How does Grand Avenue prevent the unintended use of obsolete documents?

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 Grand Avenue has the design features described below to prevent users from accidentally downloading files for superseded and obsolete Document Revisions.

• As is shown below, the default search criteria for documents includes only documents with status “Effective”. Users must go out of their way to see superseded and/or obsolete documents in their search results.

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• In addition to displaying the document status of “Superseded” or “Obsolete”, as applicable, GAS displays red warning messages “This is NOT the currently effective revision” or “This revision is Obsolete” next to the document file.

Example: Superseded Document

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Example: Obsolete Document

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to “Yes”, which prevents users other than the Document Administrator and Coordinators from seeing document files for superseded and obsolete document revisions.

Example: User View of Obsolete Document Revision