Top FAQs on FDA 21 CFR Part 11 Compliance

As more companies move their processes into the digital space, new risks concerning the security of electronic records surface. In March of 1997, the United States Federal Food and Drug Administration (FDA) created CFR Part 11 to combat those risks. However, exactly what this standard entails and what the FDA expects can be confusing. To help companies navigate this regulation process, we’ve compiled a guide on the nine most common questions companies have when it comes to 21 CFR Part 11 compliance. Read on to learn more.

FDA 21 CFR Part 11 FAQs

The FDA defines 21 CFR Part 11 as the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Specifically, it’s guidance on how United States-based companies can submit documentation in an electronic form and the criteria for approved electronic signatures. The acronym CFR stands for “Code of Federal Regulations,” and Part 11 refers specifically to electronic signatures that are submitted to the FDA.

Generally, if your organization follows all the encompassed Part 11 requirements and can prove the validity of electronic signatures to an auditor, the FDA will accept those electronic signatures in place of traditional paper-based ones.

The FDA issued a guidance paper that provides further clarification on electronic records and electronic signatures: Part 11, Electronic Records; Electronic Signatures — Scope and Application

When the world began turning paper processes digital, the government needed a way to regulate electronic documents and preserve data authenticity. With the help of CFR Part 11, the FDA works to ensure that all digital records are properly kept and risk-free. Specifically, this regulation helps companies learn how to:

• • Store data safely and securely
  • Track data changes
  • Guarantee data is not corrupted or lost
  • Ensure that electronic signatures cannot be disputed
  • Prevent and identify falsified records

Generally, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, contract research organizations (CROs), and other FDA-regulated industries, with some specific exceptions. If you are part of any of these industries, this regulation applies to your company. 

In highly regulated industries like the ones Part 11 applies to, governing bodies are always watching. So, if your company doesn’t meet agreed-upon standards, you won’t fly under the radar for long. If the FDA finds elements of your processes that don’t measure up, they will first issue a Form 483. This is essentially a warning, saying you need to correct certain areas. For the past several years, the FDA has issued around five thousand of these forms annually.

After this form is administered, the FDA considers your company’s case and then determines what further action, if any, is appropriate to protect public health. This means that if you don’t reach compliance your company could be facing a hefty fine – or worse. Long story short, meeting CFR Part 11 compliance is important and necessary for companies using digital documentation.

An electronic signature, or an e-signature, is an electronic symbol, usually the person's name, that is attached to a form or contract and demonstrates consent. They are legally binding for all transactions they are used in. More simply put, an e-signature is just a signature that’s been attained digitally. According to the FDA, basic requirements for electronic signatures are as follows:

• • Each electronic signature must be unique to the individual and should not be reused or reassigned
  • The identity of the individual must be verified before establishing or sanctioning the individual’s electronic signature
  • Electronic signatures that are not based upon biometrics must employ at least two distinct identification components such as an identification code and password
  • No two individuals can have the same identification code and password combination
  • Identification code and password issuances must be periodically checked, recalled, or revised (e.g., to cover such events as password aging)
  • The system must use transaction safeguards to prevent unauthorized use of passwords and/or identification codes and to detect and report any attempts at their unauthorized use
  • A procedure must be in place for initial and periodic testing of devices that generate password information to ensure that they function properly

There are five major categories that Part 11 organizational requirements fall under. Here’s a breakdown of each of them: 

1. 1. 1. Validation: To ensure that all elements of your system work as intended, regular system software validation checks must be conducted, and their results should be recorded.
      2. Audit trail: Every creation, modification, or deletion of any record should be automatically stored in an audit history file. This documentation should be retained for a period and needs to be available for FDA auditors to review and copy if required.
      3. Operational controls: The documents and data your company manages need to follow a workflow structure. This means that your records are created, reviewed (if needed), and approved by specified personnel. Steps cannot be skipped over or worked around, and the entire process should be documented.
      4. Training: All users with access to your document management system should have thorough training and experience to currently perform their assigned tasks. This training must be documented and provable to an auditor.
      5. Electronic signatures: As one of the most common ways of reviewing and approving electronic records, electronic signatures show proof of your workflow process. To be compliant a digital signature must contain the printed name of the signer, the date and time when the signature was completed, and the meaning associated with the signature.

7. Can I purchase a compliant application or solution?

Yes, you can! There are plenty of software providers that deliver the functionality needed to help you become 21 CFR Part 11 compliant. Before deciding on a system, it’s important to do your research and ensure that their processes align with your compliance goals. 

8. How do I choose the right Document Control Software that is compliant with FDA 21 CFR Part 11?

The first and most important step in finding the right FDA-compliant Document Management Software (DMS) is to ask each vendor for a line-by-line FDA compliance matrix. This chart will show exactly how this software complies with the various subparts of 21 CFR Part 11, including their cloud environment. You’ll be able to examine each vendor’s regulatory fulfillment to make sure they’re the right fit for you before you waste time doing more research.

Any computer system that stores company data or is used to make decisions about quality must be compliant with 21 CFR Part 11. However, certain systems can make the compliance process easier than others. FDA guidance on software for electronic records and signatures is very broad, which gives different software providers the opportunity to tackle compliance in their own way. Therefore, certain vendors offer more benefits than just helping you avoid regulatory risks, such as better collaboration, smarter document control, or better data security. When looking at document control vendors, research not only how they can help you reach compliance, but also how they can benefit your overall business process.

To help make your DMS search easier, download our 6 Must-Ask Questions Before Choosing a DMS Provider guide here: 

To help your company navigate the compliance process, we’ve created a comprehensive 21 CFR Part 11 checklist. It includes each area of business the FDA inspects so you don’t miss a thing when preparing your processes. Check it out here: 21 CFR Part 11 Compliance Checklist

As professionals in regulated industries continue to shift away from traditional, paper-based solutions within their business, it’s imperative that they address rules and regulations outlined by FDA 21 CFR Part 11. Without this standard, effectively managing records and other content electronically becomes unpredictable, leading to a significantly increased risk of human error, operational costs, and time-to-market.

Check out our other resources on FDA 21 CFR Part 11 Compliance:

• 5 Tips for Improving the FDA Audit Process
• How to Address Electronic Signature Compliance
• How Version Control Software Helps You Stay FDA Compliant
• Abiding by FDA Regulations with Quality Management Software
• SaaS vs. PaaS: The Best Option for FDA Software Validation

With the help of ENSUR Document Control Management, you can easily prepare your electronic files to meet FDA standards, boost efficiency, and increase collaboration. To learn more, contact us today.