The Fastest Way to Digital Validation? Cloud Automation

Learn why cloud automation is an important driver of Pharma 4.0™ and how it is leveraged by Kneat’s SaaS engineering team to optimize the performance of our digital validation software Kneat Gx, and make validation easier, faster, and smarter for life sciences.

By Sean Daffy, Manager SaaS Engineering, Kneat 

The Fastest Way to Digital Validation? Cloud Automation

In the life sciences industry today, an increased uptake of the Pharma 4.0™ (1) initiative has resulted in forward-thinking organizations shifting from manual paper-based validation activities and installation activities to using more advanced cloud-based software-as-a-service (SaaS) industry tools and technologies. Kneat leverages specialized cloud automation processes—like infrastructure-as-code, immutable infrastructure and containerization—to enhance the delivery of our digital validation solution, Kneat Gx and provide an easier, faster, and more responsive validation service for all our customers.

In this article you will learn:

     ✓  What is cloud automation

     ✓  Kneat’s use of specialized cloud automation tools

     ✓  Why companies are transitioning to the cloud

     ✓  The benefits of cloud automation for our customers

What is cloud automation?

Cloud automation is Kneat’s initiative to enable the delivery of self-propelling, on-demand services that scale dynamically to meet demand. Cloud automation enables software engineering teams and developers to create and modify resources on the cloud in an efficient and controlled manner. Cloud automation is not integral to the cloud. It is complex and demands expertise and the use of specialized tools, capabilities, and effort.

Kneat’s use of specialized cloud automation tools

At Kneat we build our best-in-class SaaS platform using the building blocks provided by AWS’s cloud infrastructure AWS (2). Leveraging AWS’s extensive suite of services and underlying infrastructure we are able to deliver a highly responsive and performant SaaS solution to customers wherever they are located around the globe. We utilize an extensive suite of cloud automation tools to deliver our SaaS solution, but the tools we use most are HashiCorp Terraform(3), HashiCorp Packer (4), and Kubernetes (5).

Terraform

Terraform is an infrastructure as code software tool that enables us to define the infrastructure required to operate as code, which we can then version control and subject to an SDLC (software development life cycle) process to ensure consistency. This means that we can quickly, safely and predictably create, change, and improve infrastructure.

Packer

HashiCorp Packer is a tool for creating golden server images (templates) which can be built once and then deployed multiple times. Packer allows us to apply immutable infrastructure principles to our infrastructure deployments where we build an image once in automated fashion, subject the image to extensive testing, and then use that image to ensure that we deploy exact replicas of the validated server image to our customers. Should a change be required we build a new image and re-run the testing process before pushing the updated image out to all customers. This ensures that we avoid a “configuration drift” scenario where manual intervention leads to servers being configured inconsistently.

Kubernetes

At Kneat we are continuously looking for opportunities and technologies that have the potential to improve the service that we deliver to our customers. Kubernetes is such a technology, and its combination of a declarative deployment model (we define the services we require and Kubernetes ensures that they remain consistent with the definition) and use of immutable container images make it an excellent tool for delivering services to customers operating in regulated environments. Over recent releases we have moved some components of our solution to Kubernetes and we expect to move many more components over upcoming releases.

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Why companies are transitioning to the cloud

The trends of digital transformation and the International Society for Pharmaceutical Engineering (ISPE) (6) Pharma 4.0 initiative have laid the foundations for the move to the cloud. The transition has been accelerated by workplace restrictions imposed by Covid-19. Companies saw the benefits—such as reduced IT costs, increased flexibility and scalability, increased efficiency, improved security and performance—and innovation opportunities that cloud storage and computing were able to deliver. And this trend appears to be gathering pace. In a recent report published by Gartner, it has been estimated that by 2025, 85% of enterprises will have adopted a cloud-first principle (7).

The benefits of cloud automation for our customers

Cloud automation requires a huge amount of effort, but the rewards are in manifolds. For Kneat’s customers, as well as gaining the ability to perform complex tasks at the click of a button and reduce manual work, other benefits of cloud automation include:

     ✓  Fast deployment and qualification

     ✓  Quick and easy customization

     ✓  Increased control and flexibility

     ✓  Scale out capabilities

Fast deployment and qualification

At Kneat, we use cloud automation tools to build one version of a product. Then we qualify it, test it, and make sure that everything works as it should. Next, we build the tooling that allows us to build that version multiple times over. And because we are using infrastructure-as-code best-practices for our deployments—in place of manual interventions—we know that we are deploying the same thing over and over. All this means that we can deploy and qualify a customer environment faster than ever before.

Quick and easy customization

Because we use a single-tenant system and architecture, once Kneat Gx is installed, our software can be quickly and easily customized to best suit what is needed for each customer’s specific environment without having access to any underlying code.

Increased control and flexibility

All this empowers our users with more control and flexibility over their use of our software and results in a high level of engagement. Because tenants are in a separate environment from one another, they are not bound in the same way that tenants using a shared infrastructure would be, which leads to further benefits such as enhanced reliability, security (8), and backup ability.

Scale out capabilities

Cloud automation also provides our customers with seamless scale out capabilities. When it comes to the scaling challenge, when you see more users transacting on systems, there’s two ways you can deal with the issue—you can ‘scale up’ or ‘scale out’.

You can throw bigger hardware at the problem, or you throw more hardware at the problem. Bigger hardware is considered ‘scale up’ and more hardware is considered ‘scale out’. It is arguably better for a product owner to have the ability to scale out, because it gives the owner much more flexibility. It’s also less intrusive for customers, because there is no disruption to service or requirement to shut down to increase the size of the server.

At Kneat, we can react fast to scale the systems out as our customers’ use of the systems increases. We are continuously monitoring the performance of our systems and should we see a period of heavy usage of the Kneat Gx system—for example if they are going through big FDA audits and they need to pull a lot of documentation out of the application—we can quickly scale out the system to support that need.

In technical terms, scale out involves using Terraform to tell AWS to deploy additional server instances from the immutable server image. Traffic to all the instances is managed via load balancers which dynamically allocate user traffic to the additional instances when they come online. In simple terms, the system tells itself that instead of having two nodes it now has three nodes and inserts the first person into the first node and the second person into the second node, and so on. So that load gets distributed, and the spike in usage is accommodated, without any disruption to our service.

Thoughts to the future

The where, when, and how of validation for the life sciences industry is changing. Emerging trends in the validation industry, coupled with Pharma 4.0’s technological advances, have amplified the need for cloud-based validation solutions that digitize and transform inefficient, manual validation processes, and enable life sciences organizations to manage the increasing volume and complexity of validating new technologies with compliance assurance.

Kneat has invested heavily in cloud automation engineers, resources, and tools to deliver a world class and leading-edge SaaS digital validation solution. Our implementations range from a single validation process, in one location, to full deployments for multiple processes over many sites, with thousands of users. And our team is constantly working to improve the SaaS service that we deliver to our customers, by adding concepts such as container orchestration with Kubernetes, self-healing infrastructure, and automated delivery pipelines to enhance the performance of Kneat Gx and to smooth the delivery of new capabilities to our customers.

Today, Kneat’s cloud-based technology is trusted by eight of the world’s top ten life sciences companies and hundreds of validation engineers, compliance, and quality assurance professionals to digitize their entire validation lifecycle.

Discover how our proprietary software and platform, Kneat Gx, can help you to improve the speed, accuracy, intelligence, transparency, and management of your validation work now and into the future.

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About the Author

Sean Daffy is an accomplished IT leader with over 15 years’
experience delivering complex initiatives across industries
ranging from small start-ups to large MNC’s.

References

1. Pharma 4.0, [https://ispe.org/initiatives/pharma-4.0].
2. Amazon Web Services (AWS), [https://aws.amazon.com/].
3. HashiCorp Terraform, [https://www.terraform.io/].
4. HashiCorp Packer, [https://www.packer.io/].
5. Kubernetes, [https://kubernetes.io/].
6. The International Society for Pharmaceutical Engineering, [https://ispe.org/]. 
7. Why companies are flocking to the cloud more than ever, [https://www.businessinsider.com/cloud-technology-trend-software-enterprise-2021-2?r=US&IR=T].
8. Kneat Features and Functions, [https://kneat.com/features-and-functions/].