CFR Pt. 11 Compliance with Electronic Signatures

The Food and Drug Administration (FDA) outlines its requirements for electronic records and e-signatures in 21 CFR Part 11, which are intended to allow the widest possible use of electronic technology in line with the FDA’s duty to safeguard public health. At E-Sign, we’ve ensured that our e-signature and document management platform are compliant with these regulations.

What is 21 CFR Part 11?

Title 21 CFR Part 11 is part of the Code of Federal Regulations that outline the FDA stance on electronic records and e-signatures. The term “Part 11” relates to electronic records that are ‘created, modified, maintained, archived, retrieved, transmitted or submitted’. All life science organisations and device manufacturers are regulated by the FDA and are therefore obligated to follow the Code of Federal Regulations Title 21 Part 11.

What Does 21 CFR Part 11 Mean for Electronic Signatures?

The FDA allows electronic signatures to be used in place of traditional paper-based signatures, allowing business to be conducted digitally. In order to be compliant with this regulation, electronic signatures must include:

• The printed name of the signer
• The date and time of the signature
• A unique user ID
• Digital adopted signature
• The meaning of the signature (“signing reason”)

What Are the Other Requirements for Electronic Signatures?

To be CFR compliant, our electronic signatures also have to meet the following requirements:

• Must be unique to one individual and not used by anyone else.
• Must verify the identity of the signer.
• Must offer additional certification or testimony to specify that its legally binding.
• Must provide at least two distinct identification components e.g. identification code/ password.

E-Sign for Life Sciences

At E-Sign, we realise that life sciences have never been more important to our health and society. That’s why we want to ensure that our e-signature platform is compliant with the USA’s CFR regulations. Digital technology and electronic signatures can help to improve efficiency for businesses and organisations, providing time and money saving ways of working that truly work for you, your employees and organisation- all while remaining compliant with CFR regulations.

E-Sign offers all the functions you need to remain compliant with the CFR and utilise a secure and legally binding signature in your life sciences organisations.

For more information about E-Sign’s legality and compliance, visit our legality page.

To find out more about our E-Sign solutions and how they could transform your business, get in touch with us today.