FDA 21 CFR Part 11 compliance checklist

What is FDA 21 CFR Part 11?

FDA 21 CFR—sometimes known as Title 21—is a set of regulations that control the efficacy, safety, and labeling of medical devices, food, and drugs. Altogether, there are 21 parts that cover different topics. FDA 21 CFR Part 11 provides guidelines for electronic records and signatures. The FDA created Part 11 in 1997 to help ease the transition to digital electronic records and signatures within its regulated industries. Today, the regulation remains a critical framework for all FDA-regulated companies using electronic systems.

Why is FDA 21 CFR Part 11 important?

FDA 21 CFR Part 11 helps ensure that all electronic devices that require regulation are safe, reliable, and in compliance with FDA regulations. It protects consumers from harmful data malpractice while also making it easier for companies to store digital records and signatures.

Part 11 compliance is mandatory for FDA-regulated companies. If your business fails to adhere to Part 11 guidelines, it could face consequences like warning letters, regulatory penalties, fines, and legal actions. Noncompliance could also create negative publicity, leading to reputational harm and financial loss. Complying with Part 11 also improves data integrity by helping prevent unauthorized data access and data tampering. Companies can use Part 11 guidelines to strengthen privacy and security and ensure all records remain accurate and consistent.

The FDA requires regulated companies to align with its good manufacturing practices (GMP). Following Part 11 guidelines supports GMP efforts by demonstrating sound electronic recordkeeping and management and ensuring strong data management.

If your business fails to adhere to Part 11 guidelines, it could face consequences like warning letters, regulatory penalties, fines, and legal actions. Noncompliance could also create negative publicity, leading to reputational harm and financial loss.

What are the requirements of FDA 21 CFR Part 11?

According to the FDA, Part 11 applies to all electronic signatures and records that companies create, modify, maintain, archive, retrieve, or transmit. In addition, Part 11 applies to electronic records that organizations submit to the agency under the Federal Food, Drug, and Cosmetic Act (FD&C) and the Public Health Service Act (PHS).

• Electronic records management. Electronic records need to be accurate, reliable, and trustworthy, as well as in alignment with paper records. Companies must preserve their content and context throughout their lifecycle.
• Electronic signatures. Electronic signatures must be unique to be valid. In addition, signatures must be verifiable and link to a corresponding electronic record.
• Validation. The computer systems that you use to create, maintain, or modify electronic records must be properly installed and configured in accordance with Part 11 specifications.
• Audit trails. All user actions regarding electronic records must contain secure, computer-generated audit trails. The trails must identify the person making the action, the time and date, and the specific change taking place.
• Records retention. Records must be on file and available for inspection and review throughout their retention period. Part 11 also allows organizations to archive records to non-electronic media like microfilm, microfiche, or paper to a standard electronic file format.

How do I comply with FDA 21 CFR Part 11?

Achieving Part 11 compliance isn’t a one-time process. If your business stores electronic records and signatures, it needs to adopt best practices and routinely audit and inspect its processes to make sure they align with the FDA’s expectations.

Keep in mind that while Part 11 is several decades old, the FDA continues to evolve its thinking regarding the policy and its application to electronic records, systems, and signatures. For further guidance, a recent FDA webinar focuses on their evolving uses in clinical investigations.

It’s also important to work with legal advisors, product managers, and other internal stakeholders when planning for Part 11 compliance. As you go through the process, use the following checklists to smooth the road to compliance.

Electronic signatures

To achieve compliance, you’ll need to have measures in place that ensure the integrity and reliability of your electronic signatures.

• Outline specific requirements for electronic signatures.
• Use controls to ensure electronic signatures correlate with electronic records.
• Install mechanisms to ensure the integrity of your electronic signatures.

Electronic records management

When storing electronic records, take active measures to ensure documents remain secure and accessible throughout their entire lifecycle.

• Create policies and procedures for managing electronic records.
• Set strong access controls to prevent unauthorized users from modifying records.
• Maintain computer-generated audit trails at all times.

Computer system validation

The computer system that you use to manage and store electronic records and signatures must be fully optimized and contain thorough compliance documentation.

• Determine the regulatory requirements for your specific computer system.
• Work with reputable vendors offering Part 11-compliant services. Vendors must be able to provide documentation and demonstrate compliance.
• Create a system change control process to manage changes to your computer system.

Security measures and access control

Electronic records should contain robust security features and strong access controls to prevent tampering.

• Set comprehensive access control policies to determine who can access records.
• Create processes for user account creation and modification.
• Use encryption mechanisms to protect data at rest and in transit.

Periodic review and system maintenance

It’s critical to periodically review and maintain your electronic records and management systems to evaluate their compliance with Part 11.

• Review your processes, controls, and documentation to ensure they align with the FDA’s requirements.
• Check for data integrity to verify the accuracy of your electronic records.
• Monitor your electronic records and review audit trails to identify security incidents or changes.

Documentation and recordkeeping

Thorough recordkeeping is necessary to ensure that electronic records remain traceable and accessible.

• Use a document management system to create, modify, and archive electronic records.
• Create policies to manage electronic document retention.
• Develop procedures that outline specific processes for managing electronic records.

Preparing for audits and inspections

Companies must be prepared to respond to FDA requests for Part 11 audits and inspections.

• Review the regulation with your legal team to ensure you understand what your business needs in order to achieve compliance.
• Create thorough documentation and verify that it aligns with the FDA’s standards.
• Perform regular internal audits to identify vulnerabilities and address areas that need improvement.

Streamline FDA 21 CFR Part 11 compliance with Tricentis

Achieving Part 11 compliance is a complex and challenging process. Attempting to piece together a compliance strategy is time-consuming, risky, and may lead to accidental violations. Consider partnering with a provider that can make Part 11 compliance a breeze.

For example, Tricentis Vera™ offers a one-stop shop purpose-built for digital validation. With Vera, your business can achieve compliance with Part 11 and related regulations while expediting reviews and approvals. To experience Vera in action, request a demo today.

This post was written by Justin Reynolds. Justin is a freelance writer who enjoys telling stories about how technology, science, and creativity can help workers be more productive. In his spare time, he likes seeing or playing live music, hiking, and traveling.