Hi,

try below link.

https://archive.sap.com/documents/docs/DOC-7854

https://archive.sap.com/documents/docs/DOC-1914

http://www.sdlc-bs.com.mx/files/literatura/SAP_FDA_title21.pdf

http://docplayer.net/18526360-Complying-with-global-eres-regulations-in-the-life-sciences-industry.html

Regards,

Dipeshkumar Bhsavr

Here's the actual CFR info from the FDA (current from April 2016):

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

This is the section on electronic signatures:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1&subpartNode=21:1.0.1.1.8.3

This is the guidance PDF paper for electronic records and signatures from the FDA. But it is quite old, (2003)

https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125125.pdf

There are a ton of web sites, blogs and papers on the net that cover this info. Please search.

Craig