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Need to Validate "off the shelf" Statistical Software Packages ?

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by TheWaeller, Feb 17, 2016.

  1. TheWaeller

    TheWaeller Member

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    Hi all,

    a short question:

    Is there a documented need to validate "of the shelf" statistical software packages like Minitab or JMP?
    Is it thinkable or sufficient for - lets say FDA audits - to rely on / to cite the huge numbers of succesful users of these packages? Similar to published biocomp studies in the net?

    Thanks for any hint
    The Waeller
     
  2. Miner

    Miner Moderator Staff Member

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  3. TheWaeller

    TheWaeller Member

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  4. ncwalker

    ncwalker Well-Known Member

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    My $.02 - ALWAYS verify.

    Minitab and JMP are indeed "off the shelf." But they are not prevalent. They are prevalent with US, the quality community, but that's still not a lot of seats out there relative to say, Google Chrome or Microsoft Excel. Which means because it is specified and not prevalent, there are bugs. Some are idiosyncratic "features" that are annoying. Others are straight up wrong math in the background.

    We had an "off the shelf" gage management package that flat out improperly calculated Gage R&R results.

    Always take a known (even a simple) data set, run it through the package, and convince yourself it works. The makers of software definitely do not understand the concepts such as "validation" and "early containment" like we, the makers of actual parts, do. :)
     
  5. Bev D

    Bev D Moderator Staff Member

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    It depends on what your software is doing and where you are in the FDA hierarchy.
    In general the FDA will take a dim view of any 'software' that is not SAS or R. basically because these 2 packages have logging the mathematical validity of any program can be 'easily' audited and verified. GUI based packages such as Minitab and JMP do not have logging. there math is not easily 'seen'. EXCEL is even easier to see the math but for most manufacturers, EXCEL spreadsheets that perform calculations that control quality and compliance must be validated, so JMP and Minitab are in an even worse position than EXCEL. The number of users is irrelevant. The closer you are to have direct human contact that effects safety and wellness the more you will have to validate your software. Of course casual engineering of JMP or Minitab don't have to be validated as long as the final work is in SAS or R. Just my experience
     

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