Original written signatures vs. Copies/scans/faxes/electronic documents

[MIREGMGR]

This reminds me of the experience of someone I know who, while serving in the military, had to review certain documents and initial them as evidence of review. One day a document he had reviewed came back to him with a note attached: "This document was forwarded in error and should not have been reviewed. Please erase your initials and initial your erasure."

Perhaps he should have responded, "Your request is not consistent with proper document procedure, which calls for lineout rather than erasure. Please line out your previous request for erasure of initials, initial your lineout, and re-state your request to call for lineout of initials."

 

[jkuil]

Since this earlier discussion, we have been told verbally by FDA that their current stance is exactly what KathyKru said above in her 15th May 2009, 10:08 AM post, i.e. a scan or other image of a document carrying an original physical signature is acceptable only if a separate process at the time of scanning or imaging has verified that the scan or image is a true copy, and that separate process has been attested with the signature of the responsible individual.

I hope they will put it in writing as well, as this seems a logical approach. Generally, I always provide this advice to my customers, with a concern for the FDA's position. I would love to lift this concern.

 

[Juan Dude]

Based on these guidelines by the FDA, medical device companies should not shred their originals. http://web.archive.org/web/20080223195921/http://www.fda.gov/cdrh/elecsub.html

Link is dead, what did the original link reference to?

 

[howste]

Link is dead, what did the original link reference to?

I've replaced the dead links with links to an archived page in the Internet Archive.

 

[Caster]

Perhaps he should have responded, "Your request is not consistent with proper document procedure, which calls for lineout rather than erasure. Please line out your previous request for erasure of initials, initial your lineout, and re-state your request to call for lineout of initials."

This made my day!