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Compliance In Focus
Posted by John Lehmann on Mon, Aug 26, 2013

Electronic vs. Digital

Just what is the difference between digital vs. electronic signatures and does it matter? TheElectronic vs. Digital terms: digital signature, digitized signature, electronic signature and E -signature are used frequently but do you know what they mean? How do they compare to the handwritten signature?

  • A review of internet searches reveals these definitions can vary with the website viewed. Since research is our focus, we will use the definitions from The Code of Federal Regulations (21 CFR 11.3b):
  • (5) Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.
  • (7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.
  • (8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate; a writing in a permanent form. The act of signing with a writing or marking instrument, such as a pen or stylus, is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

Digital and electronic signatures should be able to be authenticated. Electronic and handwritten signatures should be linked to the respective electronic records to ensure the signatures cannot be copied, or otherwise transferred to falsify another electronic record (21 CFR subpart B 11.70).

Who determines which type of signature is required? Typically, it is determined by regulations or SOPs. A good rule of thumb may be to sign anything that requires review or approval. Which method of signature (digital or electronic) is used is not typically mandated. However, the ability to prove the signature is verifiable, unique to the individual (attributable), can it be proven that the document has not been tampered with, revisions to the document were authorized, and that duplicate documents can be identified as copies of the original should be considered. UETA, the Uniform Electronic Transaction Act, gives legal recognition to electronic signatures (also referred to as E-signatures).

Many of us still use handwritten signatures, or “wet ink” signatures.  A “wet ink” signature is an original signature written on a piece of paper, as opposed to digitized version of a signature (also know as a “dry ink” signature) which can be copied cut and pasted into a document.  Wikipedia defines digitized signature as “an image of a person's handwritten signature that is saved in an electronic file. Most frequently, a digitized signature comes from an electronic signature pad or is scanned from a paper document. Digitized signatures are not considered be secure because they can be copied and pasted into other documents.” Therefore, a digitized signature is different from a digital signature, but are often used in clinical research to replace handwritten signatures.

Is it appropriate for “digitized signatures” to be utilized in research, such as confirmation letters or periodic reports? In these examples, the documentation is reviewed, edited and approved by various entities before finalization and signatures. Are understanding who made the changes and when the signature was applied, important?   Please let us know your thoughts on using digital/electronic/handwritten and finally digitized signatures.

Photo Credit: Wonderlane

Topics: Digital Signature, Electronic Signature, The Code of Federal Regulations


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