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  • 1.  Design controls process

    Posted 12-May-2022 20:23
    Hello RAPS,
    I need your thought. In my quality system i used eQMS. Now i have a separate system for design controls.. and i need to know how to handle design changes and corrective action in the design control software instead of the eQMS software. if anybody  has been in this situation  please advise

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    Bedwuine Senatus
    QA/RA Director
    Springfield NJ
    United States
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  • 2.  RE: Design controls process

    Posted 13-May-2022 09:02
    Bedwuine,

    I have not been in this particular situation before.  However, my thought was to have your design control software handle the design changes, as that should be included in the software, but "refer" the CAPA items to the eQMS software, depending on which software is better suited for the task.  Additionally, there should be some discussion in your quality manual describing the links and connections of the two systems.

    If you are trying to stop using your eQMS and only use the design control software, then it would depend on the modules and functionalities you purchased/licensed, then your questions would be answered by the software provider's technical assistance.

    Good luck.

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    William Coulston PMP, MS, RAC
    Director of Quality & Regulatory Affairs
    San Antonio TX
    United States
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    Original Message


  • 3.  RE: Design controls process

    Posted 14-May-2022 21:46
    William, 
    6 yrs ago we bought an eQMS but it didnt have design controls module capability and at that time the company wasnt doing design controls either. now,  we start an R&D dept, do we bought another system for design control and i am trying to implement this system into our QMS...
    So, would have a separate SOP for design changes or would you rather have the process describe in your design control procedure...

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    Bedwuine Senatus
    QA/RA Director
    Springfield NJ
    United States
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    Original Message


  • 4.  RE: Design controls process

    Posted 13-May-2022 09:16

    Hi Bedwuine –

     

    Could you be a little more specific about the eQMS and separate design control system? 

     

    Thanks –

     

    Rhonda

     

    Rhonda Johnston | Senior Manager Design Quality Assurance
    rhonda.johnston@smith-nephew.com

     

     




    Original Message


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