On Friday the 16th of December Odyssey VC hosted the fourth and final part of our 2022 webinar series “Possibilities and Practicalities of Cloud Adoption in Life Sciences”.
Across four sessions throughout 2022, Odyssey’s team of experts came together to explore how we, as a community, can support the adoption of cloud technology in our industry. From considering the initial steps to building a successful regulated cloud adoption strategy and selecting fit-for-purpose cloud solutions, many fresh insights have been shared throughout the first three sessions and Part 4 tied it all together.
Part 4, titled “Agile development methodology that satisfies regulatory requirements”, was an exploration into how an agile approach to software development presents a need to revise the traditional dependency on approved documentation as an output to demonstrate validation, moving towards availability of agile artifacts that provide traceability of the verification activities. We also explored how the agile DevOps software model can be adapted to incorporate GxP regulatory requirements.
With presentations from Head of Strategy & Product Pauline O’ Riordan and Head of Technology Mark Healy, as well as a panel discussion including Odyssey VC Co-founder and Head of Business Solutions Fionnán Friel, Part 4 was brimming with key insights. Read on to discover four key takeaways from Part 4 of “Possibilities and Practicalities of Cloud Adoption in Life Sciences”.
The adoption of Vertical SaaS in Life Sciences is accelerating
Head of Strategy & Product Pauline O’ Riordan delivered the first presentation of the webinar on the adoption of Vertical SaaS in Life Sciences. Currently the strongest area of SaaS application in Life Sciences is Horizontal SaaS, which Pauline described as “solutions from providers that service more general business functions, for example Sales, Finance or HR”.
The rising trend of Vertical SaaS, however, is challenging the ubiquity of Horizontal SaaS. Vertical SaaS, simply put, consists of applications “designed to solve specific industry pain points”, as put by Pauline. Although horizontal SaaS has been the dominant model for well over a decade, the adoption of Vertical SaaS is accelerating.
Why is this? According to Pauline, it’s because Vertical SaaS providers “are not interested in being all things to all customers. They’re really concentrating on the best solution for their customers in their industry.” Vertical SaaS providers cater to a niche market, offering more focused solutions and thus are ostensibly able to adapt to the needs of their customers more readily.
Delivering software solutions like Vertical SaaS to the Life Sciences industry doesn’t come without its challenges
In her presentation, Pauline was quick to point out that, although the trend of Vertical SaaS has been picking up steam, it is not exempt from the unique challenge of catering to customers in the Life Sciences industry. As we’ve touched on throughout the series, the FDA states that “The regulatory requirements do not change because the technology changes, infrastructure must be qualified and software still must be validated.”
This means that, as adaptable as the Vertical SaaS model aims to be in terms of narrowly providing to the needs of a specific vertical, they can still face the same roadblocks when delivering to such a conservative industry with a reputation of being somewhat resistant to change or otherwise slow to adapt.
“It is likely that your application is going to be handling regulated data. So there will be an expectation that the application you provide is validated and can be audited,” said Pauline. “Your customer – the Life Science customer – has to ensure this in order to satisfy the international regulatory bodies and ultimately look after product quality and, in the end, patient safety.”
Combining contemporary practices like Agile and DevOps can help streamline and integrate compliance into software development
Odyssey VC Head of Technology Mark Healy’s presentation built on the foundation laid by Pauline to dive into the issue of how to leverage DevOps in order to streamline compliance. In software development, contemporary methodologies are leveraged to increase agility, decrease time to market, reduce maintenance efforts and maximise availability and reliability.
However, according to Mark, “with all those improvements, validation is always seen almost as an afterthought”, an add-on or post-deployment exercise. Achieving the best of both worlds is the ultimate goal; the question, according to Mark, is “how can we take this Agile, adaptive and flexible development process, but also produce software that’s safe, validated and fit-for-purpose.”
Agile development methodology and compliance and validation have similar focus areas; they both have defined processes and they’re both “looking to make sure that software is fit-for-purpose, that it works properly, that it’s properly tested.” Agile focuses on adaptability, repeatability and scalability, while compliance and validation focuses on making sure that the functionality is well defined, that the software is dependable, and that changes and releases are controlled.
“It’s almost like we’re working tangentially in the sense that we’re doing very similar things but for very different purposes,” said Mark, which is where Compliant DevOps comes in, with the goal of “seeing if there’s a way to combine these two mindsets and work to a common focus.”
Compliant DevOps is the best way to combine the benefits of Agile and DevOps for a more compliant software development process overall
Mark touched on Compliant DevOps in his presentation from Part 2 of the series, describing it as an extension of DevOps, specifically designed for Life Sciences. In that presentation Mark acknowledged that “a common problem in IT over the years has been the misalignment of teams,” pointing to Compliant DevOps as a method of eliminating these issues.
Expanding on this for Part 4, Mark underlined one of the key benefits of Compliant DevOps as the aligning of requirements across Product, Development and Test teams, “developing a common language across those three functions” where everyone involved understands the scope and requirements.
Mark emphasised that “we’re not necessarily changing DevOps but structuring it in a way that the evidence we need for compliance is gathered as part of a standard development process. We’re not developing and then taking a step back and starting compliance afterwards; they’re both fully aligned and integrated with each other.”
This highlights a common thread through all four parts of the series; compliance is easier to achieve and maintain when it’s built into the process from the start. The “fail fast” approach of DevOps can seem at odds with the tight controls and extensive testing involved in validation, but through Compliant DevOps the process is controlled, changes are implemented quickly and efficiently, and evidence moves from point-in-time documentation (a “huge, singular effort”) to an “ongoing, almost real-time data collection process”.
“To me probably the most important benefit of what we’re doing here is that we have data-driven processes that produce the evidence that we need, when we need it,” said Mark.
At Odyssey VC we offer solutions for Compliant DevOps, using a framework designed to adapt the DevOps model to fully incorporate GxP regulatory requirements. Let Odyssey VC support you in the continuous and compliant delivery of high-quality software releases; click here to learn more about our Compliant DevOps solution.
With that we bring our 2022 webinar series to a close. We hope that this series has shed some light on the considerations and practical steps around cloud adoption, and that you take with you some nuggets of advice from our team of experts when pursuing your cloud adoption goals in 2023, at a time when it’s never been more pertinent to embrace new digital tools to deliver your solutions.
In Pauline’s words; “Life Sciences companies are seeing more and more the benefits of using cloud as a foundation for digital transformation. It’s not just about running a more streamlined business, lowering costs or scaling on demand, but more about embracing new ways of working, the ability to unlock data, collaborate across ecosystems, and ultimately create more meaningful products and medicines that will improve patient outcomes.”
We are delighted with the reception to these webinars throughout the year, and excited to keep building on this established base of vital insights to help our customers in achieving their digital transformation goals – make sure to keep an eye out for news about future webinars!
Thank you for your continuing support and, as always, your feedback is welcome and very much appreciated. If you’d like to watch all four parts of the series, you can still register here for a limited time to receive the video links. Don’t miss the chance to add these informative webinars to your library.