Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

QMS/DMS for an IT company

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Rotciv, Jan 28, 2020.

  1. Rotciv

    Rotciv New Member

    Joined:
    Jan 28, 2020
    Messages:
    2
    Likes Received:
    0
    Trophy Points:
    1
    Hi everyone,

    I am currently working for a small-ish medical IT company, manufacturing Class II MD. Actually using SharePoint as QMS and DMS, we are growing fast and it seems that SharePoint may not be the perfect QM tool for our Software Engineers.

    The main complaint we have is, it is user dependent for many tasks: version history, approval process, signature... and therefore we are:

    - loosing a lot of time managing the documentation during a project lifetime;
    - making a lot of mistakes with our templates/document/records;
    - using independent tools for CAPAs and customer complaints;
    - risk review, and design and development tasks are on Azure DevOps.

    We are thinking about moving to Green Light Guru. But I wanted to see if there is others Medical QMS/DMS on the market that are HIPAA and FDA compliant.

    Thank you in advance for your answer, Quality lovers!
     
  2. yodon

    yodon Well-Known Member

    Joined:
    Aug 3, 2015
    Messages:
    105
    Likes Received:
    47
    Trophy Points:
    27
    Nothing is compliant out of the box - they can put the controls in to enable compliance but you have to set it up and use it properly. Don't assume that a tool purchase is a silver bullet and all your issues disappear when you install. And many tools require significant overhead to setup and maintain. I've seen SharePoint used as a viable solution for at least much of document control (and I've seen it set up where it is a complete flop).
     
  3. Rotciv

    Rotciv New Member

    Joined:
    Jan 28, 2020
    Messages:
    2
    Likes Received:
    0
    Trophy Points:
    1
    Thank you for your answer yodon.

    Yes, I guess no system is perfect. I was just wondering if you were aware of a QMS/DMS tool that is more efficient than SharePoint for an Agile IT company using Microsoft environment. But you're right, I am also having a look on how to improve SharePoint with our SharePoint Guru.

    Regards
     

Share This Page