IT Infrastructure Qualification
Demonstrate IT component fitness for GxP compliance
In today's highly regulated environment, ensuring the reliability and compliance of IT infrastructure is a growing challenge. QbD Group offers IT infrastructure qualification expertise to help your company comply with the latest regulations.
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 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.
Tailored approach
Flexible service
The actual approach and life cycle you want to take to qualify your IT infrastructure is up to you, allowing for a tailored strategy that aligns with your specific business needs. The most common and recognized CSV approach is the GAMP5 methodology.
Regulatory compliance
IT infrastructure qualification is mandated by 21 CFR Part 11 and Annex 11 for GxP processes.
Operational reliability
Ensures your IT infrastructure is reliable and performs consistently within regulated environments.
Adaptability
This flexibility ensures you can adapt to changing technological landscapes and regulatory requirements.
Why QbD Group
Your trusted partner
QbD Group has years of experience with numerous projects in various GxP environments. We 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.
Ensure your IT infrastructure is reliable and compliant with all relevant regulations
the first step towards data integrity.
Let's talk Software
From system validation to digital transformation, our software experts are ready to support your journey.