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Eldin Rammell

Kathie nailed it!

The EMA TMF guidance document provide quite comprehensive requirements regarding electronic filing systems used for TMF content and those requirements apply to the primary eTMF and to supporting systems that also hold TMF content.

In any event, if IP-related records are held outside the eTMF, they would be subject to GMP requirements for computerized systems…. which mirror those for GCP since inspectors use a common GxP document for computerized systems.