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57940RE: [SCRUMDEVELOPMENT] Scrum in regulated environemnt

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  • Mark Graybill
    Aug 18, 2014

      Forgot to mention, the one thing that annoys me about waterfall vs. Agile is that Agile iterates natural stages stipulated in waterfall – even if one of the stages (requirement-to-design-to-code for instance) lies entirely in the mind of the programmer for the moment before code is written.


      However, some features of modern day pacemakers (AKA pulse generators) can be too complex for mere text (use stories) and modeling the feature beforehand may be beneficial in the process of conceptualizing the feature’s requirement.  But that is usually the research team – the experts in the domain.


      FDA regulation does not prescribe waterfall or proscribe Agile.  The gist of FDA regulation is that your process has certain components and that you can prove you follow it (objective evidence).


      For instance, if you’re using Xp and your process requires design diagrams as objective evidence for design, use a software tool to create them from code.  This is acceptable if your process incorporates it in a way that satisfies FDA regulatory requirements.


      From: SCRUMDEVELOPMENT@yahoogroups.com [mailto:SCRUMDEVELOPMENT@yahoogroups.com]
      Sent: Saturday, August 16, 2014 9:24 AM
      To: SCRUMDEVELOPMENT@yahoogroups.com
      Subject: Re: [SCRUMDEVELOPMENT] Scrum in regulated environemnt



      Medtronics builds things like pacemakers and they’ve been doing Scrum/Xp/Agile for years.


      On Aug 15, 2014, at 3:48 PM, Mahmud Mamun mnmamun@... [SCRUMDEVELOPMENT] <SCRUMDEVELOPMENT@yahoogroups.com> wrote:

      Anyone has any real life experience to implement Scrum in regulated environment, to be specific in life science domain? I'm struggling to understand how we can adopt agile values where the process has to comply with FDA regulations that seemingly coming from waterfall concept?


      Ron Jeffries

      I know we always like to say it'll be easier to do it now than it

      will be to do it later. Not likely. I plan to be smarter later than

      I am now, so I think it'll be just as easy later, maybe even easier.

      Why pay now when we can pay later?


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