When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products. What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS). Running applications in the cloud is a relatively new concept for many industries, but it has many benefits, chief among them the ability to replace up-front capital infrastructure expenses with low variable costs that are scalable with usage.
For FDA-regulated industries, there are concerns about how cloud computing complies with GxP regulations, particularly 21 CFR Part 11. AWS has entered this arena, and has numerous customers that have developed, validated, and operated all or part of their GxP systems using their products. AWS recently engaged Lachman Consultants to collaborate in development of a GxP whitepaper that deals specifically with this issue. The announcement of this partnership states “[t]his whitepaper provides guidance for using AWS Products in the context of GxP and the content has been developed in conjunction with AWS pharmaceutical and medical device customers, as well as software partners, who are currently using AWS Products in their validated GxP systems.”
As consultants with clients in the FDA-regulated industry, we have found that, in the past few years, one of the most common questions we get from our client base is about cloud solutions that are Part 11 compliant. Clearly, cloud computing is a significant trend in the industry, and we are very proud to have contributed to a major initiative with one of the largest providers of cloud computing solutions.