1. eTMF.owl: Reference to Carelex shall be removed.
2. eTMF.owl: <owl:DatatypeProperty rdf:about="&etmf;Modified_By"> Definition says username of the person. What value does username provides for interoperability. Username of one application may not mean anything
in another if they are not using the same source. Moreover, in my opinion it is a security risk to send usernames until some security protocol is followed. Would suggest use of some other identifier e.g. email address,
3. eTMF.owl: <owl:DatatypeProperty rdf:about="&etmf;Modified"> The date and time a digital resource was changed in ISO 8601 format. We should stick to UTC format only as ISO 8601 defines two ways of handlijng
timezones.
4. eTMF.owl : <owl:DatatypeProperty rdf:about="&etmf;eSign_Status"> An indication of whether a document or Content Item has been digitally signed. We re only captriung digital signature status . What about
electronic signatures. And also we are not capturing essential properties of signatures like date time, signee and reason for signature.
5. eTMF.owl : <owl:DatatypeProperty rdf:about="&etmf;Format"> Value_Set does not covers many other file formats that could be in eTMF.
Prabhat Vatsal | Principal Consultant
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