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Want to Utilise the Cloud for GxP Applications?

Zener Engineering Services Ltd • 25 October 2020

The amount of electronic information (data) computer systems generate continues to grow significantly. Industry is always looking for better, cheaper and faster solutions. Outsourcing to specialised firms who can provide IT solutions more efficiently, who can leverage technology to improve information handling, is increasingly attractive and of interest to GxP companies.

Cloud solutions in a GxP environment present a number of regulatory challenges.

Zener Engineering Services can determine and document the validation approach to be adopted depending on the inner workings of the cloud-based application. Depending on the cloud service model, the vendor may be responsible for some of the validation activities. ZES can determine and document boundary lines, roles and responsibilities to help ensure a successful project.

Zener Engineering Services validation engineers will help ensure system requirements are tested, are suitable and are to the required regulatory standard.

FDA / MHRA expectations do not change in an outsourced environment,
including the utilisation of a GxP cloud solution.

Changes to the chain of command, roles and responsibilities, for a GxP cloud solution,
must be documented by the GxP Company.

Cloud solutions in a GxP environment present a number of regulatory challenges. Global regulators are interested in the growing utilisation of cloud environments. Regulators are not averse to cloud computing, but like all new “hot topics” they need to understand the risks and required controls, as does the GxP Company and its Suppliers.

ZES can determine and document the validation approach to be adopted depending on the inner workings of the cloud-based application.

The cloud solution provider’s involvement must also be taken into consideration when determining the activities required during the validation life activity of a cloud-based solution. Depending on the cloud service model, the vendor may be responsible for some of the validation activities. ZES can determine and document boundary lines, roles and responsibilities to help ensure a successful project.

ZES validation engineers will help ensure GxP cloud system requirements are tested,
are suitable and are to the required regulatory standard.

Contact ZES with all your GxP Cloud concerns and requirements.