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Documentation laboratory Quality control

  • linzyelton linzyelton 26 Oct 2020

    Q:Do we have to have a paper master copy? Can the master copy be an electronic but controlled copy

    A: I think it is nice to print out a paper master copy occasionally. It might be easier to archive this. Given that we have multiple SOPs I reckon that it is easier to keep electronic copies for master copies.
    A: when a laboratory has too many SOPs and forms it is easier to maintain an electronic master copy, it is more feasible especially when done in excel.

  • linzyelton linzyelton 26 Oct 2020

    Q: Do we need to change the version of Master list when we add a new SOP to it? which is the best way to manage a master list in cases where different sets of documents have varying review dates

    A: You don’t need to add a version number to your master list, so that you don’t have to change it each time you change the version number for any of the documents. However, you will need to update the master list if you are adding new SOPs/forms etc.

    A: I noted that a question was asked around master lists and having these version controlled. I believe the response given is to update the version of the master list whenever an update is made. If this is the case, I want to add that the standards used for this training (ISO 15189:2015 & GCP in the Laboratory) do not require this. The requirement is to maintain a current master log or list that lists all current authorized versions or editions of documents in the QMS. Versioning of master lists is not sustainable and not required by the laboratory standards.

    A:When documents are reviewed without any changes made, as a site we give them interim version numbers which help us document that we have reviewed the document.

    A: Your master list can be an excel document or a word document (digital and/or printed), as long as it works

    A: When you add or subtract a column with a different title on Master list it means your master list form has changed, I wouldn't change version for capturing different procedure versions, its like you are capturing different records on the same form.

  • zeusfranck07 Zeukeng Francis 26 Oct 2020

    Dear Linzyelton,
    Please when will the certifcate of attendance be issued?
    Thanks.

  • adeyemikayode399 Adeyemi Kayode 29 Oct 2020

    When will the certificate of attendance be ready? Thanks

  • akwayi20 Akwayi Gilles Mpah 4 Nov 2020

    Hello when will the certificate of attendance be issued. I have been waiting. Thanks.

  • Dear Linzyelton,
    Please when will the certificate of attendance be issued?
    Thanks.

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