eSign Introduces New 21 CFR Part 11 Module

At eSign we’re continually striving to improve the products and services we provide to maximise our regulatory compliance, and therefore reach new organisations across different industries. With that in mind, we’re excited to announce that we are introducing a new module to our platform that ensures complete compliance with 21 CFR Part 11. 

What is 21 CFR Part 11?

Title 21 of the Code of Federal Regulations (CFR) is the section that details the FDA’s stance on the use of electronic records and eSignatures in life science organisations and device manufacturers. Part 11 specifically refers to electronic records that are ‘created, modified, maintained, archived, retrieved, transmitted, or submitted’. The regulation reflects the digital transformation that has been taking place within the life sciences sector. 

This evolution originally came with challenges as there wasn’t a technology available that could meet the FDA regulatory requirements and provide full trust and security to support organisations with their digital needs. Especially in relation to managing transactions and working with external stakeholders. 

eSign’s new 21 CFR Part 11 Module meets compliance requirements and provides life sciences organisations with the confidence and digital tools they need to use e-signatures and electronic documents in a secure and compliant way. 

How does the new E-Sign module support CFR compliance?

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 new 21 CFR Part 11 Module, we will be able to 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.”

You can find out more about eSign’s compliance with 21 CFR Part 11 by contacting our digital transformation team. We can provide tailored guidance on how eSign can meet the specific requirements of your organisation and provide a cost effective and compliant solution that can be seamlessly implemented into your workflows.