ABSTRACT
With the rapid advancement of software development, the application of new technology in the GxP (Good Practice) area is limited due to the traditional validation approach. This hinders the industry's ability to effectively benefit from advanced technology for patient safety, product quality, and data integrity. The second edition of GAMP5 addresses this issue by advocating for a more flexible and patient-centric approach to validation. It encourages understanding the business and process, focusing on intended use, and adopting iterative and incremental (Agile) methods. Critical thinking is introduced as a mindset change that should be applied throughout the product life cycle to efficiently apply new technology while complying with regulatory requirements. This article suggests that regulated companies should focus on whether the selected system meets the intended use and leverage supplier expertise. It also highlights the importance of reducing repetitive testing, unnecessary documentation, and script-based verification in favor of demand-oriented verification methods. By embracing these principles, the GxP industry can accelerate the application of new technology and prioritize quality for the benefit of patients.
This article will focus mainly on one or two aspects regarding how the concepts of computerized systems assurance and critical thinking could be applied in CSV projects, with some touchpoints on:
- The increased importance of IT service providers, including cloud service providers;
- Evolving approaches to software development, including incremental and iterative models and methods.