[OASIS Issue Tracker] (ETMF-15) References to EDMS are unclear

[OASIS Issues Tracker <workgroup_mailer@lists.oasis-open.org>]

Jennifer Alpert Palchak created ETMF-15:
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             Summary: References to EDMS are unclear
                 Key: ETMF-15
                 URL: https://issues.oasis-open.org/browse/ETMF-15
             Project: OASIS Electronic Trial Master File (eTMF) Standard TC
          Issue Type: Task
          Components: Specification
    Affects Versions: CSD-PR-1 Comments
         Environment: Eldin Rammell <eldin.rammell@rammell.com>
            Reporter: Jennifer Alpert Palchak
             Fix For: CSD-PR-1 Comments


The use of the word “automated” in paragraph 2 of 2.1 is not understood. Please explain what an “automated EDMS” is and how this differs from an “EDMS”  or remove the word “automated”.
The sentence “For those without access to EDMSs, a method to exchange, view, and navigate content offline is needed” is not understood. The use of an EDMS is unrelated to being online or offline. The issue is simply one of being able to exchange, view and navigate content on electronic repositories containing clinical trial master file content, irrespective of whether those repositories are enterprise systems, EDMSs, Microsoft Access databases or whatever.




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