In 21 CFR Part 11, the Food and Drug Administration (FDA) establishes its requirements for electronic records and signatures. The regulation is intended to permit the widest possible use of the technology while ensuring the integrity and security of electronic records and signatures, ultimately supporting the Food and Drug Administration’s responsibility to protect public health.

Ethicsign eSignature is used by pharmaceutical and medical device companies to meet a range of compliance requirements, including those set forth in the Code of Federal Regulations Title 21 Part 11.

Organizations that are subject to 21 CFR Part 11 are those regulated by the FDA and/or engage in activities related to FDA-regulated products. They typically include the following industries:

• Pharmaceutical companies

• Clinical laboratories

• Biotechnology companies

• Medical device manufacturers

• Food and beverage manufacturers

• Cosmetics manufacturers

Although not all activities within these industries are regulated, it’s likely that some common activities do require compliance, and that the tools they use are compatible with requirements.

The FDA allows electronic signatures to be used in place of pen and ink signatures on paper documents so that business can be conducted digitally. In order to be compliant electronic signatures must include:

• The printed name of the signer

• The date and time the signature was executed

• A unique user ID

• Digital adopted signature

• The meaning of the signature (labeled “signing reason”)

The FDA also issued a guidance paper “Part 11, Electronic Records; Electronic Signatures — Scope and Application” to provide further clarification on electronic records and electronic signatures.