Imagine this: you put in a new firewall for your good manufacturing practices (GMP) facility. A few months later, you realize it’s not working as intended. Perhaps the firewall allowed traffic that was not part of the network. How long has this issue been going on, and what problems has it caused? Yikes! This is why we have IT infrastructure qualification practices for GMP environments. Download our free eBook guide here for our best practices on the topic.

What is Qualification? 

Qualification is the process of ensuring that an installed system is operating as intended and with a high degree of quality assurance. This ensures that the production process the equipment supports is of high quality and that the integrity of the data generated is maintained throughout the lifecycle of the product/process. It’s required by the U.S. Food and Drug Administration (FDA) to verify that a system is operating as intended, quality standards are upheld, and the system is safe and secure. The FDA also validates that the system meets business and regulatory requirements when audited. 

IT Infrastructure Qualification Practices

Though the principles and guidelines surrounding the IT qualification process are very robust, interpreting and implementing GAMP5 and 21 CFR PART 11 guidelines are where most projects falter. Emphasis on testing low-value attributes, focusing on too many testing activities, ambiguity during requirements generation, and producing unnecessary documentation are some of the key reasons for IT Qualification not being effective. 

IT qualifications are a necessary and important step to ensure your systems are safe and operating as intended. Focusing on the quality of the computer software/infrastructure qualification will contribute to a quality-focused culture. This allows compliance to become a by-product of the culture, embedding it into the organization.  

In this eBook, we explore the importance of qualified systems, various requirements for an IT qualification, and how those requirements would play into the qualification process as a whole. Key topics include:

• Qualification Vs. Validation
• Need for IT Qualification
• System and Devices
• Phases Involved in an IT Qualification

Selecting a consulting partner who can support you through these quality-focused validation/qualification activities is a great way to get started.  To learn more about Clarkston’s validation and qualification services, please contact us today. 

Contributions from Nicole Sharp, Kennie Tepede, Dinesh Srinivasan