In the ever-evolving landscape of regulatory compliance, pharmaceutical, biotechnology, and healthcare industries are constantly challenged to enhance their processes while ensuring adherence to stringent quality standards. The advent of cloud technology has brought forth transformative solutions, which present their own regulatory challenges in the GxP environment.

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 and this 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.

The latest GxP Cloud Project Training Video from Zener Engineering Services Ltd serves as an initial project introduction of the considerations for Cloud computing in the GxP environment.

Unlike most traditional training methods that often rely on theoretical scenarios, in this GxP Cloud Project Training video, real-life situations, based on the many years' experience of Zener Engineering Services Ltd Consultants, are utilised to illustrate the concepts and potential consequences of non-compliance and poor project management.

Human brains are wired to process visual information more rapidly and retain it longer than text-based content. This training video capitalises on this fact by delivering information through a combination of visual and auditory elements. This enhances comprehension and retention, making it an ideal medium for teaching complex concepts, demonstrating tasks, and introducing GxP Cloud.

Every company has unique training requirements based on its industry, products, services, and internal processes. Training videos can be customised to address these specific needs. By creating modular videos that cover different aspects of training, companies can tailor the content to match the roles of different employees, ensuring relevance and effectiveness.

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.