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Subject: Public review comments for etmf-v1.0-csprd01: 5.1.1.2 Classification Categories Naming Scheme


Comment type [technical]

Impact [major]

As previously stated, a taxonomy with standardized category naming is not essential for eTMF interoperability and content exchange. It provides unnecessary complexity and limits the flexibility for eTMF solution developers/vendors. Interoperability only requires a standardized and unique content classification code or ID.

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.



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