• There are no suggestions because the search field is empty.
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 like21 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

 

IT Infrastructure Qualification - Software Solutions and Services - QbD Group (2)

Related content

preview_image
Whitepaper

How to keep computerized systems in the operational phase

Ensure compliance and efficiency with best practices for maintaining computerized systems in the operational phase. Download our expert whitepaper now!
preview_image
Webinar

From Requirements to Code: a unified MDSW development cycle that covers all requirements

Watch our webinar on demand to master medical device software development. Learn about IEC standards, cybersecurity, AI integration, and FDA expectations.
preview_image
Whitepaper

Mobile health on the rise: exploring the regulatory landscape for reimbursement

This whitepaper will help you navigate the maze of the DTx regulatory environment, highlighting several important countries and regulations.
preview_image
Whitepaper

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

Learn how to comply with GMP, GCP, and GLP regulations using the GAMP 5 Software Validation Approach. Download the whitepaper for more insights.
preview_image
Blog

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) under the MDR: Ensuring safety and performance

With the introduction of the Medical Device Regulation (MDR), the...
preview_image
Blog

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

It shouldn’t be a surprise that today, “Near-Patient Testing (NPT)” and...
preview_image
Blog

When does Annex XIV apply in Performance Studies, and what key documentation is needed for compliance?

In the European regulatory landscape, conducting performance studies for in...
preview_image
Blog

What are the requirements for IVD Clinical Performance Studies Under IVDR and ISO 20916?

What is a Clinical Performance Study? A clinical performance study...

 

contact-mail

Get in touch

Ready to ensure your IT infrastructure meets regulatory standards and supports your GxP processes?

Let’s work together to secure the reliability and integrity of your IT systems. Contact us now!

Circles_get in touch_Software solutions & services-1