Interview with a CEO: Solution Evolution Part 3 of 3

Interview with a CEO: Solution Evolution Part 3 of 3


We’re through the pre-Tx3 days, we’ve made it through the early Tx3 days and we’ve arrived all the way at the current day. That’s a lot of time to cover in a condensed blog series, but hopefully the abbreviated flip through the history pages has provided you with some context on some of the gaps and issues we’ve seen on the compliance and technology side of regulated software quality over the years, and how Tx3 CEO, Jason Tepfenhardt and the Tx3 team have worked to shore those leaks up and push the life sciences industry forward.

So, what does the current landscape look like? What can be done to help teams get to that next step in their regulatory evolution? How does one promote adoption to a sometimes-reluctant audience in a heavily regulated industry?

These are some of the things Jason discussed as we move our timeline into the current day.

Today and Tomorrow

A lot of what we are seeing today is what we might describe as the pendulum swinging back a bit in response to an era where compliance and validation practices kind of got out of hand and ended up becoming overly burdensome. As a result of those practices, what should have been the main objective of software quality was being overshadowed by documentation and documentation practices.

Some of the trends born of that era (which have also bled into today) came in the form of both compliance solutions that offered little more than keeping teams beholden to the time when the document ruled all, as well as complex over-engineering and customization of software quality and compliance solutions.

Jason and the Tx3 team’s response to those issues was to develop a nimble compliance approach that could be applied across numerous solutions and utilized by teams operating in various stages of their digital transformation journey. To be able to show teams that it was possible to achieve and verify compliance without taking a “document first” or “document everything” mindset, and without overcomplicating the processes. That it was possible to do so while reducing risk and achieving what should be viewed as the primary goal – from both an organizational and spirit of the regulatory law standpoint – which is software and product quality, while at the same time completely appeasing FDA requirements.

In short, and I’ve said it before, but it bears repeating, it is about showing that compliance deliverables can and should be achieved as a byproduct of good software quality practices, rather than being secondary to documentation practices.

Of course, all of this has been put into practice and enabled through the development of VERA, which discussed in the last post, but let's stay focused on the current mindset and regulatory landscape side of things.

As we moved into 2019 and now have arrived in 2020, there has been a lot of industry-backed momentum behind this "getting back to quality" approach. Not just from teams in prominent organizations, but from the FDA itself. However, there is still some work to be done when it comes to industry-wide buy-in and adoption.

“There are recent pushes and initiatives, such as non-product CSV, and a new guidance that is supposed to be published soon on CSA (Computer Software Assurance), but a lot of this is saying what industry SME’s say needs to be done, but not necessarily how to move forward and do it.”

The technology and processes are certainly there to support this, and some organizations have effectively shifted in this direction already, but it doesn’t necessarily appear easy from the outside and it can even be hard to wholeheartedly embrace. While it’s true that we are seeing a lot of discussion around this shift from traditional validation (including some participated in by representatives of the FDA), the reality is that nothing has officially been published yet and it can be challenging to make that first step without a formal blessing, even when a proven roadmap is there.

Still, the general reluctance or apprehension is understandable. Wrapping one’s arms around a new way of doing things in a highly regulated environment - in an atmosphere where teams have been conditioned for years to think things have to be done a certain way - can be a tough shift to embrace. Facilitating this transition is more than just a technology and process conversation. It’s a cultural mindset change that needs to be nourished.

“It’s more about culture shift and education, coupled with a new generation of technologists and leaders helping pave the way and guide the senior traditionalists.”

While this is not necessarily unique to this topic and it holds true across many industries, given the nature of a highly regulated industry, this becomes especially poignant. It’s about education and enablement as much as it is finding a trusted advisor or SME that you can put the faith of your team and organization in.

This remains an extremely important aspect of Jason’s continued vision for Tx3. That clients and industry peers can lean on Tx3 as strategic advisors and thought leaders as it pertains to the execution of technology adoption and process improvement in a regulated environment.

“We want to help our customers stay on the cutting edge while navigating regulatory compliance and to be their escort as they undergo things like, say, waterfall to agile transformation. Even taking those two processes out of the mix, it’s really just about executing continuous process improvement and modernization.
Understanding the needs of their business and how to adopt the technology and processes to achieve those needs and goals in a regulated environment.”

And that’s really the crux of it, isn’t it? Ensuring success today and making sure that we can still provide that tomorrow, regardless of how the technology and process landscape changes – and as we discussed a bit earlier in this post, some of those “tomorrow” changes are really already upon us.

I think that should about wrap it up for this series, but speaking of some of those “tomorrow” changes, be sure to check back over the coming weeks (or just subscribe so you get automatically notified) as we will be publishing our thoughts on the upcoming FDA draft guidance around non-product CSV, or “CSA”. We touched on it a little here, but it certainly warrants a deeper dive in a dedicated series as it will certainly have a noticeable impact on the industry in the months and years to come.

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