Glossary Item






Electronic Signatures

 

In generic terms, an electronic signature is some form of uniquely identifying the signatory of a document that is stored electronically. There are a number of software packages that allow this in a generic sense. Some use passwords, others use graphics pads that one physically signs using a stylus – this is widely used in retail.

Conceptually, if a document (or any data) is signed digitally, it is a valid as if it was signed physically. Therefore, the electronic signature must be more than just a system administrator assigned password, since someone else knows it.

There is also a growing availability of biometrics - the use of various biological unique identifiers other than passwords and signatures. These include hand scanners (as used by the US Immigration Service), to fingerprint scanners or retinal scanners (as used by Canada and US Customs NEXUS service). These devices convert the digital information into a mathematical algorithm which becomes the unique password.

In financial services there are specific controls for on line banking and ATMs.

In the context of food, pharmaceuticals, and cosmetics, the FDA has very specific regulations regarding electronic signatures as defined in 21 CFR Part 11. The regulations are available, but in general terms the password has to be controlled by the user, encrypted so no one else cold find it out without having been told by the user, and has rules that are enforced around expiry and reuse.

WEBSITE:
      * http://www.fda.gov/ora/compliance_ref/part11/FRs/background/esigrpt1.pdf



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This page last updated: 08/30/2011