{"id":1384,"date":"2020-12-21T16:30:00","date_gmt":"2020-12-21T16:30:00","guid":{"rendered":"https:\/\/www.feed4ward.com\/?p=1047"},"modified":"2020-12-21T16:30:00","modified_gmt":"2020-12-21T16:30:00","slug":"gamp5-with-agile","status":"publish","type":"post","link":"https:\/\/dev.codethisfor.me\/feed4ward\/2020\/12\/21\/gamp5-with-agile\/","title":{"rendered":"Is GAMP\u00ae5 compatible with agile development?"},"content":{"rendered":"\n

As engineers and project managers, we like certainty. Detailed clear requirements, defined up-front, against which we can design, cost and plan. However the modern world is a dynamic, fast-changing place. Technological advances and changing customer needs mean that we sometimes need to adapt and innovate throughout the lifetime of a project. But can we combine GAMP5 and agile development?<\/p>\n\n\n\n

The traditional waterfall model of project delivery, although still very valid in many cases, must be challenged as we find innovative new ways of delivering quality and success in a fast-changing environment. As we focus on the needs of the customer rather than what is easiest for the project delivery team, this might mean that success criteria are based on value and quality rather than cost, time and scope. Delivery and product acceptance might need to be incremental rather than all-at-once.<\/p>\n\n\n\n

Changing Mindsets<\/h3>\n\n\n\n

ISPE – International Society for Pharmaceutical Engineering<\/em><\/a> – has been considering the implications of rapid development on the GAMP5 model, and providing guidance on how we can adapt to this new way of thinking and doing. They talk about changes in Mindset, Mechanics and Measures that are needed to support Agile. This describes a general concept rather than a defined methodology. With empowered teams and robust procedures and tools, product quality need not be compromised and we can still retain full traceability and approval, important in regulated industries.<\/p>\n\n\n\n

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Mindset encompasses company culture, values and priorities. It is the starting point for working in an agile way. ISPE talk about Discovery vs. Certainty. Instead of saying ‘we can\u2019t do that<\/em>, our process doesn\u2019t allow that<\/em>, we should ask ourselves \u2018How can we manage this in a way that still meets the customer and regulator\u2019s needs and follows the principles of GAMP\u00ae5?<\/em>\u2019. Creativity and lateral thinking become part of the engineer\u2019s work as much as following the spec.<\/p>\n\n\n\n

To be agile in our project delivery, we need:<\/p>\n\n\n\n