Issue link: https://read.uberflip.com/i/1182456
Amazon Web Services – Using AWS In GxP Systems January 2016 Page 4 of 34 1 ABSTRACT In 2006, Amazon Web Services (AWS) began offering IT infrastructure products to customers in the form of web services, now commonly known as cloud computing. Today, AWS provides a highly reliable, scalable, and low-cost infrastructure platform that powers hundreds of thousands of businesses in 190 countries around the world. Some of the key benefits of cloud computing are the opportunity to replace up-front capital infrastructure expenses with low variable costs that scale with usage and allow customers to spend more time on their core activities and less time on undifferentiated IT tasks. With the cloud, organizations no longer need to plan for and procure physical devices and IT infrastructure weeks or months in advance. Instead they can instantly spin up hundreds or thousands of virtual machines using automated deployment tools and methods that deliver results faster while ensuring more consistency of controls and less manual errors. In order to benefit from adopting AWS Products, organizations with Good Laboratory, Clinical, or Manufacturing Practices (GxP) compliance requirements and their auditors will need to acquire new skills and consider changes to GxP policies and procedures that focus on making IT compliance more agile, automated, and security-oriented. This 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. In order to ensure the suitability of the content, AWS took the additional step of engaging Lachman Consultant Services Inc. (Lachman Consultants) to review and contribute to the approach outlined in this whitepaper. Lachman Consultants is one of the most highly respected consulting firms on FDA and international regulatory compliance issues affecting the pharmaceutical and medical device industry today. Lachman Consultants has extensive experience working with companies specifically on matters pertaining to the establishment and development of GxP systems, including GxP guidelines in support of maintaining regulated data in a cloud environment. For further information on Lachman Consultants, visit www.lachmanconsultants.com. Nevertheless, it remains incumbent upon AWS customers to consult with their own advisors to ensure that their GxP policies and procedures are suitable for current IT, software, and security practices using AWS Products.