If you work in a regulated industry like pharmaceuticals, biotech, or medical devices, you’re probably familiar with 21 CFR Part 11.

This regulation is part of Title 21 of the Code of Federal Regulations (CFR), which covers U.S laws on food and drugs. Part 11 explains the FDA’s rules for using electronic records and electronic signatures and outlines when and how they are equivalent to paper records and handwritten signatures.

Basically, the FDA is saying that your use of digital systems to manage regulated information needs to be just as trustworthy and secure as traditional paper records and signatures.

This means your systems need to have controls for data integrity, security and traceability. The result? Keeping all your records accurate, complete, and verifiable.

Who must comply and why it matters

Any business that falls under FDA jurisdiction and that stores, submits, and manages records electronically needs to comply with 21 CFR Part 11.

That would include:

• Pharmaceutical companies that conduct clinical trials or manages manufacturing data
• Biotech firms that maintain research or batch records
• Medical device manufacturers that use digital systems for design and testing documentation
• Contract research organizations (CROs) that handle electronic study data for sponsors

Essentially, Part 11 applies to you if your digital records are part of a regulated process like clinical trials, drug manufacturing, device design, etc.

Why does this matter?

When you’re non-compliant, you open your business to operational risks. You can also impact document integrity, regulatory approval, audit readiness, and public trust. If your electronic records are deemed unreliable or poorly controlled by the FDA, you’ll likely have to deal with inspection findings, warning letters, or even delays in product approval.

But it’s worth noting that the FDA interprets the scope of Part 11 narrowly and shows enforcement discretion for some parts of it. In a lot of cases, the rule primarily applies when electronic records are used instead of paper records required by other FDA regulations (often called “predicate rules”).

But keeping paper master records doesn’t automatically exempt you, so if you use electronic copies for any regulated work, they still need to meet Part 11 standards.

Key requirements and controls under Part 11

Part 11 is divided into three main sections:

• Subpart A (General Provisions)
• Subpart B (Electronic Records)
• Subpart C (Electronic Signatures)

Let’s break down what each part covers and what it means in practice.

Subpart A: General provisions

This is the section that defines the rule’s purpose, scope, and implementation. It explains that electronic records and signatures can be considered acceptable if they meet certain standards for authenticity, integrity, and confidentiality.

That means that if you’re using an electronic system for regulated activities, you have to include built-in protections to prevent any tampering or unauthorized access to those records.

Subpart B: Electronic record controls

This part of the regulation explains how to manage and protect your electronic records. Here are the key requirements they list:

• System validation: Your system has to be validated so that it consistently performs as it’s intended. That means making sure it accurately records, stores, and retrieves information without errors through testing. You have to perform your own computer system validation (CSV) to make sure it works for your intended use. Plus, you should use vendor documentation as supporting evidence.
• Audit trails: Any changes to a record has to be automatically logged with who made the change, when the change was made, and what exactly was changed. Audit trails should be kept so that records can be periodically reviewed for quality assurance.
• Access controls: It’s key that only authorized users can create, modify, or approve records. So, electronic systems should always enforce role-based permissions and secure authentication.
• Record retention: Electronic records need to be easily retrievable throughout the required retention period, even when software or hardware are updated.
• Documentation and SOPs: Standard operating procedures (SOPs) should explain how records are created, reviewed, and maintained. They should also show how systems are validated and audited.

Subpart C: Electronic signature requirements

This section covers how to make sure electronic signatures are legally equivalent and as verifiable as handwritten ones.

Here are the key requirements:

• Unique identification: All signers have to have a unique user ID and password combination.
• Authentication controls: Users have to use secure, controlled methods to verify their identity when signing. While the rule doesn’t say you have to use a specific technology, multi-factor or two-step authentication is a widely accepted best practice.
• Signature manifestation: All signatures need to clearly have the signer’s name, date/time, and meaning of the signature, like review, approval, responsibility, etc.
• Linking signatures to records: Signatures have to be permanently linked to their respective electronic records to prevent removal or reuse.

These things will help make sure electronic signatures are authentic and verifiable.

How to be compliant with 21 CFR Part 11

Becoming compliant with 21 CFR Part 11 is not as intimidating as it might sound. If you have the right processes and technology in place, you can do it.

Here’s how you can get started:

1. Validate your systems
   Getting documented system validation is a critical step in becoming compliant. You should start by conducting risk-based testing to make sure your software performs consistently and accurately for its intended use.
   
2. Establish SOPs and documentation
   You should create and keep procedures that explain how you will create, review, modify, and archive electronic records within your system. You also need to make sure your team knows exactly what’s expected at every step.
   
3. Implement audit trails
   Invest in software that can automatically track all user actions and changes. Then, make sure to review audit trails regularly to see if there are anomalies or unauthorized activity. Keep your audit trails as long as you have the associated records.
   
4. Set up access controls and authentication
   Access to documents should be limited to specific roles and responsibilities. You should also enforce strong password policies and authentication methods to keep everything secure.
   
5. Train your users
   If your users don’t understand the rules, the system won’t be beneficial to anyone. Make sure to have regular training on compliant system use, data entry, and signature protocols for your teams.
   
6. Conduct periodic reviews
   Remember that compliance is an ongoing commitment. This means you need to regularly audit your systems and documentation so that you’re always compliant with Part 11 and any updated FDA guidance.

If you need more guidance, you can always reference industry checklists or vendor-provided compliance documentation.

Plus, if you want to dive deeper into best practices for maintaining reliable, compliant documentation, check out our guide on good documentation practices.

PandaDoc features that support CFR Part 11 compliance

PandaDoc offers several key features that align with the main requirements of 21 CFR Part 11 and supports compliance-ready workflows:

• Comprehensive audit trails: With PandaDoc, all your docs have a complete record of user actions, including when it was opened, viewed, and signed. This helps maintain traceability.
• Access controls and role-based permissions: Your admins can define who can view, edit, or sign documents, which helps restrict unauthorized access.
• eSignature compliance: PandaDoc eSignatures comply with ESIGN and UETA, ensuring your documents are legally valid and enforceable.
• Signature intent, user authentication, and verification: To help you meet Part 11 standards, PandaDoc lets you enable features like signer intent acknowledgment, unique user IDs, and multiple recipient verification options—including SMS, passcode, knowledge-based authentication (KBA), and ID checks.
• SOC 2 Type II certification: Our platform meets high standards for data security, availability, and confidentiality with this certification.

It’s important that, if you’re working under FDA regulations, you should also validate your own use of PandaDoc, create clear SOPs for how it’s used in regulated processes, and keep PandaDoc’s documentation and test records as part of your business’s compliance files.

Want to see how PandaDoc helps you meet every requirement of 21 CFR Part 11? Learn more about our compliance-ready eSignature features.

Final thoughts

21 CFR Part 11 compliance is all about maintaining trustworthy, auditable, and secure digital records in regulated industries, where data integrity is paramount.

This regulation helps you keep your electronic systems safer for your business and your customers. Tools like PandaDoc can help you secure your workflows and achieve compliance, making your data more reliable.

Want to see how PandaDoc works in action? Request a free demo today.