Infrastructure qualification in the cloud

The migration of life sciences organizations to cloud environments has been swift and sure.  There are many benefits to organizations that implement and deploy validated computer systems in the cloud environment such as cost savings, high-availability, improved operational efficiency, elasticity and much more. For validated systems environments, the principles of validation in the cloud still endure. Organizations must ensure that cloud service providers are following the same principles and best practices that are demanded in life sciences environments.

Prior to implementation of cloud technologies, IT organizations within life sciences companies controlled the system environment.  This was the purview of many IT organizations.  They control the technology that was acquired by their company, and they controlled every software application stored on this technology.  One of the benefits of using the cloud environment is that these mundane IT tasks are now the responsibility of the service provider.  Thus the cloud service provider must be rigorously scrutinized to ensure that they are performing behind the scenes in a manner that is acceptable to life sciences companies.

In the old days, validation engineers performed something that was called an installation qualification or IQ test script.  The purpose of the IQ was to confirm that software applications and hardware were installed according to its intended use.  I often hear many customers say, “I don’t have to conduct an IQ because I am on in the cloud”.   This is not entirely true.   While it is true that the way we used to conduct installation qualification is no longer adequate, it is not true that we can ignore the cloud environment where many of our validation environments sits.   This brings us to the need for infrastructure qualification in a cloud environment.  Is your cloud environment qualified?   Do we need to qualify the cloud environment?

This has been the subject of much discussion, not only within the Institute of Validation Technology but throughout many life sciences organizations that we are privileged to work with.  One of the questions that often comes up is how much validation due diligence is required and what we need to do with the environment in which our cloud applications sit?

There is a case to be made for some applications based on risk to qualify systems environments. I categorize the need for system environment qualification into two categories:

One – The environments that sit within highly structured environments such as AWS and Microsoft® Azure. It is very difficult to conduct a qualification of the physical environment in Azure or AWS due to the nature of those environments.   What we do in those environments is conduct an assessment of the provisioning of that environment to ensure that the system was provisioned in a consistent repeatable manner.

Two – The second type of cloud environment are those that are not large environments like AWS or Azure. These are private cloud environments by cloud organizations that may or may not have the regulatory rigor of AWS and Microsoft® Azure. These environments require qualification to ensure that they meet the rigorous standards necessary in a life sciences environment.  It is recommended that a installation qualification or provisioning qualification be conducted in these environments.

For this second type of environment, we can use cloud accelerators to provide more due diligence for qualifying the cloud environment.  Qualifying this environment does not need to be an expensive proposition.  There are cloud accelerators that provide documentation for the cloud environment that helps to accelerate your use of that environment.  This is a strategy that has often been repeated and is very successful in such environments.  The strategy includes full documentation of the configuration of the environment as well as other aspects related and unique to the applications that you are deploying.

You should be aware that installation qualification or qualification of the cloud environment is not obsolete with the cloud.  To help ensure that the environment consistently and repeatedly delivers the services you require, it is recommended that you use accelerators to qualify these environments to ensure that they function according to their intended use.

Vincent M. Bailey
Vincent M. Bailey
Chief Technology Officer, OnShore Technology Group

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