US Government Adopts Cloud and Agile…It’s the Medidata Way!
To meet the rapidly evolving needs of regulated companies, many technology suppliers have adopted advanced development, implementation and hosting methods. For instance, Software-as-a-Service (SaaS) providers like Medidata have replaced the traditional Waterfall software development approach with an Agile development approach, along with greater dependence on automated testing tools. Furthermore, as regulated companies outsource more and more of their non-core operations, technology suppliers do it, too. In Medidata’s case, this means outsourcing hosting operations to Infrastructure-as-a-Service (IaaS) and Platform-as-a-Service (PaaS) providers, as well as outsourcing other generic systems and services—for example, source code management, electronic document management system (eDMS), learning management system (LMS)—to other SaaS providers.
Before you say, “But the regulators will never accept these new technologies!” you are encouraged to consider the following: In mid-2012, the US Government Accountability Office (GAO) identified a number of practices and approaches as effective for applying Agile software development methods to IT projects. Government officials who have used Agile methods positively commented on the effectiveness of these practices. More recently, in mid-2013, the US Federal Risk and Authorization Management Program (FedRAMP) announced its approval of a cloud technology provider for use in government business, under an assessment sponsored by the US Department of Health and Human Services (HHS). Although these notices are specific to the US and do not explicitly reference the FDA, it is not a great leap to envision other government entities within the US, as well as other healthcare regulators worldwide, recognizing the value, and in fact the necessity, of considering new technologies as they look to improve their own operations. What are your thoughts on the growing adoption of cloud-based technology and Agile development?
 “SOFTWARE DEVELOPMENT: Effective Practices and Federal Challenges in Applying Agile Methods,” U.S. Government Accountability Office (July 27, 2012)
 Hayley Tsukayama, “Amazon Web Services gets government approval for federal cloud,” The Washington Post (May 21, 2012)
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