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Re: [XP] IEEE requirements/FDA compliance and user stories

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  • Steve Berczuk
    ... I have only limited experience with FDA Compliance but my impression was that Compliance means documenting a process and following the process that you
    Message 1 of 9 , Aug 10, 2004
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      On Mon, 09 Aug 2004 18:27:21 -0000, banshee858 <cnett858@...> wrote:
      > I have a question about IEEE requirements for products/software that
      > fall under FDA compliance guidelines and their relation to user
      > stories. Let me start off this discusion with the fact, I HAVE to
      > write an IEEE requirements document for this product I am creating.
      > My boss is asking for it, so there is no way around it.

      I have only limited experience with "FDA Compliance" but my impression
      was that "Compliance" means documenting a process and following the
      process that you document. So the first task is to understand what
      process your boss wants you to follow and figure out if the steps,
      documents, etc are there because of some over-arching compliance
      requirement or because "this is the way that we've done it before." I
      worked on one FDA-related product (related to an application for
      managing clinical trials) and we used many of the XP practices.

      The only problem any of us saw was whether someone would be able to
      document "XP" in the appropriate way before the compliance audit....

      So definitely try to understand how many of the process steps are
      mandated by rules and how many by convention.

      > his does
      > not mean I am not going to use all my cool TDD and Fitnesse tools,
      > but I have some hoops to jump through before I start.

      I'm sure that what you /meant/ to say was "using TDD and Acceptance
      testing" since the "cool tools" are secondary (I+I > P+T and all that)

      Steve Berczuk | steve@... | http://www.berczuk.com
      SCM Patterns: Effective Teamwork, Practical Integration
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