of the amalgamation of those complexities manifest themselves in the form of our flagship solution, VERA Validation Electronic Records Approval). 

Don’t worry, my dear readers, this will not be a product commercial. Rather, through using the solution and its evolution as more of a guiding rod, we will walk through some of the histories of Tx3. Starting at the state of the life sciences industry and CSV from the days before Tx3, to the start of Tx3, to the current day of Tx3 and where the trends of today are likely to lead us in the coming years.

Okay, before I eat up my word count for this post with more preamble, let’s just start diving into it.

The pre-Tx3 Days:
Genilogix and eSignature/eApprove

The derivation of Tx3 and what would become VERA started at a company called Genilogix. Genilogix was a software reseller and service provider in the test automation, test management, and performance testing space. The primary solution focus and expertise was around (at the time) Mercury Interactive’s set of tools, which would later become HP, which would later become HPE, which is now Micro Focus.

Anyway, I don’t want to get too much into Genilogix other than to point out that part of our/their focus was around what was then called TestDirector, which became what we know of now as Quality Center/ALM.  More importantly, it was at Genilogix where the Life Sciences Division that later became Tx3 was born.  At that time, the state of testing and validation was very different than what we see today (or maybe still the same, for some folks out there).

Back then, the focus was just starting to get into automating and modernizing the testing aspects of the V-model style of validation. Today, that still occurs, but we see a shift happening toward focusing on end-to-end software quality and by doing that correctly, documentation is a natural byproduct instead of a product all its own.

I’m jumping ahead a bit and I’ll cover more of that as we move further into this series, but let’s go back to the world of testing and validation at that time.  As Jason says…  

“It was waterfall based. Organizations were just beginning to figure out how to automate part of the CSV landscape and a logical place to start was automated test management with the hopes of achieving test automation in the future as organizations matured with their processes and tools”.

In response to this and to fill a need amongst life sciences teams looking to embark down the road of automated test management and functional test automation, came a solution called eSignature, and later, eApprove (I’m now realizing over the last few paragraphs that naming conventions sure do change often). 

Jason Tepfenhardt and his partners (like future star of this blog, Eric Toburen) were the masterminds behind the development of this solution, which was designed for life sciences teams using ALM (I know it was TestDirector at the time and I know it’s also called Quality Center/QC depending on version, but I’m just going to call it the current flagship name, ALM, from here on out.  On that note, eSignature will just be called eApprove moving forward).

“eApprove was purpose built as a plug-in to ALM to provide workflow controls, process governance and electronic signatures to enable the use of ALM as a system of record for software testing. SAP implementations were the big catalyst in the early to mid-2000’s for the implementation of QC/ALM with eApprove.”

From there, eApprove took hold at almost all of the top global pharma and biotech companies that were using ALM, but lessons were learned from those early iterations of the solution. There was a lot of success and the solution proved to be more than up to the task. It also proved to be very forward thinking, but it wasn’t perfect (we’ll cover that in a bit more detail later).  Over the years, the changing process and solution landscape was starting to expose that a bit.

We don’t need to get into some of the politics that transpired which ultimately lead to the creation of Tx3, but to summarize, Genilogix was acquired and not long after that acquisition the legacy Life Sciences Division of Genilogix made an arrangement with the acquiring organization to spin off and start Tx3 while maintaining a strong partnership and a tie to eApprove support and development.

With Tx3 now formed and the lessons learned from the eApprove days, an evolution was ready to take place.  Born was the next iteration of quality and compliance solutions, Tx3 VERA.

I’ve already gone quite long in this first post, so I think this makes as good a spot as any to take a break. In next week’s post, we’ll start diving into the early days of Tx3, what some of the lessons learned from the eApprove days were, and how they shaped the organizational vision of Tx3 and development of VERA.

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