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Has anyone applied the agile approach to validated systems in the pharma industry? What is the best practice?

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Larry Ng IT Project Manager| N/A Thornhill, Ontario, Canada
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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Eric Simms Senior Program Manager Baltimore, Maryland, United States
This article might provide some useful suggestions you can apply:
http://renttesters.com/2013/04/29/agile-iq-oq-pq/
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1 reply by Lin-en Wu
Apr 26, 2024 12:32 PM
Lin-en Wu
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Hi Eric, I would love to read the article you just shared, but the link is broken, do you have more where that came from please?
Many thanks!
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Sergio Luis Conte Helping to create solutions for everyone| Worldwide based Organizations Buenos Aires, Argentina
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.
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Larry Ng IT Project Manager| N/A Thornhill, Ontario, Canada
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.
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Wade Harshman Scrum Master| GDIT Indianapolis, In, United States
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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Lin-en Wu PM II| Astellas Amsterdam, North Holland, Netherlands
Apr 02, 2017 8:08 AM
Replying to Eric Simms
...
This article might provide some useful suggestions you can apply:
http://renttesters.com/2013/04/29/agile-iq-oq-pq/
Hi Eric, I would love to read the article you just shared, but the link is broken, do you have more where that came from please?
Many thanks!
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Lin-en Wu PM II| Astellas Amsterdam, North Holland, Netherlands
Hi Larry, did you try to use Agile with IQ, OQ and PQ? I would love to hear how that went please!

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