The trend in the pharmaceutical industry is also moving towards cloud computing. Financial but also organizational advantages speak for the cloud. At the same time, however, potential dangers and regulatory restrictions should also be taken into account.
IaaS, PaaS, and SaaS are abbreviations and different grades (or service models) of various cloud service provider (CSP) offerings. “aaS” always stands for “as a Service”. In XaaS, the X is a placeholder for either I, P, or S, meaning Infrastructure, Platform, or Software. Sometimes, XaaS is also called “Anything as a Service” or “Everything as a Service” and can take very specific characteristics like “High Performance Computing as a Service (HPCaaS)” or “Artificial Intelligence as a Service (AIaaS)”.
CSPs offer various services and benefits depending on the basic service model, and the tasks to be executed may shift accordingly.
- For computerized systems or applications that are being operated traditionally on premise, the regulated company (or its IT department or IT service provider, if outsourced), is responsible for all tasks related to computerized system validation (CSV).
- IaaS: If the infrastructure is provided and managed by the CSP, the model is called IaaS. Here, the tasks and responsibilities of the regulated company start with the installation of the operating system.
- PaaS: At the next level, the CSP takes over installation and operation of both, infrastructure and operating system. The regulated company steps in with the configuration of the runtime environment.
- SaaS: For this model, the CSP provides and operates the configuration of the runtime environment and the application on top of infrastructure and operating system.
In other words, the activities shift from user (regulated company as client) to cloud service provider (supplier). However, the responsibility for validation and operation of the application and all related topics like data integrity, data privacy, data security etc. remains with the regulated company.
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