Infrastructure Qualification is the process of demonstrating that IT components developed to be fit for their intended use can meet specified requirements and that the system’s fitness state is maintained throughout each point in the system’s life cycle.
In other words, it proves that IT components, such as servers, clients, and peripherals, can meet the specified requirements for the various platforms, whether specific or generic in nature.
IT infrastructure qualification is a regulatory requirement according to regulations like ISMS, 21 CFR Part 11 and Annex 11. It is applicable to key GxP processes and provides reliability control and insight into the IT infrastructure used in a GxP process.
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Better understand which IT infrastructure is critical for GxP processes,
Better understand the functioning of your IT infrastructure,
Decide on the lifecycle and qualification approach and
Ensure your IT infrastructure is reliable and compliant with all relevant regulations.
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