GxP Cloud Or GMP Cloud Applications

The typical Cloud applications provider tends to have a diverse customer base, which is mostly non-GxP. Therefore Cloud applications providers tend to have more power than GxP companies to dictate how the quality aspects of the GxP Cloud applications business should run, which must be considered.

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, and who can leverage technology to improve information handling, is increasingly attractive and of interest to GxP companies.

FDA MHRA EMA validation 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.

Need Help With GxP Cloud Validation From An Experienced Consultant?

GxP Cloud Solutions Validated By ZES +

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.

The ZES Validation Consultant can determine and document the validation approach to be adopted depending on the inner workings of the cloud-based application, in line with the regulations.

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 successful cloud projects.

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

GxP Cloud Projects Managed By ZES

Some large cloud providers refuse to provide transparency on processes, which they consider as “proprietary” information. This does not lend itself to GxP validation principles.

Please watch the ZES Cloud Computing videos to understand how ZES can help your company.