4 Benefits of Qualifying Your Infrastructure

Regulations state that IT infrastructure should be qualified, but what other benefits can you see from qualifying your infrastructure? Nicola Brady breaks it down.

When you work in a regulated industry, the reason that a company qualifies its IT infrastructure is pretty obvious, right?  It is a regulatory requirement set forth in Annex 11; “The application should be validated; IT infrastructure should be qualified”. 

But this is not the only reason to qualify your infrastructure. In fact, outside of the compliance and regulatory requirements, the process of IT infrastructure qualification provides many other benefits.  

To understand these benefits, we first must understand what it means to qualify IT infrastructure: 

Infrastructure Qualification can be defined as “the process of proving and documenting that the infrastructure hardware and / or software is properly installed and works as expected.”  When the infrastructure is on-premise or on-cloud, qualification is achieved through the execution and documentation of the following phases: Requirements > Design > Build > Test > Release. 

The benefits of qualifying IT infrastructure can be presented under the following four headings: 


We have already touched upon the primary reason that companies qualify their infrastructure.  Because the regulations require it, specifically, Annex 11: Computerised Systems.  The execution of a comprehensive, documented qualification process ensures that the regulatory and specific compliance requirements are satisfied.  


The execution of a structured, documented qualification process ensures that the IT infrastructure is in a state of control.  It supports that all of the IT components associated with the IT infrastructure are installed and operating as expected and are fit for intended use.  It also provides assurance that information and data processed and / or stored by the IT infrastructure is safe and integral and that access to the IT infrastructure is controlled and appropriate to preserve this safety and integrity. 


Through involvement in the qualification process, strategic personnel responsible for the administration, support and maintenance of the IT infrastructure have the benefit of extensive knowledge and understanding of the IT infrastructure and its IT components.  Furthermore, where you outsource to an external service provider for cloud infrastructure, you can be assured that the knowledge and expertise is present through their involvement and understanding of the qualification process. 

“IT infrastructure should be qualified, but not just to satisfy regulatory requirements”


The qualification process ensures the establishment of ownership, support processes and ongoing maintenance and monitoring of the infrastructure.  These support processes include change and configuration management, incident management, user access review to name but a few. Support processes along with ongoing maintenance and monitoring help to preserve the infrastructure in a qualified state.  

In summary, by qualifying your IT infrastructure you end up with a robust IT infrastructure with built in mechanisms for its control and management. IT infrastructure should be qualified, but not just to satisfy regulatory requirements. 

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Nicola Brady

Nicola Brady

Nicola Brady is a Senior Quality Assurance Specialist with Odyssey VC and Compliant Cloud. She specialises in articles about Quality and Data.

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