Re: E-Signatures

[Harrold Ahole <madman () MYEASTSIDE COM>]

Faith Mcgrath wrote:
> I am also interested in what people are using for electronic
> signatures if they need to certify that they are in compliance with
> FDA Electronic Records; Electronic Signatures regs -- 21 CFR Part 11
> (http://www.fda.gov/ora/compliance_ref/part11/). I am just being to do
> some background reading on the requirements, but we are beginning to
> see this requirement related to pharmaceutical research protocols.
> Thanks. -fm
21 CFR Part 11 is something entirely different and is more involved
(harder to implement).  Certainly if you are doing FDA work with pharma,
you'll need to investigate this.

But nothing like that is required for basic contracts where only US
Esign Act comes into play and is far easier to comply with, allowing you
to balance risks with how much certainty user authentication is valid.
For example, if a student were to turn in a paper or fax a document to
you, you'd likely have no way to authenticate the student's handwritten
signature (rarely is a notary involved, and handwriting expertise is
even rarer with signature cards to compare with pretty rare), yet such
signed paper documents are accepted all the time.  If you compare
handwritten signatures with student IDs, then you'd want something
similar online in which the student authenticates first.

Harry