SDLC Modernization in Life Sciences: People, Process, Technology, and Culture
In the Life Sciences industry, implementing change is not always as simple as making a decision and saying the word “go”. Even when the need for change and improvement is recognized, there are a number of factors that can make getting to the point of implementation and utilization a tough road to navigate and travel. Still, SDLC modernization initiatives across the industry have become more and more prevalent, so understanding some of the navigation points up front can be the key to the successful execution of a modernization strategy.
When we refer to SDLC modernization, we are talking about several areas in particular that need to be addressed. Understanding the current state of these areas within your organization relative to the end goals of your modernization strategy will be crucial to supporting enterprise-wide improvements to the end-to-end software lifecycle. They are:
These four areas are important for any organization to take into account, but especially so in Life Sciences. Why? In the Life Sciences industry, improvements in these areas are interwoven with regulatory constraints, historical interpretations, and emerging guidance or regulations that all need to be taken into account. Beyond just being taken into account, they need to be adjusted, balanced, and implemented in a cohesive strategy alongside your SDLC modernization initiative.
While regulatory compliance can pose some challenges, many Life Sciences teams have successfully undergone modernization initiatives in both their SDLC and compliance practices. In doing so, they have been able to utilize effective automation, and to harness tools and methodologies that many other industries have already been able to use to great degrees of success.
So what do we need to understand about these four areas so we can make traveling our modernization road - both from an SDLC and regulatory compliance perspective - as smooth as possible? How about we do a quick little overview, shall we?
Let’s begin by taking a look at process….
When it comes to process, it’s really about taking a look and evaluating processes and procedures that have likely been in place for many years. What is currently in place at many organizations from a process standpoint probably comes from a time when practices, tools, and methodologies for development and software quality were approached differently than they are today - as were the compliance practices that supported them.
Where this becomes problematic is that a shift to something that more closely resembles agile is really what the Business is increasingly demanding. As a result, adjustments and overhauls of process that most likely supported something closer to waterfall will be needed in order to support that.
The reality is that Business processes and Business technology have outpaced these legacy processes, but simply plugging in a new piece of technology is not enough on its own. Embracing an implementing a commensurate approach to SDLC and compliance processes to support more modern methodologies and tools is required.
Speaking of tools…..
In terms of technology in the context of SDLC Modernization in Life Sciences, we are talking about the continued adoption of agile and DevOps tools. Teams should be striving to further expand automation and SDLC integrations into CSV processes without carrying forward disruptive legacy processes.
While pure agile may not be a required or even desired state for many teams, leveraging agile oriented tools - even in a hybrid solution architecture - will yield great results in both speed and quality of software quality projects. Of course, only when coupled effectively with the appropriate process shift.
It should also be noted here that I'm not necessarily talking about pulling out a credit card and buying all new technology to fill your stack with the latest and greatest tools. Part of the technology component in a modernization strategy is taking a look at what is currently owned and being used, and figuring out areas where an optimized strategy with those tools could better benefit the entire enterprise.
Jira, for example, is a very common solution that we see used by one or several groups within an organization, but often times its use is siloed to those individual groups and their specific use case. This is the type of scenario where organizations can further leverage existing technology investments by expanding them for a more unified usage across the enterprise.
People are a factor that can be just as complex as any bit of technology out there. There are existing skill sets possessed by the people that make up any given team, as well as skill set gaps. Understanding those skill sets will allow you to understand areas where teams excel that can be further built upon, or where a shift in skill set is required to support the refresh in new processes and technologies that will be introduced as part of a modernization strategy.
Training and enablement are key to make sure that the people interfacing with technology and executing defined policies and procedures are doing so effectively. Adding shiny new tools is all well and good, but without providing an appropriate training plan structured around that tool's use within an organization's defined processes, the results may not be as stellar as that ROI report you had created would lead you to believe. Proper enablement of personnel in both technology and process should allow for effective use of tools as well as drastically mitigate the risk of human error in the compliance chain.
Also, it is crucial to get personnel onboard early in the process with frequent communication to not only avoid confusion, but also to navigate potential internal pushback.
As important, if not more, as anything we discussed above, is addressing the culture shift within an organization that will be required to make these types of initiatives successful. One of the more common obstacles that we come across is a very ingrained way of doing things based on the way things have been done in the past - which is stems back to some of the points we discussed around process.
Addressing the culture of an organization often requires confronting a deeply embedded mindset and way of doing things, so early buy-in, frequent communication, and incorporating constructive feedback from key-stakeholders within the organization is a key component to undertaking a successful transformation. This means an early, often, and continued top-down and bottom-up communication strategy should be in place.
Without being able to address and get buy-in on a culture, or mindset shift within an organization to support an SDLC modernization strategy, the chances of success are drastically reduced.
Summary and Additional Resources
A cohesive strategy across each of these areas begins with taking a realistic assessment of the current state in each. Once improvement areas are identified, a move forward plan with appropriate process and technology adjustments should be discussed with key personnel across the various teams with proper training and enablement defined (this should also be ongoing, not just up-front). It is important to remember that each of these four factors play into the other and are required to be adjusted and utilized in unison in order to be successful.
Bad processes and processes built around older methodologies that don't get re-defined can drastically limit the efficacy of agile oriented tools, negating the investment an organization makes in them. Ill trained/ill informed team members are likely to deviate from policy, especially so if appropriate governance is not evaluated and applied. This will also likely lead to ineffective utilization of technology across the SDLC. Disparate mindsets in culture across the organization can make any change a nightmare to propose, let alone enact. And on, and on, etc, etc.
This is certainly a topic that could be spanned in much more depth, but alas, this was meant to just be a high level overview. The good news is that we are currently building and providing additional resources to take a more comprehensive look at modernization strategies in Life Sciences.
To start, if you would like a more in depth resource around this topic, pre-order our free E-Book, “Standardizing Compliance to Achieve SDLC Modernization”. Once it is made public, we will deliver a copy via email.
In the meantime, you can also feel free to view this on-demand webinar where we discuss the same theme.
Jason Secola manages content marketing and channel activities at Tx3 Services and has been with the company since 2016. Jason began working with the larger portion of the existing Tx3 team dating back to 2007 when he got his first start in the world of application testing and later began a focus on testing in a regulated environment. He currently resides near Sacramento, CA.
Jason Secola manages content marketing and channel activities at Tx3 Services and has been with the company since 2016. Jason began working with the larger portion of the existing Tx3 team dating back to 2007 when he got his first start in the world of application testing and later began a focus on testing in a regulated environment. He currently resides near Sacramento, CA.View all posts by Jason Secola