Cloud Computing in a Regulated Environment

by Simone Ristori IT Infrastructure Qualification, CSV/CSA Advisor Engineer & Local Equity Partner @PQE Group

During the past two decades, we have seen an incredible evolution of technical solutions. The ways in which companies operated only 20 years ago are, today, totally obsolete.


Cloud computing is one of the possible solutions that gives companies, both regulated and non-regulated, the ability to improve their IT Systems in terms of high availability, performance and capability: when we speak about Cloud Computing, we mean on-demand availability of computer system resources, especially data storage (cloud storage) and computing power, without direct active management by the user. Large clouds often have functions distributed over multiple locations, with each location serving as a data center. Cloud computing relies on the sharing of resources to achieve coherence and typically uses a "pay-as-you-go" model which can help in reducing capital expenses, but which may also lead to unexpected operating expenses for unaware users.

Currently, companies have access to different single/multi-tenant cloud solutions where many systems used in daily critical operations are connected and should be able to continuously exchange different kinds of GxP critical information.

The business capability of having functionality of GxP solutions functionality in a regulated and compliant cloud environment allows for better potential digital transformation and governance, while also potentially allowing for more efficiency in the overall validation approach as well as incorporation of latest digital tools and technology trends.

In this context, it is crucial to define a strategic approach for the adoption of cloud-based solutions. Enterprises should follow a strategic approach to the adoption of cloud-based solutions to enhance business capabilities and scalability while maintaining compliance with applicable regulations.

In addition, increasing international regulatory requirements as well pressure for industry to be able to quickly react to complaints and adverse events, and maintain the overall ability to have quick accessibility and recovery of data is an essential driving force towards Cloud Computing driven by digital transformation and governance.

Want to know more?

PQE Group staff comprises experienced and skilled experts in multidisciplinary teams, available to support your company achieving the highest levels of safety for your systems.

Visit our Digital Governance page to know more or to contact us, and find the most suitable solution for your company.

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