IT Infrastructure Qualification
IT infrastructure qualification remains as crucial as ever, from on-premises servers and networks to cloud-based systems.
Need help qualifying your IT infrastructure? QbD offers IT infrastructure qualification expertise to help your company comply with the latest regulations.
Don’t hesitate to contact us for more information about our qualification services.
What is IT infrastructure qualification?
IT 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 (with a high degree of certainty) 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 21 cfr. Part 11, Annex 11. It is applicable to key GxP processes and provides reliability control and insight into the IT infrastructure used in a GxP process.
Why QbD Group?
QbD has years of experience with numerous projects in various GxP environments.
We are happy to help you:
- better understand which IT infrastructure is critical for GxP processes,
- better understand the functioning of your IT infrastructure (white-box approach),
- decide on the lifecycle and qualification approach,
The actual approach and life cycle you want to take to qualify your IT infrastructure is up to you.
The most common and recognized CSV approach is the GAMP5 methodology.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.