Home Forums Signatures E-signatures & Document Identifiers – Broken e-signatures

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      Michal Fryza

      I would like to seek the opinions and advice of TMF experts regarding possible solutions to the following situation:

      I have a document signed electronically with a validated e-signature, received from an external source.

      According to our internal requirements, every document in the eTMF should include information about the study, country, and site it belongs to (where applicable).

      This document lacks the required information within its content, which prevents a clear QC of the content and associated metadata.

      In such cases, it is required to either attach a cover page to the document or annotate it and scan it with the added information. Unfortunately, both methods—merging cover letters or adding information by hand and rescanning—break the electronic signature.

      What should be done in this situation? What are your practices and recommendations?

      Thank you in advance for any advice and suggestions.

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