IT infrastructure - Software Solutions & Services - QbD Group

IT Infrastructure Qualification

In today’s fast-paced and highly regulated environment, ensuring the reliability and compliance of IT infrastructure is a growing challenge. IT infrastructure qualification remains as crucial as ever, from on-premises servers and networks to cloud-based systems.

Are you struggling to qualify your IT infrastructure to ensure it meets these demands? QbD Group offers IT infrastructure qualification expertise to help your company comply with the latest regulations.

What is IT infrastructure qualification?

SUPPORTING THE SHELF LIFE OF YOUR MEDICINAL PRODUCT

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.

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 and objectives.

This flexibility ensures that you can adapt to changing technological landscapes and regulatory requirements, providing a robust framework for maintaining compliance and operational efficiency.

The most common and recognized CSV approach is the GAMP5 methodology.

IT Infrastructure Qualification - Software Solutions and Services - QbD Group

Why partner with QbD Group?

EXPERT TEAM WITH YEARS OF EXPERIENCE

QbD Group 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.
Ensure your IT infrastructure is reliable and compliant with all relevant regulations. The first step towards data integrity!