21 CFR Part 11 Compliant Electronic Signatures (Guide)

21 CFR Part 11 compliant electronic signatures refer to digital signatures that meet the Food and Drug Administration (FDA) 21 CFR Part 11 regulation requirements.

Their goal is simple: to ensure that the signatures and signed documents are trustworthy, reliable, and equivalent to a document with handwritten signatures executed on paper.

This article covers the key requirements, benefits, and best practices of implementing 21 CFR Part 11 compliant electronic signatures. Additionally, it discusses how an electronic QMS solution like SimplerQMS offers full 21 CFR Part 11 compliance.

Learn about 21 CFR Part 11 compliant electronic signatures by exploring these topics:

• Understanding 21 CFR Part 11
• Key Requirements for Electronic Signatures to be 21 CFR Part 11 Compliant
• Best Practices for Implementing 21 CFR Part 11 Compliant Electronic Signatures
• Benefits of Implementing 21 CFR Part 11 Compliant Electronic Signatures
• How SimplerQMS Meets 21 CFR Part 11 Electronic Signature Requirements

Understanding 21 CFR Part 11

The FDA 21 CFR Part 11 is a part of the regulation issued by the FDA that outlines the requirements for electronic records, electronic signatures, and computer systems. It applies to FDA-regulated companies, such as the ones operating in the pharmaceutical, biotechnology, medical device, and other Life Science industries, that want to market their products in the United States.

21 CFR Part 11 aims to ensure electronic records’ authenticity, integrity, and confidentiality when appropriate. It also ensures that the signer cannot reject the signed record as not genuine.

Electronic signatures, as defined by 21 CFR Part 11, are a collection of symbols or series of symbols created or authorized by an individual that serves as a legally binding equivalent to their handwritten signature.

Compliance with 21 CFR Part 11 is essential to ensure data integrity and security of electronic records and avoid potential regulatory issues, such as non-conformances, fines, or legal action.

To learn more about the key steps and requirements for achieving compliance, read our guide to 21 CFR Part 11 compliance.

Key Requirements for Electronic Signatures to be 21 CFR Part 11 Compliant

As electronic signatures play a vital role in ensuring electronic records’ authenticity, integrity, and security, companies must understand all the applicable requirements.

You can watch the video below to quickly understand the principal requirements of electronic signatures according to the 21 CFR Part 11.

Then read on for a more detailed explanation of each requirement.

Below, we will discuss key requirements for digital signatures as per 21 CFR Part 11, along with examples of how a solution like SimplerQMS helps comply with these regulatory requirements.

Signature Manifestations (Section 11.50)

Electronic signatures must include the following:

• Signer’s printed name
• Signature’s date and time
• Signature’s purpose, such as review, approval, responsibility, or authorship.

Information regarding electronic signatures must be treated with the same controls as electronic records and must be included in all forms of readable documents, such as electronic displays or printouts.

SimplerQMS provides electronic signatures that automatically capture and record essential information in compliance with the requirements of 21 CFR Part 11.

This includes the signer’s name, date, time, and signature justification.

All signatures and associated information are displayed at the bottom of the signed documents as well as the metadata, creating a clear and comprehensive record of the electronic signature process.

Signature and Record Linking (Section 11.70)

Electronic and handwritten signatures on electronic records must be linked to their respective records to prevent tampering, copying, or falsification.

You can ensure the authenticity of electronic signatures and manage electronic records with the SimplerQMS solution. Our system automatically links digital signatures to the respective electronic records, ensuring complete traceability and accountability of actions.

This link prevents electronic signatures from being removed, copied, or transferred to other documents, preventing unauthorized alteration or falsification.

General Requirements for Electronic Signatures (Section 11.100)

In order to comply with 21 CFR Part 11, several general requirements must be achieved for electronic signatures.

Here is a summary of these requirements:

• Each electronic signature must be unique to an employee and not be reused or reassigned to anyone else.
• The employee’s identity must be verified before the company sets up an electronic signature.
• Before using digital signatures, companies must certify to the FDA that such signatures are legally binding and equivalent to traditional handwritten signatures. A certification form must be signed with a traditional handwritten signature.

SimplerQMS software complies with 21 CFR Part 11 by providing user authentication with unique user logins and passwords.

Users can easily review, approve, and sign off documents from any device, location, and anytime.

We also offer a document template to assist you in creating an Electronic Signature Agreement to demonstrate the equivalence of handwritten and electronic signatures.

Electronic Signature Components and Controls (Section 11.200)

This section outlines electronic signatures’ components and control requirements, including biometric signatures.

It is important to ensure that digital signatures require at least two different identification factors, such as a password and an identification code.

Every time users log into the system, they must use all these components when signing documents for the first time.

However, when executing multiple signatures during a single system access, the initial signature must have user identification and password. For subsequent signings, at least one component, usually the password, must be used.

SimplerQMS software helps Life Science companies ensure users have unique identification codes and passwords.

Out-of-the-box, SimplerQMS connects to Microsoft Entra ID (previously known as Microsoft Azure Active Directory) for cloud-based identity and access management, single sign-on, and multifactor authentication.

By utilizing the SimplerQMS 21 CFR Part 11 compliant document management system within a streamlined workflow that automatically prompts you for signatures when required, you can experience an effortless document sign-off process.

Controls for Identification Codes and Passwords (Section 11.300)

Controls must be implemented for electronic signatures based on identification codes and passwords to ensure security and integrity.

These controls must include the following:

• Ensure that each identification code and password combination is unique, with no user duplication.
• Ensure to periodically review, recall, or update the identification code and password, preventing password aging.
• Implement loss management procedures to revoke access for lost or stolen devices that contain identification codes or password information.
• Prevent unauthorized use of passwords and identification codes, and immediately report any attempt of unauthorized use.
• Regularly test devices, like tokens or cards, that contain or generate identification codes or passwords to ensure they work correctly and have not been tampered with.

SimplerQMS’s electronic signature functionality helps improve data security by employing procedures and controls designed to ensure data privacy and confidentiality.

This includes rigorous security measures like two-factor authentication, periodic password resets, and user access control.

In this section, we discussed the 21 CFR Part 11 requirements for electronic signatures. However, if you want to learn more also about electronic records and computer system requirements, you can read our article on 21 CFR Part 11 requirements for further information.

Best Practices for Implementing 21 CFR Part 11 Compliant Electronic Signatures

Successful implementation of 21 CFR part 11 compliant electronic signatures requires careful planning and execution. Best practices help implement electronic signatures as they provide a framework to follow.

Below are some examples of best practices for implementing electronic signatures:

• Conduct risk assessments and gap analyses: Identify and assess potential risks and gaps in your electronic signature processes and controls and develop mitigation strategies to address them.
• Create a compliance plan: Develop a comprehensive plan for implementing electronic signatures that comply with the requirements of 21 CFR Part 11.
• Select and implement the electronic signature solution: Choose a 21 CFR Part 11 compliant electronic signature solution that meets your specific needs and requirements.
• Verify user identity: Ensure that users are properly verified and certified before granting them access to sign-off electronic records.
• Assign signatures correctly: Ensure that digital signatures are unique to each user and cannot be used by anyone else.
• Train and educate personnel: Provide comprehensive training and education to personnel using electronic record/electronic signature systems to ensure they have the education, training, and experience to perform their assigned tasks.
• Maintain signature integrity: Ensure that eSignatures cannot be falsified or rejected as not genuine, maintaining valid and reliable signatures throughout the document’s lifecycle.
• Time-stamp and synchronize signatures: Ensure that electronic signatures are time-stamped and synchronized with a trusted time source to provide an accurate and reliable record of when the signature was applied.
• Link signatures to records: Link signatures to their associated records and ensure signatures cannot be copied or falsified.
• Track signature components: Ensure that electronic records with signatures include the signers’ printed name, date, time, and meaning of signature.
• Maintain an audit trail: Keep a comprehensive audit trail that records time-sequenced development and any change of systems documentation.
• Conduct audits and reviews: Regularly audit and review electronic signature processes and controls to ensure they remain effective and compliant with 21 CFR Part 11.

Using best practices like the ones above while implementing an electronic signature helps mitigate the risk of non-compliance, such as invalid signatures, which can lead to regulatory sanctions.

Moreover, such best practices can help companies save time and resources by streamlining the implementation process and ensuring all necessary components are in place.

Benefits of Implementing 21 CFR Part 11 Compliant Electronic Signatures

Implementing 21 CFR Part 11 compliant electronic signatures can offer several benefits to Life Science companies. Here are some of the main ones:

Improved Compliance

Firstly, by implementing procedures and processes for electronic signatures, outlined in 21 CFR Part 11, Life Science companies comply with these requirements.

Improved Security

21 CFR Part 11 compliant digital signatures offer higher security than traditional handwritten signatures since they use authentication methods such as passwords, identification codes, and tokens.

Cost Savings

Electronic signatures can help reduce the costs associated with paper-based processes, such as printing, sending the printed document to be signed, and storing physical documents.

Improved Data Integrity

Digital signatures can help ensure data integrity by creating an electronic audit trail that records who signed the document, when it was signed, and as well as what changes were made.

Increased Efficiency

Electronic signatures can streamline document approval processes, reducing the need for paper records and manual signature verification.

Enhanced Collaboration

The use of eSignatures enables individuals from different departments to collaborate on the same document and sign it remotely, regardless of their location. This help saves time and increases productivity.

How SimplerQMS Meets 21 CFR Part 11 Electronic Signature Requirements

With a strong focus on compliance with 21 CFR Part 11 and other requirements, SimplerQMS offers a comprehensive solution that allows companies to effectively manage their electronic records and sign-off documents using electronic signatures while ensuring compliance with FDA regulations.

You can watch the video below to see how 21 CFR Part 11-compliant electronic signatures work in SimplerQMS.

Below are some key points about how a solution like SimplerQMS can help you achieve compliance:

• Individual Electronic Signatures: Electronic signatures must be unique to the individual and their associated identification code. SimplerQMS software uses Microsoft Entra ID (previously known as Microsoft Azure Active Directory) to control signature components. Each signing credential is unique, with digital signatures having an exclusive user identification code and password combination.
• Verified User Identity: The user’s identity must be verified to ensure that the person signing the electronic record is authorized to do so. SimplerQMS provides the ability to create Electronic Signature Agreements, where employees certify that their eSignatures have the same legal value as a handwritten signature.
• Reporting to FDA: Electronic signatures must be notified to the FDA as part of the regulatory submission process. SimplerQMS facilitates this process by providing a template of the Letter of Non-Repudiation Agreement. An electronic copy of this letter and the Electronic Signature Agreements of employees must be submitted to the FDA to ensure compliance.
• Electronic Signatures Components: Signatures need at least two components: an identification code and a password. SimplerQMS system requires users to authenticate their identity with a unique username and password before signing a document, preventing unauthorized use of signatures.
• Displayed Signature Information: Electronic signatures must include the printed name of the signer, date, time, and the meaning of the signature. SimplerQMS automatically links this information to the respective electronic record and displays all the relevant signature information.
• Preventing Passwords Aging: Unique combinations of identification code and password are required for each user, and regular checks should be performed. SimplerQMS uses Microsoft Entra ID to ensure strong and secure passwords. Passwords expire every three months and must have at least eight characters, including one uppercase character, one lowercase character, and one digit.
• Lost Password Procedures: A procedure must be in place to handle lost, stolen, or missing passwords. SimplerQMS software helps you handle identification code or password information as well as issue replacements when necessary.
• Audit Trail and Traceability: 21 CFR Part 11 requires the ability to generate and retain accurate and complete records and eSignatures, in a secure and traceable manner. SimplerQMS provides comprehensive audit trails that capture all changes to documents, allowing for easy traceability and auditability of electronic records.
• Automated Workflow: Automating workflows and approval processes eliminates the need for manual signatures. This reduces the risk of errors or delays in obtaining signatures, ensuring that digital signatures are captured in a timely and compliant manner.
• Document Management: By implementing robust 21 CFR Part 11-compliant document management, companies can ensure secure, traceable, and readily accessible electronic records and signatures.

SimplerQMS offers complete Life Science QMS software with integrated modules, such as document control, change management, training management, CAPA management, supplier management, and others.

Our system is fully validated according to ISPE GAMP5 and undergoes re-validation when a new version is created or standard updates are applied. This includes testing and documentation to ensure compliance with the 21 CFR Part 11 regulation requirements.

If you are unsure about the benefits of implementing an eQMS in your company, check out our eQMS Business Case template, which can be downloaded below.

This resource can assist you in identifying the value of an eQMS for your company and provides the necessary material for presenting your findings to management.

Final Thoughts

21 CFR Part 11 is part of an FDA regulation specifying the requirements for using electronic records and electronic signatures.

Compliance with 21 CFR Part 11 is mandatory for companies that use electronic records and signatures to ensure the authenticity, integrity, and, when appropriate, confidentiality of electronic records.

Implementing 21 CFR Part 11 compliant software solutions with built-in eSignatures can help companies achieve regulatory compliance, improve data integrity, and increase efficiency while reducing costs.

SimplerQMS provides an eQMS solution with 21 CFR Part 11 compliant electronic signatures designed for Life Science companies. Our software helps improve efficiency and cost savings by streamlining quality management processes and reducing the need for paper-based documentation.

Book a free demo of the SimplerQMS solution and talk with our experts about streamlining your quality management processes and making 21 CFR Part 11 compliance easier.