Begin with the End in Mind: Back to the Focus of Quality - About the Application of GAMP5 Ed02 in CSV Projects

by: Tina Lan (Tina), Director @PQE China


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. 

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With evolving technology, software development has been advancing at high speed. However, the application of new technology in the GxP area is constrained as the validation approach has been confined to the classic but traditional V model. Consequently, the most advanced technology can hardly benefit the industry effectively for patients. In this case, the current situation in not in line with the goal of the GxP regulations to safeguard patient safety, product quality and data integrity. 


Therefore, the second edition of GAMP5 emphasizes the following points: 

The GAMP specification and verification approach is not inherently linear. Rather than simply producing documentation for documentation’s sake with a linear validation approach, the verification should be based on the understanding of the business and process, and the testing should focus on the intended use with more flexible approaches.   

In GAMP5 Edition 02, it is encouraged that the patient-centric and risk based approach should be adopted against a primarily compliance-driven approach, which has been applied with excessive documented test evidence such as, in some cases, a screenshot for every single step.  

Meanwhile, with the reinforcement that the supplier quality system and documentation may be leveraged, it also provides guidance on how to support iterative and incremental (Agile) methods and the application of new technology (e.g., software tools, blockchain, ML/AI, etc.). 

This is why Critical Thinking is introduced here as an important concept in this edition, starting from a mind-set change, and how this should be applied to all stages of the product life cycle in order to fulfil the desire of applying the new technology efficiently and in compliance with regulatory requirements. 


As an industry player, how can this apply to the CSV projects? 

First, following the trend of the IT Service Provider’s development, the focus of supplier and system selection by the regulated company should be on whether the system can meet the intended use. With the development of technology, we have more cloud-based suppliers (XaaS: Infrastructure as a Service, Platform as a Service and Software as a Service). The implementation of such systems relies on the standard and collaboration between suppliers and the regulated company, especially the supplier assessment, supplier documentation to be leveraged, completed tests and GxP impact assessments to leverage on the supplier’s expertise in business process and GxP regulations.  

The expectation is to transform the current test-centric situation, which primarily ends with the owner's linear test results, into a demand-oriented verification mode that emphasizes the owner’s and supplier's full understanding and evaluation of business processes, requirements and acceptable standards, reduces repetitive testing and unnecessary documentation, and truly realizes the risk-based methodology objectives. 

The guide provides suggestions for IT service providers and system design of GxP computerized systems. To reduce the efforts of product management and simplify the update process, the supplier should aim to develop customer requests for the new functions to be put into the mainstream product offering for the wider user base when feasible, keeping the development of new or amended features within the supplier’s development life cycle rather than creating special versions for individual customers. Critical thinking emphasizes that the regulated company should access or leverage the suppliers based on the intended uses, which means the quality systems and deliverables of the supplier, including the coherent development and testing approaches, will reduce the validation efforts of the regulated company significantly. 

In addition, the new edition of GAMP5 also integrates more diverse testing methods based on critical thinking, such as supplier testing, unscripted testing, scripted testing (manual or automated), and user acceptance testing (UAT). If done in cooperation with the agile development approaches, exploratory testing, automated test tools and other methods can be introduced to ensure the robustness and completeness of testing. This leaves the regulated companies and suppliers more space in terms of verification methods and test design. As a result, it releases the stress on the burden of scripts and test documentation and allows for the focus to be on confirming whether the system is fit for the intended use. 

Accelerating the application of new technology in GxP industry and enabling the manufacturing process and benefiting patients cannot be achieved without the joint efforts of regulated companies, suppliers, and regulators. The compliance cost and focus should be on confirming the right fit for the intended use. In this way, we can start with the end in mind; focusing on quality for the vision of the life science industry. 

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