Every day, individuals are more and more likely to sign documents electronically. But, just what is an electronic signature? Are there different types of signatures? And, what type of signature is needed in different situations? We will cover the above, and more, as we delve into the technology behind signing documents electronically.
Electronic signatures vs. Digital signatures
An electronic signature is used to verify a document. To create an electronic signature, you can do it by typing in your name on a form or scan a copy of your signature and using the image to sign a document. As you can probably tell, you cannot validate these types of signatures through electronic means and therefore they are hard to audit and can be legally repudiated. You cannot trace an electronic signature to a specific individual or validation process. Electronic signatures can also be vulnerable to tampering. On the other hand, the benefit to electronic signatures is that they are an easy way to get people to sign documents quickly online.
Digital signatures are a type of electronic signature, however, they are much more secure and auditable. A digital signature has an identity-based certificate (usually a PKI, or Public Key Infrastructure based digital certificate) that is unique to an individual and is saved on their browser or on hardware. This means it has a unique “fingerprint” that is auditable. It can be validated each time a person digitally signs a document. A digital signature is permanently embedded into the document being signed and is used to secure a document from further changes. Once the document is signed, if attempts are made to change the document, then the signature is invalidated. Lastly, a person who has used a digital signature cannot refuse having signed a signature if that signature has a valid certificate.
Why use a digital signature?
Digital signature technology allows businesses and industries to conduct business efficiently and securely. In health sciences and clinical trials, there are regulatory requirements that require the signatures used to sign forms, documents, etc. are trusted, unique, and that the information contained in the document is not changed after signing. This helps to prevent forgery as well.
SureEsign has a very easy to use interface – just select the people you need to sign, select the document, and open the workflow to get started. The order in which you need the document to be signed (1st signer, 2nd signer, etc) and signing level required (Basic Trust, High Trust) can be defined.
SureClinical launched its SureEsign product to meet the trusted digital signing requirements for health sciences and specifically clinical trials. SureEsign with Adobe Certificates on Google Cloud meets the FDA Part 11, EU Annex 11, HIPAA compliance and NIST FIPS-14-2 level 3 US Federal security standards. It works well for clinical trials especially with clinical trials teams – including sites, partners, suppliers, CROs, and sponsors – being distributed in many different remote locations. SureEsign is a featured part of our Eclinical Ecosystem that can be deployed quickly for new clinical trial studies or entire biopharma companies. Some of its features include multiple bulk recipients signing (for example, send one document to 50 investigators and get 50 individually signed documents returned), web-fillable forms, enterprise connectors for G Suite and Microsoft 365 applications via a REST API.
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