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SAP compliance with 21 CFR Part 11.

Apr 12, 2017 at 03:58 PM

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Hi,

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

http://www.sap.com/bin/sapcom/en_us/downloadasset.2013-12-dec-20-17.complying-with-global-eres-regulations-in-the-life-sciences-industry-pdf.bypassReg.html

Thanks in advance.

Mir.

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2 Answers

Dipeshkumar Bhavsar Apr 13, 2017 at 03:30 AM
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Craig S
Apr 20, 2017 at 03:08 PM
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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

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