In the GxP world, validated computer systems are an important topic. But what is validated software, and why is it so crucial? In highly regulated environments, such as in life sciences, food or drug registration and production, software must adhere to the quality assurance framework which requires for critical Computer Systems an implementation process consisting of installation qualification (IQ), operational qualification (OQ) as well as performance qualification (PQ).  

What is software validation? 

In short: Software validation evaluates whether the software meets all stakeholder requirements and which does not only include the end users working with the application, but also the company's IT security concepts, business continuity aspects as well as the company’s quality requirements. To verify this, the validation process includes functional, security, and performance tests to ensure that the software's actual implementation meets all stakeholder’s requirements.  

Challenges of validating software 

Although computer system validation is essential in the pharmaceutical industry, some challenges must be overcome. Many companies shy away from the effort involved in validation - and we understand that. Primarily, validating software is complex and can be expensive as it requires various resources. In addition, the regulations presented by different authorities (e.g. FDA, MHRA) have been raising the standards for computer system validation, especially in the IT security area over time, which means that companies must adapt their validation processes accordingly in a continuous manner. 

Why is software validation necessary? 

Computer System Validation is a risk-reducing measure to ensure: 

  • Safety and Reliability 
    Validation ensures that the company’s requirements towards data integrity and IT Security are met. During the validation process, business continuity as well as disaster recovery should be addressed, since software failure or data breaches/loss can have serious consequences. 

  • Improved operational processes 
    Validation ensures that the end users daily business process are correctly covered and effectively supported by the computer system. 

  • Compliance with relevant regulations 
    As mentioned earlier, critical computer systems are required to be validated in heavily regulated environments before further use. By documenting the validation process in detail, companies can avoid findings during audits and penalties/warning letters by authorities. 

In conclusion, computer system validation is one of the critical aspects of the regulatory environment. It helps make computer systems safer and more reliable and verifies that they fulfill its intended purpose. Thus, it is crucial to ensure safety, quality, and compliance.  

Did you know, that, among others, EXTEDO provides a broad range of Computer System Validation (CSV) services to support client systems? Have a look at our website if you would like to find out more about CSV and how our validation experts can support you.



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