10 Questions: FDA Compliance Using Electronic Signatures — Part 1

By Rodd Schlerf, FDA Markets Manager, ARX

1. What are the differences between electronic and digital signatures?

Digital signatures are a subset of electronic signatures. Digital signatures is the term that we use to describe standard electronic signatures. In the United States, the digital signature standards are published and maintained at the federal government level by the National Institute of Standards and Technology (NIST).

These same standards are adopted by other countries, industries, independent standard bodies, and independent software vendors around the world. Independent software vendors supporting digital signatures in their software applications include Microsoft, Adobe, Oracle, OpenText, EMD, Laserfiche, Alfresco, and any portable document format (PDF) vendor that adheres to the ISO PDF standard. In other words, the most popular document authoring tools and document management systems can “plug and play” with any supplier’s digital signature product.