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Hi All, this is a question, or more accurately a poll, for the Publishing Vendors, Regulatory Operations groups, and anyone dealing with eCTD submissions of electronically and/or digitally signed documents.
When dealing with signed documents that have been locked to future edits how do you produce review friendly submission documents (bookmark, link, merge, etc). I'm talking specifically about documents to which you do not have a password to remove edit restrictions. Adobe Preflight can flatten many digital signatures but then why sign electronically in the first place, convenience? There is software out there that will remove a password, probably using the same process in the background, but is that ethical? Years ago I would see people print and scan but that's time consuming. So long as the password does not prevent Opening the document it does not violate FDA validation criteria so the documents could always be submitted as is but often there is a need to merge multiple documents, protocols for example.
Anyway, just curious to hear how people are dealing with these challenges as more and more groups are moving to all electronic and/or digital signatures and while CFR Part 11 Compliance is always a focus how the documents will be processed for submission is often not.
Cheers and happy Friday