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Minitab Software Validation?

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Viewing 8 posts - 1 through 8 (of 8 total)
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  • October 16, 2006 at 1:48 pm #44911

    Bulldog
    ★ 10 Years ★
    Participant

    Am currently working for a medical device company, and the question has risen has minitab ever had software validation carried out and if so, how do i prove it?

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    October 18, 2006 at 1:05 pm #145052

    Bulldog
    ★ 10 Years ★
    Participant

    no one have any ideas?

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    October 18, 2006 at 1:36 pm #145054

    Rodrigo
    ★ 10 Years ★
    Member

    hi bulldog,
    i have contacted minitab to know exactly what you are trying to find out. In a heavy regulated industry you must have your software validated. If you want to know the details of mintabs reply email me to [email protected]
    speak to you soon

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    October 18, 2006 at 3:00 pm #145059

    Elaine
    ★ 20 Years ★
    Participant

    Rodrigo;
    Could you also send me the information on Minitab?  I am also in the Medical Device Industry and am in need of this same information.
    My e-mail is [email protected].
    Your anticipated response is greatly appreciated.
    Thanks!!

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    October 18, 2006 at 3:21 pm #145061

    Ozarski
    ★ 10 Years ★
    Participant

    We have had many companies in pharmaceutical and medical device manufacturing validate their software.  Please call your sales representative for help.  Additionally, the procedures that we use internally to validate our software can be downloaded from: http://www.minitab.com/support/docs/softwarevalidation/default.aspx
    Let me know if you have any questions.
    Jeff O
    Minitab Inc.

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    October 18, 2006 at 4:12 pm #145064

    Elaine
    ★ 20 Years ★
    Participant

    Jeff;
    Thanks so much for the link.
    When we attempt to calculate Cpk by hand, using AIAG Methodology, we can not get correlation with Minitab results.
    How does Minitab calculate Cpk?  Is it based on a mean sigma shift?
    We have attempted to contact Minitab; however, we were told that the formulas used in their calcualtions are proprietary.
    Thanks in advance for your help!!

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    December 13, 2006 at 12:48 am #148879

    Daniel G
    ★ 10 Years ★
    Participant

    Hi Elaine,Below is a link to Minitab’s Answers Knowledgebase that should show
    you how cpk is calculated in Minitab.http://www.minitab.com/support/answers/answer.aspx?id=294Daniel

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    December 13, 2006 at 2:57 pm #148905

    Daniel G
    ★ 10 Years ★
    Participant

    You can find the calculations that Minitab uses for Cpk, by going to the link below.
    http://www.minitab.com/support/answers/answer.aspx?id=294
    Daniel G

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