Adoption of Hosting and SaaS in Life Sciences
Why Cloud and SaaS?
For many organizations over the course of (semi) recent years, leveraging cloud infrastructure and/or SaaS offerings has become extremely commonplace. And why not? There is a slew of benefits to be had when offloading infrastructure and application ownership and administration overhead that can allow teams to focus on development, quality, and release cycles that contribute to overall business objectives. The model has proven extremely effective and beneficial to many teams across numerous industries.
For IT Operations and Infrastructure teams, being able to offload even a portion of managing complex and robust internal infrastructure demands can drastically reduce year over year expenses. Not just specific to the cost of the infrastructure itself, but also in variable areas of infrastructure support that can sometimes be difficult to account for.
- Handling and remediation of internal support
- Management of service requests
- General administration
- Management and maintenance
- Spinning up and provisioning new environments
- Latency and outage protection
- Backup and disaster recovery protection
These are just to name a few, but in a hosting or IaaS model, all of these tasks can be offloaded and managed by the vendor, freeing up resource availability and reducing the cost and effort associated with supporting these activities internally.
For teams that focus on software and applications, leveraging a hosted application or SaaS model can allow them in instead to focus on development, quality, and delivery, rather than dealing with the yard work of application ownership. Meaning they can focus on job functions and initiatives to support the business, instead of having to spend time on various administrative tasks that often come with application ownership.
- Setting up new projects
- Providing or updating user credentials
- Coordinating service requests with internal IT resources
- Application patch rollouts
- Version upgrades
From the IT infrastructure and operations side to the software side, the benefits really begin to add up for teams that have been able to effectively leverage these models. Resource constraints are minimized, business objectives can be more effectively focused on, and costs associated with infrastructure/application ownership and administration can be greatly reduced. In addition, costs that would normally be incurred via CapEx budgets can now be absorbed via OpEx budgets, leaving CapEx available for other business initiatives.
However, while many industries have been able to successfully embrace these models, there have been some adoption challenges for Life Sciences teams given the nature of operating under strict industry regulations.
Obstacles for Life Sciences teams
I’ve made this analogy before, but very often major hosting or SaaS platforms are like cafeteria food. They are designed and set up with a broad audience in mind and they need to function efficiently to service as wide of a consumer base as possible. The more standardized and simple everything is, the less the cost of operations and support. The more individual and unique tastes are accounted for, the higher the cost and complexity of support. Unfortunately, this leaves those looking for bolder and more unique flavors out of luck. I’m afraid you’ll have to settle for the standard fare of turkey, green beans, and red jello.
How does that analogy apply here? In this case, infrastructure and application hosting providers are often not able to adequately service a niche Life Sciences market governed by very specific regulatory compliance requirements - or at least may be unwilling to do so without negotiating custom and difficult to manage service agreements at additional cost.
Some of the issues Life Sciences teams commonly run into on the infrastructure side:
- Lack of understanding around industry infrastructure requirements
- Infrastructure that is not designed or maintained to qualification standards
- Inadequately defined policies and SOP’s per industry specifications
- Lack of supporting documentation around policies and architecture
When audit time rolls around, all of these blind spots will leave the customer in a position of not only not being able to request required documentation from the hosting provider, but also unable able to generate the necessary documentation on their own to verify infrastructure qualifications specifications are being met. If that infrastructure is then being used to host validated applications and GxP related systems, these gaps in compliance could have very detrimental results.
If we move over to the software and SaaS side of things, many of the same issues exist, but there is also an additional set of issues that need to be taken into account. A big one comes in the form of lack of control over the application itself. While that does come with benefits for many non-regulated organizations - in the form of reduced internal support, maintenance, and administration requirements - for regulated teams, the lack of application control has its downsides.
These downsides are largely dictated by the SaaS providers need to support a large number of customers, and therefore need to minimize the various version and patch levels that need to be supported at any given time. Again, it's cafeteria food.
For life sciences teams, this means continuous cycles of:
- Patch releases and version upgrades
- Subsequent UAT and validation testing
- Increased demand for generating appropriate verification deliverables or documentation
Couple these with the fact that OEM’s are either unable or unwilling to validate their own applications and supply their customers with validation documentation or audit responses, and the validation effort stacks up when application control is not allotted to the customer. If we assume a schedule of even 2-3 patch releases and one full version upgrade a year, Life Sciences quality and validation teams would essentially be on a never-ending hamster wheel of UAT and validation testing for just that single application.
In both scenarios, the lack of industry-specific considerations leaves much additional strain and burden on the regulated team, as well as potential gaps in compliance that the customer will simply have no control over, yet will be accountable for.
What can be done?
The good news is that it’s not all doom and gloom for Life Sciences teams looking to leverage a hosting platform or a SaaS offering. In fact, many teams have begun to accomplish this to great success, but some scrutiny and proper alignment are required given the knowledge that many major hosting and SaaS providers do not properly accommodate the requirements that Life Sciences teams have to adhere to.
So what should you be looking for in a provider of either IaaS or SaaS models? If you’re looking for the right things, you should really be identifying more than just a service provider. You should be identifying a partner.
- Align with a service and technology provider that is focused on your industry, or that at least has a practice dedicated to it
- Is willing to supply appropriate documentation
- Allows for application control over patch and version release schedules
- Has a team of industry experts maintaining and providing infrastructure/application administration and support
- Does not require cumbersome custom service agreements to meet your requirements - especially at additional cost
With the right partner who has industry-specific focus, customers can be assured that infrastructure and software offerings are executed with compliance in mind, and with required documentation to satisfy the FDA. This should sound like music to the ears of Life Sciences teams as they won’t need to set up highly customized service arrangements with providers requiring additional cost and management to appease their qualification, validation, and documentation needs.
On top of the reduced burden of managing the full lifecycle of qualification and validation (some of these tasks will always have to remain with the owning team), the additional benefits of cloud platforms and hosted solutions now become available. Reduction in internal service requests, application and infrastructure administration, resource allocation, as well as the overhead of purchasing, managing, and maintaining a full internal infrastructure.
If cloud and hosted applications in a regulated environment is a topic you are interested in learning more about, please register for a webinar we are doing on July 30th, “Purpose Built SaaS: Agile Testing and Qualified Cloud for Life Sciences”.
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