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May 10, 2016

My previous post on pharma innovation emphasized on the right mix and balance of cloud adoption models, with adequate assurance validations and controls. As promised, lets build on and understand with a real-life pharma business scenario – a web-based, globally accessible CRM application for a Life Science company, hosted on cloud infrastructure. As worldwide business users access the application, a load balancer manages the incoming requests and traffic, balancing the load across web, application and database servers. Sounds like a typical application landscape?

Now lets add a dose of intelligence to this. What if, depending on the surge in application usage and network traffic, the load balancer, auto-scales itself (and also other network resources), and ensures continuous application availability without manual intervention. Lets take things one step further. What if an existing server goes down due to an untoward incident? Needless to say, continuous application availability and adequate data security must be ensured. To ensure prompt and adequate disaster recovery, the architecture and data must also be replicated. How about hot-swappable on demand options for moving applications to another server? Thats cloud-enabled IT intelligence at work. But hold on. Theres a catch.

Flawless working of this cloud-driven intelligence requires continuous testing at all levels. A paradigm shift from the traditional testing approach that focuses on functionality, cloud testing also emphasizes on non-functional testing at the infrastructure level to ensure seamless service delivery. In addition to the standard functional tests that assure application functionality, cloud testing must also assure:

Disaster Recovery: Tests to ensure continuous availability, prevent network failures, check load response towards preventing breakdowns, system failures and data loss

Scalability: Clearly defined auto-scaling configurations, that add intelligence and adequately equip cloud resources to scale up or down, automatically, and on-demand

Performance: Measuring and managing network latency, performing load and stress tests, and balancing workload, to ensure minimum response time, even when there’s high traffic load

Security: Ensuring authorized access to user sensitive information, to protect data integrity and user privacy

Availability: Continuous monitoring of the cloud service, which in turn, ensures continuous availability, in line with accepted and documented Service Level Agreements (SLAs)

Validating Cloud for Life Sciences

While these are important assurance components for cloud deployment, pharma cloud strategies cannot ignore the regulatory compliance aspect. In fact, stringent regulatory norms are the main reason for slow cloud adoption in pharma. The involvement of multiple cloud service providers and vendors reduces the learning curve, and eases deployment, but it also introduces data access and privacy vulnerabilities, and necessitates robust and rigorous assurance controls at all levels. Cloud service providers must not only appreciate these regulatory requirements, but also integrate adequate internal and external controls in life sciences solutions.

Heres an indicative to-do list for cloud service providers:

  • Incorporate 21 CFR Part 820 Good Manufacturing Practices (GMP) for devices
  • Incorporate 21 CFR Part 11 predicate rules on R&D, drug manufacturing, device manufacturing, etc.
  • Demonstrate regulatory compliance through adequate privacy checks and regular reporting
  • Identify risks and mitigation controls for infrastructure and program access, development and change
  • Classify systems based on their risk profile
  • Implement data classification policies and procedures

These controls are a good start, but the industry has a long way to go. With cloud adoption still in its nascent stage, and the switchover process expected to take longer than other industries, now is the right time for pharma to drive mindset change, and plan cloud strategies and investments that will drive unprecedented benefits in the future. It is only a matter of time before the cloud becomes a way of life in pharma. Early movers will reap the rewards and stay ahead of the curve (and competition!). Why? Because these initiatives will quickly transform into business benefits.

Vignesh Karthick is an ex TCSer. He started his career as a Server administrator in a cloud infrastructure environment. 


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