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Use of Sharepoint for controlling documents

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by JCIC49, Nov 27, 2015.

  1. JCIC49

    JCIC49 Member

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    I can remember that there were threads about this on the Cove, but I cannot remember the details.

    I am interested in peoples thoughts on this and any issues that have been encountered, especially around traceability, security and validation.

    Thanks for your input

    Jon
     
  2. Qualmx

    Qualmx Well-Known Member

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    Yes,It is possible to perform with Sharepoint such activities.
    But you have to consider the cost
    Server,share point license,client licenses, training and consultancy,because is not to easy for the setup.
    Additionally,there are on the market software specially for the management of documents.
    Hope this help.
    PD
    Pancho user (in elsmar),once suggested to use wiki,maybe pancho, if available, may participate on this thread.
     
    Pancho likes this.
  3. Pancho

    Pancho Active Member

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    Hi Jcic49 and Qualmx,

    Sharepoint provides great traceability and security, and even workflows for validation. It does this using traditional document files, mostly "office" files. If you already have lots such docs, Sharepoint may be a good way to share them.

    But there are a couple of significant downsides to traditional office documents when compared to documents in the form of wiki pages: file-documents discourage contextual linking and continuous improvement. Wikis encourage both.

    Contextual linking is key to making documentation truly available at points through "small world network" effect. Continuous improvement of documents happens when you save every edit with accountability. Wikis do these things automatically and very well. Geometrica implemented its QMS using a wiki in 2008, and we continue improving with it to this day.
     
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  4. JCIC49

    JCIC49 Member

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    Thanks for the feedback

    With regards to the cost of set up etc. This is not an issue as the company is already using it for other activities, but this is why it is difficult to justify a standalone system, when IT are saying that share point will do everything I need.

    This is why I am looking for information on the positives and negatives, before it is taken down a route that causes issues.

    The plan at the moment is to implement it in small steps validating each process as we go, and ensuring that it is robust.

    Jon
     
  5. Matt Guilbert

    Matt Guilbert New Member

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    We currently use SharePoint 2010 for this.

    Pros:
    1. Can limit users access and ability to edit documents. (read only, edit, etc)
    2. If set up properly you can store old revisions of a document as inactive, therefore you can go back to them if you need to.
    3. Can easily export list of documents to excel file to use in document audits
    4. You can search for documents using key words
    5. You can set e-mail, text, rss feeds for users to notify them when a document changes.

    Cons:
    1. If you use search for a document, you may receive inactive documents. There are ways to limit this however.
    2. You need to have a gatekeeper who uploads and inactivates documents. Unless you want multiple users to be able to do this.

    We have also used SharePoint Lists for issuing, responding to, and closing non-conformances.

    The process works as follows the person who identifies the non-conformance enters it into the SharePoint list.
    The department head receives an automatic e-mail with a link to the non-conformances
    The department has a set amount of time to respond with a root cause, corrective action, and effective date.
    During the next audit or when the person who identified the non-conformance is satisfied with results the non-conformance is closed.
     
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  6. JCIC49

    JCIC49 Member

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    Matt

    Thanks for the feedback.

    Jon
     
  7. Claes Gefvenberg

    Claes Gefvenberg Moderator Staff Member

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    We use a Sharepoint based application too, but it also goes through a loop churning out a pdf copy of the finished document before it is published.
    Yep. Our inactive documents are moved out of harms way.
    Exactly: We do want multiple users to be able to work with their documents, but I and one more person need to say ok before documents are published.
     
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