[Leon Kuik]

Hi Sylwia, this is an ongoing discussion in my organization, too.

Some tough nuts to crack – like the question if the redacted documents need to be in the TMF, or not.
But also questions if available non-eTMF solutions that can do a better job on submission dossier management should be considered as the repository for these documents (with a reference to that system in the eTMF).
Looking forward to hear thoughts and ideas from others.

[Author]

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