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GxP in the AWS cloud: The compliance and
efficiency benefits of rethinking regulated workloads
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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
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