Hi,
The white paper on electronic signatures is not available in the link below. Where can I find this PDF document? Any help please..
Thanks in advance.
Mir.
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
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:
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