APR January/February 2022 - 48

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MANUFACTURING
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Lately a third model, Hybrid cloud, appeared and it is a combination
of public and private cloud services, maintained by both internal
and external providers and with orchestration between the two. This
model enables organizations to use the benefits of the public cloud
for certain workloads, such as to accommodate demand spikes, but
also maintain their own private cloud for sensitive, critical or highly
regulated data and applications. There are several hybrid cloud
benefits - such as flexible deployment options, greater cost control
and the ability to move between environments.
A related option is a multi-cloud architecture, in which an enterprise
uses more than one cloud. Most often it refers to the use of multiple
public clouds. Depending on its needs, a business might choose to use
both the hybrid and multi-cloud models.
The cloud architecture can be categorized by service model. These are
the three most common service models:
*
Infrastructure as a Service (IaaS), in which a third-party
provider hosts infrastructure components, such as servers and
storage, as well as a virtualization layer. The IaaS provider offers
virtualized computing resources, such as VMs, over the internet
or through dedicated connections.
* Platform as a Service (PaaS), in which a third-party provider
delivers hardware and software tools - usually those needed for
application development, including operating systems - to its
users as a service.
* Software as a Service (SaaS), in which a third-party provider
hosts applications and makes them available to customers over
the internet.
The promises of cloud computing are certainly considerable:
extremely fast and flexible solution delivery, on-demand scalability,
high-demand business continuity services with easy solutions for
backup and archiving. All this, and at a cost that is considerably
lower than the traditional internal setup. But while providing
the capabilities and adoption levels, can the cloud services
simultaneously meet the regulatory compliance needs that are
core to the pharmaceutical sector?
Despite the promises of efficiencies and flexibility, the adoption of
cloud solutions at an enterprise level in the regulated environment
is very slow. Our understanding of how to operate today has been
shaped based on regulations, such as FDA Part 11, Eudra Lex - EU Annex
11, chapter 7 of the EU GMP Guide and industry guidances like ISPE
GAMP®. We are all aware that our current regulations are a bit behind
the technology and that may also impact the reception of new tools
and services. We are waiting for specific guidance around a technology
that is still evolving. The absence of those specific regulatory guidelines
for the cloud, in combination with a very conservative mindset and
a historically risk-averse culture, is slowing down the pharmaceutical
industry in the adoption of new technologies. The never-ending
dilemma of innovation versus compliance.
Figure 1. The partnership that a regulated company and a service provider must prepare.4
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| January/February 2022

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022

APR January/February 2022 - Cover1
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