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Archiving of GLP studies

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  • Michael
    22/02/2017 14:22
    What is the view on what constitutes adequate "authorisation" of a change to proceed for a GxP system? I have always taken this to mean that specified individuals - e.g. System Owner and Quality Assurance must sign (either on paper on via e-signature) to indicate their approval. However, I have just audited a system where their process is to provide verbal authorisation and have it minuted. (The fact that the minutes did not contain a list of attendees was their downfall in the audit.) But, it did make me wonder if this would actually be an acceptable solution? Personally, I was not comfortable with this - it is easy to minute an attendee as being present when they were actually absent, but more difficult to produce an electronic signature...
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