How do files and dossiers differ from each other?
While the term file usually describes the summary of incoming documents in retrospect, dossier management addresses more complex processes.
A dossier has a structure. There are mandatory and optional documents that must or can be present in the dossier. The order in which the documents are to be presented in the dossier can also be important. A dossier is usually structured in defined sections. A classic application is the approval dossier for drugs. There is the standardised eCTD format.
[GMP Compliance Adviser, Chapter 15.G.3]
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