The Validation by Desing<\/a> Thinking is widely recongnized in 2020. However, it’s possible that new methodologies or concepts have emerged since then, or it could be a term specific to a certain organization or niche within the industry.<\/p>\n\n\n\n Validation by design thinking in the pharmaceutical industry, often referred to as “Validation 4.0”, is a shift in approach that adapts to the evolution of the industry. As Pharma 4.0\u2122 increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources[1].<\/p>\n\n\n\n In the pharmaceutical industry, validation typically refers to the process of establishing documented evidence that a system or process consistently produces results meeting predetermined specifications and quality attributes. This is crucial to ensure the safety, efficacy, and quality of pharmaceutical products.<\/p>\n\n\n\n “Design thinking” is a problem-solving approach that involves empathizing with end-users, defining problems, ideating solutions, prototyping, and testing. It is often applied in various industries to foster innovation and create user-centered products or processes.<\/p>\n\n\n\n If “validation by design think” has emerged as a term or concept in 2020, it might indicate an integration of design thinking principles into the validation processes within the pharmaceutical industry. This could involve a more user-centric approach to developing and validating processes or systems, with a focus on understanding the needs and experiences of end-users.<\/p>\n\n\n\n The goal of Validation 4.0 is to develop a cohesive, harmonized, integrated, holistic, risk-based approach for process performance qualification incorporating computer system validation that builds on the Pharma 4.0\u2122 operating model and includes the holistic control strategy, digital maturity, and data integrity by design[1].<\/p>\n\n\n\n This approach involves the adoption of quality risk management (QRM) and quality by design (QbD) principles and practices in validation. QbD is an integrated product design approach, which is also the cornerstone of the Pharma 4.0\u2122 holistic control strategy[1]. By using a risk-based approach, knowledge management, and QbD methodologies, the critical material, process parameters, and product quality attributes will be identified[2].<\/p>\n\n\n\n Validation by design thinking in pharma is to ensure that validation practices keep pace with the rapid evolution and paradigm shifts in the pharmaceutical industry, and Mivado GlobalPerformance will help you achieve that goal by implementing its 3-Stages Approach<\/a> in combination with Computer Software Assurance methodology<\/a>. Indeed, the validation execution should follow the principles of Quality and Data Integrity by Design [3]. The Validation activities should take place through the process design and product development that establish a correlation between the Definition of Requirements, Validation Process, and Data Lifecycle with a solid approach.<\/p>\n\n\n\n About the author<\/strong>: Kossi Molley, PMP., LSSBB., Chemist<\/a><\/p>\n\n\n\nValidation by Design Terminologies<\/h2>\n\n\n\n
Goal of Validation 4.0<\/h2>\n\n\n\n
Wrap-Up<\/h2>\n\n\n\n
References<\/h2>\n\n\n\n
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