VMworld 2011: Regulators do not understand the cloud, says pharmaceuticals CTO

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VMworld 2011: Regulators do not understand the cloud, says pharmaceuticals CTO

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Regulators are years away from understanding the cloud, according to Stephen Speirs, chief technology officer at Charles River Labs, a contract researcher for major pharmaceutical and biotechnology companies.

 

Speaking during a panel session at VMworld in Copenhagen, Speirs, who has been using VMware for three years, said he wanted to be in a position where the default position of the company would be to put IT in the cloud. But the pharmaceutical business is heavily regulated. In particular, the US Food and Drink Administration (FDA) requires companies to provide serial numbers of servers for computer system validation.

He said the regulators did not really understand the cloud. "We need to educate regulators that we can still maintain control, even if the server is in the cloud. It could take a while before they really understand it."

According to Speirs, regulators and regulated companies need to move to a risk-based approach to compliance. "We need to build a level of trust in how the provider [of cloud services] controls its environment."

One approach that may satisfy regulators in the future, according to Speirs, is for the CIO to visit the supplier's datacentre to witness how it is run and incorporate this information into a system validation plan for the purposes of regulatory compliance.

In the meantime, Charles River Labs is being careful which systems it puts into the cloud to avoid infringing FDA regulations. "We have run a pilot with our IT helpdesk application to see how we could work with an external cloud provider, looking at how we would manage a supplier and service levels," he said.

Since the application is the IT helpdesk, there are no privacy concerns that could affect regulatory compliance. Another benefit of using the helpdesk is that it is an IT function, so IT has full control of the project.

 


 

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