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    I recently started working on a fairly new test team for a software that is 11 CFR part 11 regulated. We would like to be more agile in our approach to developing the software but are struggling to determine where the validation (plan and report) fit into agile iterations. Is anyone currently using agile development for regulated software and can provide suggestions on what that looks like from the testing side?


    What do you mean by “regualted”? The validation, standards valid for some industry?


    Our software needs to be US FDA 21 CFR part 11 compliant and as such must be validated prior to implementation (see http://www.ofnisystems.com/services/validation/software-validation/ for a more detailed explanation if you aren’t familiar with the process). The validation process is documentation heavy which goes against the spirit of the agile manifesto (working software over comprehensive documentation).
    We are exploring ways to deliver software more efficiently and agile methodologies are being discussed. The problem we run into is where does validation fit? Do we do mini validations with each sprint? Do we have a hardening sprint that is solely for validation? We’d love to hear any suggestions from organizations that are maintaining compliance standards when using agile development methodologies.


    Hi Jenny,

    Here are some links for you. I’m certain there’s info out there – this is not new…

    • Guidance on the use of AGILE practices in the development of medical device software https://my.aami.org/aamiresources/previewfiles/TIR45_1208_PREVIEW.PDF
    • Agile in an FDA Regulated Environment: https://www.slideshare.net/pathf/e-book-agileinanfdaenvironment
    • Agile Adoption in Regulated Environments:  https://www.scrumalliance.org/community/articles/2015/march/agile-adoption-in-regulated-environments
    • Agile Development in Highly Regulated Environments: http://www.agileconference.org/wp-content/uploads/2012/10/Agile-in-Highly-Reg-Env-v0-5.pdf

    Thanks very much for the information, Jesper! This looks like a good place to start.

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