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Is this approach also valid for hybrid systems where the release is paper-based, but the release is recorded in an electronic system?

17/09/2021 | 1361

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The requirement that the relationships of the single documents need to be stated in an unambiguous way in a hybrid system is decisive. If documentation of the release decision is paper- based, Annex 11 is to be applied only with regard to the supporting documents. A mere reproduction of a paper-based release decision in an electronic system implies the application of the requirements of Annex 11 but not the requirement of a further electronic signature.

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