21 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 a 21 CFR Part 11 Module.

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”)

How does the E-Sign 21 CFR Part 11 Module support compliance?

E-Sign has a 21 CFR Part 11 Module available that ensures compliance with 21 CFR. The Module is a free module available with an Enterprise Licence. 

One of the main requirements of 21 CFR Part 11 is that the document must provide a reason for signature/signing reason such as ‘I approve this document’, ‘I have reviewed this document’, or ‘I am the author of this document’. The new module being implemented by eSign allows recipients to confirm their reason for signing as well as meeting the other requirements of the regulation which are:

• The printed name of the signer
• A unique user ID
• The date and time of the signature
• Digital adopted signature

Other requirements also include:

• Each eSignature must be unique to only one individual and not reused by anyone else
• The identity of the signer must be verified before the electronic signature is applied
• There must be additional evidence from the e-signature provider that certify that the signature is legally binding
• If the signature is not based on biometrics, it must use two distinct components for identification such as an ID code and password
• The eSignature platform used must have safeguards in place to prevent unauthorised access to documents and stop unpermitted use of identification codes and passwords

eSign Managing Director, Thomas Taylor, said: 

“By optimising our electronic signatures with the 21 CFR Part 11 Module, we can provide our services to more FDA regulated businesses and organisations within the life sciences sector. Offering them complete assurance that their document transactions are fully compliant with the relevant regulations that apply to their industry, and achieving our goals of supporting organisations with their digital transformation journey.”

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 FDA regulations. Electronic signatures 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 21 CFR Part 11 Module page.

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