Both the United States Electronic Signatures in Global and National Commerce (ESIGN) Act, and the Uniform Electronic Transactions Act (UETA), have four major requirements for an electronic signature to be recognised as valid under U.S. law. Those requirements are:

  • Intent to sign – Electronic signatures, like traditional wet ink signatures, are valid only if each party intended to sign.
  • Consent to do business electronically – The parties to the transaction must consent to do business electronically. Establishing that a business consented can be done by analysing the circumstances of the interaction, but consumers require special considerations. Electronic records may be used in transactions with consumers only when the consumer has:
    • Received UETA Consumer Consent Disclosures
    • Affirmatively agreed to use electronic records for the transaction
    • Has not withdrawn such consent
  • Association of signature with the record – In order to qualify as an electronic signature under the ESIGN Act and UETA, the system used to capture the transaction must keep an associated record that reflects the process by which the signature was created, or generate a textual or graphic statement (which is added to the signed record) proving that it was executed with an electronic signature.
  • Record retention – U.S. laws on eSignatures and electronic transactions require that electronic signature records be capable of retention and accurate reproduction for reference by all parties or persons entitled to retain the contract or record.

DocuSign’s solutions exceed these requirements and are warranted for compliance with the ESIGN Act.

US life sciences regulations (21 CFR Part II)

Depending on your use case or industry, federal and state regulations may impose additional requirements beyond those of the general U.S. laws regarding eSignatures and digital transactions. For example, 21 CFR Part 11 (“Part 11”) spells out requirements for electronic records and electronic signatures to be accepted by the FDA. Among other things, Part 11 requires that electronic records:

  • Be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern valid or altered records
  • Be able to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the FDA
  • Ensure records are protected
  • Limit access to authorised individuals
  • Use secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records

The DocuSign product that works best for you can help you meet industry regulations. Learn more about DocuSign and 21 CFR Part 11.

History of electronic signature law in the United States

The ESIGN Act is a federal law passed in 2000. It grants legal recognition to electronic signatures and records if all parties to a contract choose to use electronic documents and to sign them electronically.

UETA, a precursor to the ESIGN Act, was introduced in 1999 and has been adopted by 47 U.S. states, as well as the District of Columbia and the U.S. Virgin Islands. Among other things, UETA provides that when a law requires either a writing or a signature, an electronic record or an electronic signature can satisfy that requirement when the parties to the transaction have agreed to proceed electronically.

UETA and the ESIGN Act solidified the legal landscape for use of electronic records and electronic signatures in commerce by confirming that electronic records and signatures carry the same weight and have the same legal effect as traditional paper documents and wet ink signatures.* Both laws provide the following:

  • No contract, signature, or record shall be denied legal effect solely because it is in electronic form
  • A contract relating to a transaction cannot be denied legal effect solely because an electronic signature or record was used in its formation

*The law for electronic signatures in most countries spells out certain types of documents or document categories for which electronic signatures are not appropriate. Each customer should work with legal counsel to identify categories of exclusion in the relevant country, but common categories of exclusion are wills and trusts, powers of attorney, and declarations given under oath.


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