Security & Compliance

What is UETA and the ESIGN Act?

The Uniform Electronic Transactions Act (UETA) and the Electronic Signature in Global and National Commerce Act (ESIGN Act) are pivotal U.S. laws that establish the legal validity of electronic signatures and records. Both statutes ensure that electronic documents and signatures are as legally binding as their traditional counterparts.

• Legal Validity: Electronic signatures and records are considered legally valid and have the same legal status as handwritten signatures and paper documents, ensuring that contracts and agreements formed electronically are enforceable.
• Electronic Records: Electronic records are deemed to be in writing and are legally recognized, satisfying the requirement for a written document.
• Consumer Consent: Parties involved in electronic transactions must consent to conduct the transaction electronically. However, consent cannot be denied solely on the grounds that it is in electronic form.
• Record Retention: UETA establishes guidelines for the retention of electronic records to ensure that they remain accessible and accurate for future reference.

What is eIDAS?

The Electronic Identification, Authentication and Trust Services (eIDAS) regulation is an EU initiative that standardizes electronic identification and trust services for electronic transactions. It ensures that electronic interactions between businesses, citizens, and public authorities are secure, seamless, and have legal standing.

eIDAS defines three levels of electronic signature, each with a different degree of security and legal weight:

• Simple Electronic Signature (SES): The entry level, suitable for everyday agreements where a straightforward electronic signature is enough to capture intent.
• Advanced Electronic Signature (AES): Uniquely linked to and capable of identifying the signer, created with signature data kept under the signer's sole control, and tied to the document.
• Qualified Electronic Signature (QES): The highest level, backed by a qualified certificate from a Qualified Trust Service Provider, giving the signature the same legal status as a handwritten one across the EU.

What is GDPR?

The General Data Protection Regulation (GDPR) is a regulation introduced by the European Union to protect the privacy and personal data of its citizens. It sets forth guidelines for the collection, processing, and storage of personal data and emphasizes transparency, security, and accountability by businesses.

What is 21 CFR Part 11?

21 CFR Part 11 is a set of regulations established by the U.S. Food and Drug Administration (FDA) that define when electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. These regulations ensure that electronic documents are secure, authenticated, and stored with integrity.

• System Validation: Systems managing electronic records must be validated to ensure accuracy, reliability, and consistent performance.
• Audit Trails: Secure, computer-generated, time-stamped audit trails record all modifications made to electronic records.
• Electronic Signatures: Electronic signatures must be unique to each individual and verified to ensure their authenticity.
• Record Retention: Electronic records must be stored and retrievable in a compliant format for the required retention period.