The 21 CFR Part 11 is a Food and Drug Administration (FDA) regulation specifying the requirements for electronic records and signatures.
The purpose of 21 CFR Part 11 is to ensure the integrity, reliability, and authenticity of electronic records and signatures. This regulation applies to all FDA-regulated Life Science industries, including pharmaceuticals, biotechnology, and medical devices.
This article will provide an overview of 21 CFR Part 11 compliance, including who needs to comply, the main requirements, and the key steps to achieve compliance. We will also discuss how SimplerQMS can assist companies with FDA 21 CFR Part 11 compliance by showcasing some of its capabilities.
One way to ensure compliance with 21 CFR Part 11 regulations is to implement a 21 CFR Part 11 compliant eQMS software.
SimplerQMS provides eQMS software that is 21 CFR Part 11 compliant and tailored for Life Science companies. Request a personalized demo and talk to our experts if you are interested in learning more about how SimplerQMS can streamline your quality management processes and support compliance with 21 CFR Part 11.
Learn about the 21 CFR Part 11 compliance by exploring these topics:
- What is 21 CFR Part 11?
- Who Needs To Comply With 21 CFR Part 11?
- FDA 21 CFR Part 11 Compliance Requirements
- Key Steps to Achieving Compliance With FDA 21 CFR Part 11
- How Can SimplerQMS Help With FDA 21 CFR Part 11 Compliance
- Frequently Asked Questions
What is 21 CFR Part 11?
The 21 CFR Part 11 is a set of requirements that set forth the criteria under which the FDA governs the use of electronic records and electronic signatures.
This regulation determines when the FDA considers electronic records and digital signatures trustworthy, reliable, and equivalent to paper records and handwritten signatures executed on paper. It also helps protect electronic records from tampering, unauthorized access, and falsification.
According to 21 CFR Part 11 section 11.3(b)(6), electronic record means any digital representation of information, such as text, graphics, data, audio, or pictures, created, modified, stored, retrieved, or shared by a computer system.
Furthermore, according to 21 CFR Part 11 section 11.3(b)(7), an electronic signature means a compilation of symbols or characters created or authorized by an individual as a legal equivalent to a handwritten signature.
By complying with the 21 CFR Part 11 regulation, companies in the Life Science industries can ensure the integrity and security of their electronic records. This is achieved by implementing controls and measures such as authentication, access controls, audit trails, and system validation.
The 21 CFR Part 11 regulation is important for Life Science companies to handle sensitive and critical product development and manufacturing data. This data must be kept accurate, confidential, and free from tampering or manipulation.
Who Needs To Comply With 21 CFR Part 11?
Compliance with 21 CFR Part 11 applies to any company operating in FDA-regulated industries that uses electronic records and electronic signatures. More specifically, this includes companies in the Life Sciences industry, such as biotechnology, pharmaceutical, CRO, medical device, and others.
Failure to comply with 21 CFR Part 11 can result in regulatory enforcement actions, such as non-conformances, warning letters, and fines.
The SimplerQMS’ QMS software is designed to help companies in the Life Sciences industry achieve compliance with 21 CFR Part 11. SimplerQMS provides a secure platform for managing electronic records and signatures and streamlining quality management processes.
We will discuss some of the features and capabilities that make SimplerQMS a reliable eQMS software for 21 CFR Part 11 compliance as we move on throughout this article.
FDA 21 CFR Part 11 Compliance Requirements
The Life Science industry is highly regulated, and compliance with the 21 CFR Part 11 is essential to ensure electronic records’ authenticity, integrity, and security.
This section will briefly discuss the key requirements of 21 CFR Part 11, providing an overview of the regulation’s sections and examples of how SimplerQMS helps meet these compliance requirements.
The information presented in this article is intended for educational purposes. It should not be relied upon as official regulatory guidance. Companies that aim to comply with 21 CFR Part 11 should consult the regulation for official guidance.
Scope (Section 11.1)
This section specifies which types of records, signatures, and computer systems must comply with the requirements outlined in 21 CFR Part 11.
The regulation applies to:
- Electronic records that are created, modified, maintained, archived, retrieved, or transmitted in FDA-regulated industries.
- Digital signatures and their records meet the requirements and are considered equivalent to handwritten signatures.
- Computer systems, including hardware and software, controls, and related documentation.
Additionally, companies must maintain computer systems, controls, and related documentation always available for FDA inspection.
Two more sections are included in the Subpart A of the 21 CFR Part 11 regulation, in addition to the Scope section.
The Implementation section (11.2) states that electronic records and digital signatures can be used instead of paper and traditional signatures, provided that the requirements stated in CPR Part 11 regulation are met.
The Definitions section (11.3) specifies the definitions and interpretations of terms used in the 21 CFR Part 11 regulation.
Controls for Closed Systems (Section 11.10)
A closed system refers to a digital environment where only authorized persons can access and manage the electronic records stored in the system.
Controls and procedures for authentication requirements must be in place to ensure the records’ integrity and confidentiality. Controls must prevent users from denying the authenticity of their electronic signatures and the documents they signed.
Such procedures and controls need to include the following:
- System validation for accuracy, reliability, consistent performance, and detecting invalid records
- Ability to generate accurate and complete records in human-readable and electronic forms
- Protection of records and easy retrieval during the retention period
- Limited access to authorized individuals
- Use of secure and time-stamped audit trails to record operator entries and actions
- The operational system checks to enforce proper sequencing of events
- Authority checks to ensure only authorized individuals can use the system
- Device checks to validate data input source
- Training and qualifications of personnel using the electronic record and electronic signature systems to perform their tasks
- Written policies to hold individuals accountable for actions initiated under their electronic signatures
- Controls for systems documentation distribution, access, revision, and change procedures.
SimplerQMS provides you with such controls and procedures. With closed-system architecture and built-in security controls, among other things, your electronic records and signatures can be trusted for authenticity, integrity, and security. Our solution simplifies the compliance process and helps your company remain in full compliance with 21 CFR Part 11.
Controls for Open Systems (Section 11.30)
An open system refers to a digital environment where the personnel responsible for the electronic records do not control access to the system.
Personnel responsible for creating, changing, storing, or sending electronic records must ensure that the records are genuine, accurate, and confidential.
The procedures and controls include those for closed systems, as well as other authentication requirements like document encryption and digital signature standards.
Check out the article explaining the difference between open and closed systems as per 21 CFR Part 11 to better understand these types of systems.
Signature Manifestations (Section 11.50)
This section outlines the requirements for the information regarding electronic signatures, such as the signature’s date, time, and purpose.
This information needs to be recorded and included in all forms of readable documents, such as electronic displays or printouts.
SimplerQMS provides electronic signatures that display all signatures and related information at the bottom of signed documents. The software system complies with the requirements of 21 CFR Part 11 by automatically capturing and recording important information, such as the signer’s name, date, time, and signature justification.
Signature and Record Linking (Section 11.70)
To prevent tampering, copying, or falsification of electronic records, digital and handwritten signatures must be linked to their respective records.
The relation between digital signatures and records aims to prevent any unauthorized changes or falsification by avoiding the removal, copying, or transfer of signatures to other documents.
SimplerQMS automatically links signatures to their respective records, which ensures complete traceability and accountability of actions.
For instance, electronic signatures are used to sign documents for approval. The system then automatically records actions taken in the document history log with the responsible person for changes, date, time, and document state. The link between the record and the signature of the responsible person cannot be broken.
General Requirements for Electronic Signatures (Section 11.100)
This section outlines the general requirements for electronic signatures to ensure their authenticity, integrity, and confidentiality.
Here are the general requirements:
- Each electronic signature must be exclusive to an employee and cannot be reused or assigned to another person.
- The employee’s identity must be authenticated before setting up a digital signature.
- Companies must certify to the FDA that electronic signatures are legally binding and equivalent to traditional handwritten signatures before using them. This certification requires a handwritten signature on a form.
SimplerQMS helps ensure compliance with these requirements by providing user authentication processes through unique login credentials. SimplerQMS also facilitates the creation of an Electronic Signature Agreement, verifying the user’s identity and demonstrating the legal equivalence of digital signatures to handwritten ones.
Electronic Signature Components and Controls (Section 11.200)
Electronic signatures that do not use biometrics must have at least two identification components, such as an identification code and a password.
The first signature in a series of signings during a single, continuous period of system access must use all electronic signature components. Subsequent signings must use at least one component, usually the password.
Only the owner of digital signatures is authorized to use them.
If someone other than the owner needs to use an electronic signature, the system must require the collaboration of at least two individuals.
SimplerQMS can be connected to Microsoft Azure Active Directory (Azure AD) for single sign-on and user data management. You can limit information access to authorized personnel by setting access levels to specific sites, projects, document types, such as SOPs, Meeting Minutes, and Work Instruction, and more.
With our solution, you can have a streamlined workflow that automatically prompts signatures when required, facilitating document sign-off where each user has a unique identification code and password.
If you’re interested in learning more about the requirements for electronic signatures under 21 CFR Part 11, be sure to check out our in-depth guide on this topic.
Controls for Identification Codes and Passwords (Section 11.300)
Controls must be established to secure and maintain the integrity of electronic signatures that are based on identification codes and passwords.
The following controls must be implemented:
- Each combination of identification code and password must be unique to avoid duplication.
- Identification codes and passwords must be periodically reviewed, recalled, or updated to prevent password aging.
- Loss management procedures must be implemented to prevent access to devices containing identification codes or password information if they are lost or stolen.
- Unauthorized use of passwords and identification codes must be prevented, and any unauthorized attempts must be reported immediately.
- Devices containing or generating identification codes or passwords, such as tokens or cards, must be regularly tested to ensure their proper functioning and to detect any tampering.
SimplerQMS software helps Life Science companies improve data security through implemented procedures and controls that safeguard data privacy and confidentiality.
The software system includes security measures such as regular password updates. In SimplerQMS, users are required to update their password every three months and follow complexity requirements when creating the new one.
If you are interested in learning more about controls of identification codes and passwords, check out our full guide on 21 CFR Part 11 password requirements.
Key Steps to Achieving Compliance With FDA 21 CFR Part 11
Achieving compliance with the 21 CFR Part 11 regulation can be a complex process, requiring careful planning, implementation, and ongoing management.
Below, we outlined some of the key steps companies can take to comply with 21 CFR Part 11:
- Determine if 21 CFR Part 11 applies to you: First, determine whether your electronic records and signatures are subject to the requirements of 21 CFR Part 11 using applicability assessment.
- Conduct a risk assessment: Assess risks associated with electronic records and signatures and implement additional controls to ensure accuracy, reliability, and security.
- Create written policies and procedures: Develop written policies and procedures that define how electronic records and signatures are managed and controlled as per 21 CFR Part 11 requirements.
- Verify user identity: Verifying user identity ensures that only authorized personnel have access to sensitive information and reduces the risk of data and security breaches.
- Implement access controls: Implementing access controls is essential to ensure that electronic records and signatures are only accessible by authorized personnel.
- Establish electronic signature manifestation: Create unique electronic signatures containing the signer’s printed name, date, time, and purpose. And have all this signature information displayed on your records.
- Link signatures to records: Connect signatures to electronic records to prevent tampering, copying, or transferring the signatures.
- Provide training to personnel: Personnel who use electronic records and signatures must receive training to do their assigned tasks. Training needs to cover the policies and procedures related to 21 CFR Part 11 and the risks of non-compliance.
- Ensure documents are easily retrievable: Use advanced search capabilities to quickly locate specific electronic records based on keywords, document type, or other relevant criteria.
- Implement audit trails: Create secure, computer-generated, and tamper-proof audit trails that record all actions related to electronic records and signatures. The audit trails must also include time stamps.
- Conduct validation testing: Perform validation testing to ensure that electronic records and signatures are secure, reliable, and accurate. This process may involve testing hardware, software, or other systems.
- Generate copies of records: Have the ability to generate accurate and complete copies of records in both human-readable and electronic forms.
- Maintain documentation readily available: Maintain documentation related to compliance with 21 CFR Part 11, ready for review and inspection. This includes policies and procedures, validation testing results, audit trails, etc.
- Conduct periodic reviews: Periodic reviews of electronic records and signatures must be conducted by companies to ensure ongoing compliance with 21 CFR Part 11. Such reviews can be performed through internal audits or by external auditors.
- Update passwords periodically: Maintain identification codes and passwords regularly reviewed, recalled, or updated to ensure data security.
It is important to plan the necessary steps to achieve compliance and implement robust policies and procedures that comply with the requirements of 21 CFR Part 11.
By doing so, Life Science companies can mitigate the risks associated with non-compliance, streamline their electronic records and signatures processes, and ensure the safety and efficacy of their products.
Please note that the list of key steps provided is not fully comprehensive and that companies must refer to the 21 CFR Part 11 regulation for official information.
How Can SimplerQMS Help With FDA 21 CFR Part 11 Compliance
A QMS software solution like SimplerQMS helps achieve FDA 21 CFR Part 11 compliance since it provides a comprehensive framework for managing electronic records and digital signatures in a secure and compliant manner.
SimplerQMS includes features specifically designed to comply with Life Science requirements, including 21 CFR Part 11.
Here are some of the key features that help companies achieve FDA 21 CFR Part 11 compliance:
SimplerQMS provides robust document management capabilities, allowing companies to easily create, store, organize, and retrieve electronic records. Besides being a 21 CFR Part 11 compliant document management system, it also provides version control, automated document numbering, automated workflows, document change control management capabilities, and much more.
With SimplerQMS, companies can easily capture signatures digitally, which provides greater security and eliminates the need for physical signatures. Our 21 CFR Part 11 compliant electronic signatures are linked to electronic records, ensuring document authenticity, integrity, and confidentiality.
User Access Control
The user access control features ensure that only authorized personnel can access sensitive data. SimplerQMS uses Microsoft Azure Active Directory (Azure AD) for single sign-on and user data management. The system allows companies to define access levels and permissions for each user based on their roles and responsibilities.
Time-Stamped Audit Trails
SimplerQMS solution automatically records all user actions taken, providing a complete audit trail of who did what, when, and why. This feature is essential for compliance with 21 CFR Part 11, allowing companies to independently record the date and time of user actions related to electronic records.
The SimplerQMS software is fully validated according to ISPE GAMP5 and undergoes rigorous validation processes, including testing and documentation, to ensure the accuracy, reliability, and security of electronic records and signatures as per 21 CFR Part 11.
Training and Support
We provide training to ensure that SimplerQMS users are familiar with the system and know how to use electronic records and signatures to perform assigned tasks.
Furthermore, the integrated training management module facilitates employee training management and tracking. For instance, using SimplerQMS Training Managers can assign, track, and monitor all employee training related to 21 CFR Part 11 compliance or manage training related to specific processes or departments.
SimplerQMS offers a complete eQMS solution, including all Life Science QMS modules, such as document management, employee training, change control, CAPA management, complaint management, audit management, supplier management, and others.
These modules are integrated and designed to work together seamlessly, providing a comprehensive solution to help companies comply with the Life Science industry regulations and standards, including 21 CFR Part 11.
The software is also designed to streamline processes and improve efficiency, saving time and resources while helping ensure quality and compliance.
If you are considering implementing an eQMS solution in your company but are unsure of the benefits, we recommend downloading our eQMS Business Case template.
This resource provides a framework for analyzing the value of an eQMS for your company and can assist you in presenting your findings to management.
Building a business case can help you identify the potential return on investment (ROI) of implementing an eQMS solution, including cost savings, improved efficiency, and better compliance with regulations, such as 21 CFR Part 11.
By using our template, you can ensure that you have considered all relevant factors and make a convincing case for implementing an eQMS in your company.
Frequently Asked Questions
What Is FDA 21 CFR Part 11 Compliance?
FDA 21 CFR Part 11 compliance means that an FDA-regulated company follows the requirements outlined in Title 21 of the Code of Federal Regulations (CFR), Part 11. This includes employing procedures and controls to ensure the security, integrity, and confidentiality of electronic records and signatures, among other things.
What Are the Key Components of 21 CFR Part 11 Compliance?
Some of the key components of 21 CFR Part 11 compliance include:
- Validation: The validation process helps ensure that an electronic system operates as intended and produces accurate and reliable data. It involves documenting system requirements, testing procedures, and results, among other things.
- Electronic signatures: Electronic signatures are used to sign electronic records. They must be unique to each person and hold the same legal weight as a handwritten signature.
- Access controls: Access controls limit electronic record access to authorized individuals. This includes user authentication, password protection, and permissions.
- Audit trails: Audit trails are used to track all actions related to electronic records, including the responsible person, the date and time of the action, the reason, and other elements.
- Security: The electronic system should have security measures to safeguard against unauthorized access, falsification, or destruction of electronic records.
- Training: All personnel who use the electronic system must be trained on the system’s proper use, including electronic signature and record-keeping procedures.
- Documentation: All electronic records and documents must be appropriately managed and documented.
What Are the Consequences of Non-Compliance With 21 CFR Part 11?
The consequences of non-compliance with 21 CFR Part 11 in FDA-regulated industries may include the company being deemed illegal and subjected to significant penalties, such as non-conformances, warning letters, and fines.
How Does Computer System Validation Fit Into 21 CFR Part 11 Compliance?
Computer system validation (CSV) is a key component of 21 CFR Part 11 compliance. It involves documenting, following the test scripts, and verifying if the computer systems comply with the regulatory requirements for electronic records and signatures.
The process is documented as per Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) procedures.
Still, SimplerQMS eliminates validation concerns from the customers, as it is fully validated and continuously re-validated for ongoing compliance with Life Science requirements.
The 21 CFR Part 11 is a regulation outlining the requirements for electronic records and digital signatures enforced by the FDA.
The regulation aims to ensure that electronic records and signatures are trustworthy and reliable. It covers requirements for closed and open systems, signature manifestations, signature and record linking, and general electronic signature requirements.
Nowadays, many more Life Science companies have adopted 21 CFR Part 11 compliant document management and/or QMS software solutions to help manage their processes more effectively while ensuring compliance.
SimplerQMS provides a QMS software solution with state-of-the-art document management capabilities that comply with 21 CFR Part 11. It includes electronic signature and data integrity controls, password and identification code management, and generates audit trails of actions performed within the system, among many other things.
SimplerQMS offers a solution that can help make 21 CFR Part 11 compliance easier. You can streamline your quality processes and reduce the risk associated with non-compliance.
If you are interested to learn more, you can schedule a free demo with one of our experts to get a tailored view of our system and get answers to questions you may have about the solution.