Electronic Signatures and 21 CFR Part 11

Electronic Signatures and 21 CFR Part 11 

In today’s regulated pharmaceutical environment, life sciences organizations are increasingly benefiting from the advantages of digital document management as many are choosing to implement electronic signature in place of traditional paper-and-ink signature processes for convenience. But convenience alone doesn’t meet the standards of the U.S. Food and Drug Administration. For companies working under FDA oversight, compliance with 21 CFR Part 11 is essential when using electronic signatures in place of handwritten ones. 

This regulation, originally introduced to enable digital recordkeeping and streamline processes, sets out specific requirements for ensuring that electronic signatures are trustworthy, reliable, and generally equivalent to handwritten signatures executed on paper. And getting this right isn’t just about avoiding warning letters—it’s about protecting data integrity, ensuring accountability, and building trust in digital systems. 
 

What 21 CFR Part 11 Requires for Electronic Signatures 

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. Part 11 specifies that signed electronic records shall contain information associated with the signing that clearly indicates all the following: 

• the printed name of the signer, 

• the date and time when the signature was executed, 

• the meaning associated with the signature (e.g. review, approval, responsibility, or authorship). 

When an individual executes a series of signings during a period of single, continuous controlled system access, the first signing must be executed using all electronic signature components, but repeated (subsequent) signings may be executed using one electronic signature component that is only executable by and designed to be used only by the individual. 

In addition, FDA wants to know that your electronic records and signatures can’t be altered without detection, that every signature is attributable to the right person, and that the entire process is protected from misuse. 

Here are the basics that companies must have in place: 

• Secure user authentication: Every person signing electronically needs a unique ID and password—or, in some cases, a biometric marker like a fingerprint. Two-factor authentication is increasingly common. 

• Audit trails: The system must automatically log who did what and when, without allowing the user to modify those logs. This creates a traceable history of every change, which is vital for audits and investigations. 

• Linking signatures to records: Each signature must be permanently connected to the electronic document it signs. There can be no ambiguity about who signed what and when. 

• Controlled access: Only authorized individuals should have the ability to sign electronically, and user permissions must be managed carefully. 

When these elements are missing or poorly implemented, a system may fail to comply—even if it technically allows for electronic signatures. 

Why Validation Matters 

A common misconception is that if a software vendor claims their product is 21 CFR Part 11 compliant, the company using it is automatically in the clear. That’s not the case. The FDA holds the regulated company—not the software vendor—responsible for proving that the system works properly in its intended environment. 

This is where electronic signature validation in pharma comes into play. The validation process involves testing the system under real-world conditions to confirm that it behaves as expected, meets regulatory requirements, and maintains data integrity. 

Without thorough validation, even a well-designed system can become a compliance liability. 

Partnering with Arbour Group for Compliance 

For companies navigating these complex requirements, Arbour Group offers specialized support. Our validation services are designed to ensure that electronic signatures in FDA-regulated systems are implemented correctly, documented thoroughly, and aligned with business and regulatory needs. 

We help clients: 

• Perform thorough risk assessments for electronic signature systems. 

• Validate electronic systems from end to end. 

• Create audit-ready documentation that satisfies FDA expectations. 

With decades of experience supporting life sciences companies, Arbour Group brings clarity and confidence to an area where small missteps can lead to big consequences.  

By understanding what 21 CFR Part 11 electronic signature rules require—and by validating your systems with care—you can make that transition smoothly and securely. And with the right partner, like Arbour Group, you don’t have to figure it all out alone. 

Ready to ensure your electronic signature systems are fully 21 CFR Part 11 compliant? Contact Arbour Group today to learn how our expert validation services can help you stay compliant, audit-ready, and confident in your digital processes.