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  • 1.  Design controls software

    Posted 17-Feb-2022 09:36
    Hello,
    Any recommendation for a design control software/ platform.Thanks

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    Bedwuine Senatus
    QA/RA Director
    United States
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  • 2.  RE: Design controls software

    Posted 17-Feb-2022 09:39
    The software will be for medical device.. forgot to mention

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    Bedwuine Senatus
    Springfield NJ
    United States
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    Original Message


  • 3.  RE: Design controls software

    Posted 18-Feb-2022 11:45
    Hi,
    There are many tools to choose from, and they all come with pros and cons. To me, the challenge is that every organization comes with their preferences which can make the same tool perfect in one context but painful to use in another context.

    Perhaps I'm knocking on open doors, but my recommendation would be to invest the time in identifying what support you expect to get from a tool before looking at tools.

    For example, if you know you have to deal with frequent releases of your product, I would look into how a tool can support building a DMR or Technical file.
    Furthermore, if you work with software, you probably already have tools supporting design control for the software development work. Do you want the tools to co-exist (how?) or replace what you already have?

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    Christian Kaestner
    Sweden
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    Original Message


  • 4.  RE: Design controls software

    Posted 18-Feb-2022 13:19
    For the purchase of software systems always start with your documented requirements.  What do you want the software to do? What do you not want it to do?  Do this in as much detail as you can.  NEVER buy software systems until you have done this.

    Next you get a demo package of the software you choose so you can use with your data for a bit, to see if it works the way you expect.  If you have several competing packages run them all.  Today you need to look in depth at cyber and data security of the software packages you choose, and the revision and update processes.  How often are they updated?  And when are security updates done?

    Then compare the packages to see which best meets your needs.  

    I was taught this  many years ago by the IT department in the company I was working for at the time and went thru a number of projects with them before I left the company.  This process always worked well.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
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    Original Message


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