Life Sciences

GxP in the AWS Cloud

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SHARE: GxP in the AWS cloud: The compliance and efficiency benefits of rethinking regulated workloads 5 with them. As importantly, they generate extensive documentation on their GxP systems to demonstrate such control to auditors. The next step is to automate the monitoring of the system itself. Such monitoring is needed to ensure the cloud services and processes are functioning properly. To do this, Merck created a checker of continuous compliance. This checks if the right email addresses are used for alerts, confirms all AWS services are enabled, tests if Config is connected to the right source of logs and otherwise validates that the environment is consistent with Merck's requirements. The checker runs periodically and on demand. Merck uses it to check each environment before it is released and each day thereafter. Errors trigger notifications. Each run generates an archive for historical auditing. Merck has paired this automated checker with manual, periodic assessments of its cloud. As the cloud has no dedicated physical resources, Merck foregoes on-site audits in favor of other ways of checking the system. These include annual assessments of support tickets and performance issues. Merck also performs reviews of the AWS environment and checks its partner's industry certifications are up to date. MAKING FURTHER IMPROVEMENTS These tasks are part of a dwindling list of manual jobs involved in running GxP workloads in the cloud. As companies have become more comfortable with regulated workloads in the cloud, they have realized efficiency gains and compliance benefits by switching from manual to automated checks and controls. This is an ongoing process. Merck is exploring whether the system can self-correct, rather than just informing people of a problem and letting them implement the fix. This would further reduce the need for active management of the cloud environment. Companies will approach such new ways of working cautiously. But the experience of moving GxP workloads to the cloud so far suggests companies can quickly eliminate barriers to adoption. The companies that engage with vendors and regulators to drive forward such advances and seize existing opportunities will be rewarded with systems that provide more control for less effort than ever before. l For over 10 years, Amazon Web Services has been the world's most comprehensive and broadly adopted cloud platform. AWS offers over 90 fully featured services for compute, storage, networking, database, analytics, application services, deployment, management, developer, mobile, Internet of Things (IoT), Artificial Intelligence (AI), security, hybrid, and enterprise applications, from 42 Availability Zones (AZs) across 16 geographic regions in the U.S., Australia, Brazil, Canada, China, Germany, India, Ireland, Japan, Korea, Singapore, and the UK. AWS services are trusted by millions of active customers around the world – including the fastest growing startups, largest enterprises, and leading biotechnology, pharmaceutical and medical device companies – to power their infrastructure, make them more agile, and lower costs. To learn more about AWS in biotech and pharma, visit

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