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Topics: Agile, IT Project Management, Pharmaceutical
Has anyone applied the agile approach to validated systems in the pharma industry? What is the best practice?

I am interested to know how one may fit the system validation activities (SOP, IQ,OQ,PQ, etc.) in an agile framework. What may be some of the challenges and how they can be overcome. Thank you!
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This article might provide some useful suggestions you can apply:

I did. But first of all please understand that Agile is not a method or process. You can apply Agile to any method or process including some with highly regulations like validation in the pharma industry.

Thank you Eric for sharing the relevant post! We're looking at a dedicated sprint prior to release to formalize requirements, IQ, OQ & PQ. Glad to learn that others had tried that approach. I would like to find out what challenges people faced and mitigation strategies.

Thank you Sergio for your clarification on the agile definition. Are there any case studies/lessons learned that you could share? Any tips & best practices on this topic will be much appreciated.

Agile is perfect if you're involved with the R&D side.

The biggest challenge you'll face is your own organization. Agile is a culture, and the Agile values and principles are prerequisites to any Agile framework (i.e. Scrum) that you intent to use.

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