Navigating 21 CFR Part 11 Compliance for Electronic Signatures in Life Sciences

For many life sciences organizations, paper-heavy processes like scanning documents or obtaining handwritten signatures remain bottlenecks within otherwise automated workflows. This hybrid approach often undermines the very speed and security that digital systems are meant to provide. 

The challenge is that many legacy technologies fail to meet all FDA regulatory requirements while also providing the trust, security, and operational uptime needed to support holistic digital transactions. The Docusign Intelligent Agreement Management (IAM) platform is designed to bridge this gap.  

This post shares the key electronic records requirements included in 21 CFR Part 11, and explores how companies are leveraging Docusign capabilities to maintain compliance and enhance productivity.

What is 21 CFR Part 11?

Life sciences organizations regulated by the FDA must adhere to the Code of Federal Regulations Title 21 Part 11 opens in a new tab. Introduced in 1997, this framework supports the transition from paper-based to electronic systems. Part 11 applies to any electronic record that is created, signed, modified, maintained, archived, retrieved, transmitted, or submitted under FDA regulations/predicate rules. 

Risks of non-compliance

Failure to comply can result in severe penalties, including: 

• FDA Form 483 inspectional observations

• Warning letters and public citations

• Significant delays in product submissions under the Federal Food, Drug, and Cosmetic Act

In 2003, the agency issued a guidance paper, “Part 11, Electronic Records; Electronic Signatures — Scope and Application opens in a new tab,” to provide further clarification on electronic records and electronic signatures.

Since then, the requirements under Part 11 have not changed. What has changed is the FDA’s focus on how companies demonstrate compliance in increasingly digital, cloud-based, and data-driven operational environments. 

For example, in 2025, the FDA specifically warned the medical device industry opens in a new tab about unreliable data generated by third-party testing labs. The FDA expects covered organizations to demonstrate that their systems are Part 11-compliant and that the underlying data is complete, accurate, attributable, and trustworthy throughout its lifecycle.

Who must comply with 21 CFR Part 11?

Regulatory requirements apply to any organization engaging in FDA-regulated activities. This group typically includes:

• Pharmaceutical and biotechnology companies

• Medical device manufacturers

• Contract research organizations (CROs) and Contract manufacturing organizations (CMOs)

• Clinical laboratories

• Food, beverage, and cosmetics manufacturers

Although not all activities within these industries are regulated, some common activities are, and the tools they use must meet the requirements.

What are the requirements for compliant electronic signatures?

The FDA allows electronic signatures to replace traditional pen-and-ink signatures. Under Part 11, every electronic signature must include:

• Printed name of the signer

• Date and time of the signature

• Unique user ID

• Digital adopted signature

• The “signing reason” (such as review, approval, or authorship)

How Docusign supports 21 CFR Part 11 compliance

Docusign enables life sciences organizations to digitize complex GxP workflows systematically. By using the Docusign Life Sciences Module, organizations can reduce review cycle times while ensuring every signature is legally binding and audit-ready. 

Key security features: 

• Encryption: Data is encrypted both in transit and at rest

• Every transaction generates a tamper-proof audit trail and certificate of completion

• Global standards: Docusign is ISO 27001:2013 certified, providing the highest level of information security  

The Life Sciences Module includes three components designed to meet Part 11 requirements, including:

1. An eSignature solution that includes:

   1. Prepackaged account configuration

   2. Signature-level credentialing   

   3. Signature-level meaning (signing reason)

   4. Signature manifestation (printed name, date/time, and signing reason)

2. The ability to authenticate signer identity via SMS text message, in addition to email-based verification

3. A validation solution that streamlines ongoing validation requirements to adhere to GxP standards 

The Life Sciences Module is a product enhancement available for Docusign’s life sciences customers. It includes additional security and controls, resulting in a different signing experience relative to non-regulated use cases.

The Life Sciences Module is available for Enterprise editions of Docusign. It cannot be provisioned from accounts purchased on Docusign.com. Contact sales for more information on purchasing and setup.

Ready to get therapies and devices to market faster? Read our comprehensive guide to simplifying 21 CFR Part 11 compliance