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QMS Document Management System

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Zareh Tashjian, May 14, 2021.

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  1. Zareh Tashjian

    Zareh Tashjian New Member

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    Hi Everyone,

    I have built a QMS for our organization using MS Teams and SharePoint.

    However, I feel that there may be better tools and 3rd parts software in terms of:

    Audit Management
    Compliance Management
    Corrective and Preventive Actions (CAPA)
    Defect Tracking
    Document Coding & Control
    Internal Departments and Cross Functional (Supplier) Quality Control
    Training Management

    I am at the moment looking at various 3rd party tools but would like to see if anyone can recommend a trusted and good option.

    SharePoint via MS Teams is ok but needs a lot of customization and is not very easy to use for QMS, would really appreciate any suggestions

    Thank you
     
    Zareh Tashjian, May 14, 2021
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I have had a similar search and been unsuccessful so far...
     
    Andy Nichols, May 14, 2021
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  3. qmr1976

    qmr1976 Well-Known Member

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    At my previous job in a similar role, they used MasterControl. We were able to customize it based on different modules we needed. (CAPAs, Change Control, Training, etc.) I believe they are based out of Utah and their customer support was decent. The downside to it was, we had to perform IQs, OQs and PQs (Installation, Operational and Performance Qualifications) to validate the software.
     
    qmr1976, May 14, 2021
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  4. Zareh Tashjian

    Zareh Tashjian New Member

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    Zareh Tashjian, May 19, 2021
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    qmr1976 likes this.
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'll be interested to know your results. Looking at the screen shots and their descriptions of sections of the standard (ISO9001) tell me they fall into the same trap as every other software - it's worsen by people who have little/no experience of QMS implementations.
     
    Andy Nichols, May 19, 2021
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  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    MasterControl looks like a lot of well developed modules. They try to tempt us with a lot of name dropping, biggish (no doubt happy) clients and so on.

    MomentumSystems didn't have much to show me for document control, calibration or risk management. But one thing I have noticed over the years is organizations getting immersed in proprietary software that is created, sold, and managed by a company that eventually itself gets sold or whatever - then the organization must figure out what to do with all of those processes no longer having apps, and reams of data that do not transfer to other platforms. Lotus Notes comes to mind.

    It is my hope that this would not happen with the open source MomentumSystems. It is my further hope that the modules are not terribly complex (I have worked with some pretty scary document control software) and that the organization would be able to customize the modules; I see the usual approaches to risk management, not the range of creative approaches we have available to us.
     
    Jennifer Kirley, May 20, 2021
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  7. DemarcusPreston

    DemarcusPreston New Member

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    For anyone exploring alternatives to SharePoint and MS Teams for QMS, it might be worth considering a solution that integrates multiple aspects of document and compliance management.
     
    DemarcusPreston, Jul 25, 2024
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    One aspect I’ve found which plagues all software “solutions” is the poor understanding of internal audits and their management. They all default to a time-based schedule and directly link to the corrective action function - either with or without non-conformance management. Both of these glowing issues show they confuse external audits with the needs of internal audits.
     
    Andy Nichols, Jul 25, 2024
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  9. andic

    andic Member

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    My previous company used Qpulse which I thought was very good. Especially for document control and linking things together. And also reporting out statistics.

    looked into getting it for my current employer few years ago and it is very expensive.
     
    andic, Jul 25, 2024
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    These are good points. Those of us who have worked in software development know these are “core competencies” associated with software development hence, QMS software usually do them well, because it’s “baked in”. Other aspects, such as internal audits, calibration etc not so much.
     
    Andy Nichols, Jul 25, 2024
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  11. andic

    andic Member

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    I have always found that the first requirement for achieving a good IT based ERP/MES/QMS/LIMS etc is that the system it’s replacing was well thought out and working. I have never seen software provide a silver bullet for a delinquent system.
    That is probably because as you say, the writers of off the shelf systems don’t quite know what the customer needs, and in the delinquent cases nor do the customer.
    The NHS is probably the primary example of this (and the pushing of a solution no one asked for)
     
    andic, Jul 26, 2024
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    Andy Nichols and Bev D like this.
  12. Devesh#89

    Devesh#89 Member

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    Hi andy, i saw your post regarding IQ OQ and PQ for the software and found it very fascinating could you help me to know more about it as we are going to make in house software for HRMS so how could i proceed for validation and how could i done it successfuly
     
    Devesh#89, Aug 2, 2024
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  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The post you referenced isn't mine! Sorry!
     
    Andy Nichols, Aug 2, 2024
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  14. Devesh#89

    Devesh#89 Member

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    OOH apologies Andy,

    Is there anyone who can help?
     
    Devesh#89, Aug 5, 2024
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  15. DemarcusPreston

    DemarcusPreston New Member

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    One option that stands out is document management. It provides a comprehensive suite of tools for audit management, CAPA, document control, and more. This could simplify your processes and reduce the need for extensive customization.
     
    Last edited by a moderator: Aug 15, 2024
    DemarcusPreston, Aug 15, 2024
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  16. Miner

    Miner Moderator Staff Member

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    It was @qmr1976 's post. He hasn't visited since July.
     
    Miner, Aug 15, 2024
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