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Validation of MiniTab for medical industry?

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Viewing 7 posts - 1 through 7 (of 7 total)
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  • #53748

    Örtlund
    Participant

    Perhaps a odd question. Yesterday I was doing some introduction training for MTB within the company and I got a question if MTB were validated.

    From what I did understand from the question there are some demands relating to export and import data so that the data not are distorted.

    The question popped copy and pasting graphs, but if I did understand the question correct it does apply to data transferred from one program to another.

    Anyone knowing anything about this?

    Regards

    /peteR

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    #191309

    Robert Butler
    Participant

    Validation of code usually takes two forms:

    1. If I write code where all I’m using is existing methods that a part of a computer package and all I’m generating is output from those package components someone else has to look at the code and agree that the approach is the correct one.

    2. If I’m writing code where I actually have to create something new – say write a subroutine that does some kind of test not a part of the current package then to validate that someone else has to independently write code using the same package, run the same data and arrive at the same answer.

    As for data – the focus is on issues of changes to the data. Most of this has to do with tools used to create, import, and export data. For example, Excel would not be an acceptable format for a validated data set because it is far too easy to make irreversible mistakes in data set construction and manipulation (e.g. thinking you were sorting the entire page when you actually sorted a single column).

    Where I work data and code validation are a requirement on many projects. As a result we never use interactive anything in our work. Everything is written in code so programs like SAS, R, and Splus are the packages used in our analysis.

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    #191310

    Klerx
    Participant

    Ask Minitab, we have worked together with them on that.
    René

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    #191311

    Örtlund
    Participant

    Thanks for the answers and inputs! =)

    I will contact MTB on this topic if comes to that point, good to know that it has been done.
    And also as Robert points out, it’s mostly how the data is imported and exported.

    The question popped when we talked about inserting graphs in reports, is it ok to use copy/paste from MTB in to a report? (Risk of distorting the picture elements due to format) and from that to import and export data.

    Dose anyone know if there are any regulatory demands from government on this issue?

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    #191315

    HopeOverExperience
    Participant

    As far as I understand it.

    It will depend on what regulations you are working to but in most cases yes. If you are working to any of the GXP regulations these do have regulations on how you validate software and how you document the processes.

    The aim of these validations is to make sure that the software does what you want to do and doesn’t sometimes do something different.

    The validation isn’t that hard though, you just need to document the process by which you want to use the software, create a test plan to test that it does what you want it to and then test it.

    What you need to do is make sure you have the procedures written up as you want people to use it as any variation form the procedure will not be validated.

    The rules though vary by compnay and how they’ve interpreted the guidlines or which country you are in a quick talk to you IT or QA department will fill in the details

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    #191316

    Lugo
    Participant

    I am a Black Belt suing Minitab in the medical device and pharmaceutical industry.

    If you are copiing and pasting data or graphs from Minitab or other statistical software in your analisys, the document should have the minitab project file attached or delivered during the delivery of the document you are preparing.

    Although Minitab in this industry is used mainly for reference and for a decision on which path to take, once you take that path, you have to validate the path you used, not the software used to find that path.

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    #191317

    Lugo
    Participant

    sorry I misspelled suing = using

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