Dissecting Electronic Signatures for the Life Sciences

Electronic signatures (e-signatures) can save substantial time and money. As a result, according to Forrester Research, the use of e-signatures has grown at an average annual rate of 53% since 2012, and more than 700 million documents and transactions are expected to be signed electronically by 2017.

This trend applies to clinical research and other life science activities. For example, a nationally renowned clinical research institute that implemented an e-signature pilot program reduced the time required to obtain signatures on clinical trial documents from a range of 19 to 58 days to only three to four days.

The FDA’s definition of e-signatures is found in 21 CFR Part 11: Electronic Records, Electronic Signatures. These regulations specify FDA’s requirements for using records and signatures in electronic form to meet the agency’s recordkeeping requirements. However, the title of the regulation itself uses the term “electronic signature,” which can be misconstrued. The regulation deals with several different types of signatures in electronic form. The different types of signatures include “standard” electronic signatures, digital signatures, and handwritten signatures captured electronically. Before adopting an esignature technology, it is important to understand the substantial differences between them.

To read more about electronic signatures, non-biometric signatures, digital signatures and electronically captured handwritten signatures, download this free pdf.