According to ISO 13485:2016 clause 4.2.4(h), a document control system must “prevent the unintended use of obsolete documents and apply suitable identification to them.” Grand Avenue has the design features described below to prevent users from accidentally downloading files for superseded and obsolete Document Revisions.
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In addition to displaying the document status of “Superseded” or “Obsolete”, as applicable, GAS displays red warning messages “This is NOT the currently effective revision” or “This revision is Obsolete” next to the document file.
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Example: Obsolete Document
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Finally, if an organization feels that more explicit controls are necessary, they can set the following Document Control process option to “Yes”, which prevents users other than the Document Administrator and Coordinators from seeing document files for superseded and obsolete document revisions.
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Example: User View of Obsolete Document Revision
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