By Cormac O’Leary and Imelda Mason
Before we get into the meat of this post, let us take a step back and look at “What is Cloud?” No they are not just “Cirrus” and “Cumulus”, they are computing services that are delivered and consumed in real-time over the internet.
On-demand self-service. A consumer can automatically provision computing capabilities such as server time and storage as needed without requiring human interaction with each service provider. Examples of resources include storage, processing, memory, and network bandwidth.
Broad network access. Capabilities are available over the network and accessed through standard devices (e.g., mobile phones, tablets, laptops, and workstations).
Measured service. Cloud systems automatically control and optimize resource use by leveraging a metering capability appropriate to the type of service (e.g., storage, processing, bandwidth, and active user accounts). Resource usage can be monitored, controlled, and reported, providing transparency for both the provider and consumer of the utilized service.
Rapid elasticity. Capabilities can be elastically provisioned and released, in some cases automatically, to scale rapidly up and down in line with demand. To the consumer, the resources available for provisioning often appear to be unlimited.
Resource pooling. The provider’s computing resources are pooled to serve multiple consumers using a multi-tenant model, with different resources dynamically assigned and reassigned according to consumer demand.
With these characteristics we can then construct three distinct Cloud Service Models:
Cloud Service Models
In this article we are concentrating solely on Infrastructure as a Service, which is comprised of highly automated and scalable compute resources, cloud storage and network capability. Customers that consume IaaS no longer need to invest in the capacity planning or the physical maintenance and management of infrastructure. IaaS is the most flexible cloud computing model and allows for automated deployment of servers, processing power, storage, and networking.
So we have you sold on IaaS, but where does this service model fit in the Life Sciences sector?
It’s fairly simple…
Annex 11 Computer System
“The application should be validated; IT infrastructure should be qualified”
21CFR Part11 Electronic Records and Electronic Signatures
Cloud infrastructure is considered part of the regulated system. Companies shouldn’t forget to qualify their infrastructure. What are ‘systems’ in ‘computer or related systems’ in 211.68 as per the regulations. This specifically calls out ‘Cloud Infrastructure’.
At Compliant Cloud we ensure that our Cloud Infrastructure is Qualified (QIaaS), helping our Life Science customers to be and remain compliant.