Is a zebra black with white stripes or white with black stripes? I think many people ask the same question regarding electronic and digital signatures.
For the past several years I’ve noticed how frequently the terms electronic signature and digital signature are misused and thrown around loosely, which compelled me to introduce some clarity on the subject.
Electronic and digital signatures are not the same thing. In fact, their structure, application, regulation and business scenarios are completely different – sure, they are both a final product of our drive to digitize various business processes, but this is where the similarities end.
In this, the second post in our online signatures series I’ll take a closer look at electronic signatures and some of their real-world business applications.
What is an electronic signature?
Firstly, let’s clarify what is the generally accepted meaning of the term electronic or e-signature. According to the U.S. Federal ESIGN Act passed in 2000, an electronic signature is an "electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record."
In other words, an electronic signature, often referred to as an e-signature, is a person’s electronic expression of his or her agreement to the terms of a particular document.
What are electronic signatures used for?
Unlike graphical signatures, electronic signatures are designed to provide an audit trail of who signed the electronic document, the processes they followed to do it, and their intent to act based on that document. Which is why, unlike digital or graphical signatures, electronic signatures are regulated by ESIGN Act Sec 106 in the United States and numerous other regulatory authorities in other countries.
Typically, electronic signatures are used to support the signing of documents used within the life science production, testing and submission process. We often find clients using them to sign study documentation, project reports, and other documentation included within typical eCTD submissions.
Who uses electronic signatures?
Electronic signatures need to comply with the FDA regulation 21 CFR Part 11 to be considered authentic, therefore most of the companies that deploy electronic signatures are typically organizations regulated or affiliated in one way or another with the life sciences industry.
We work with numerous clients operating within the life sciences sector that use electronic signatures at the heart of their business processes. Our own GCI PowerTools for Electronic Signatures is a powerful extension for OpenText Electronic Signatures designed to enable users to have more control over the signing process. It simplifies the signing process and enables them to assemble and sign multiple documents in compliance with the FDA regulations.
If you were using electronic signatures within your Content Suite environment, I’d love to hear more about your experiences and the business scenario’s you are supporting. Feel free to reach out let’s start a conversation.
You want to learn more about the differences between electronic, digital & graphical signatures? Download our comprehensive guide to Online Signatures whitepaper today!