What is 21 CFR Part 11?

This post is part of 'Domain | General' series


Code of Federal Regulations (CFR)

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles, each representing an area of federal regulation, such as agriculture, energy, or transportation. Each title is further subdivided into chapters, parts, sections, and paragraphs, and is updated annually through a process of publication in the Federal Register. The CFR contains a compilation of rules and regulations that affect a wide range of topics, including but not limited to, health care, food and drug safety, aviation, environmental protection, and national security.

21 CFR

"21 CFR" refers to the Code of Federal Regulations Title 21, which contains the regulations of the Food and Drug Administration (FDA) of the United States Department of Health and Human Services (HHS).

Title 21 covers a broad range of topics related to food and drugs, including regulations related to the manufacturing, processing, packaging, labeling, and distribution of drugs and medical devices. These regulations are designed to ensure the safety, effectiveness, and quality of products regulated by the FDA.

In the context of clinical trials, 21 CFR includes regulations related to the conduct of clinical trials, including requirements for informed consent, institutional review boards (IRBs), and the collection and management of clinical trial data. These regulations are important for ensuring the ethical conduct of clinical trials and the accuracy and reliability of the data generated by these trials.

21 CFR Part 11

21 CFR Part 11 is a regulation issued by the US Food and Drug Administration (FDA) that sets out the criteria for electronic records and electronic signatures used in clinical trials and other regulated activities. It applies to electronic records created, modified, maintained, archived, retrieved, or transmitted by a regulated entity in the course of a clinical trial or other FDA-regulated activity.

Part 11 was introduced in response to concerns about the reliability, authenticity, and integrity of electronic records and signatures used in regulated activities. The regulation sets out specific requirements for the use of electronic records and signatures to ensure that they are trustworthy, reliable, and equivalent to paper records and handwritten signatures.

Some of the key requirements of 21 CFR Part 11 include:

  • Validation: Electronic systems used in clinical trials must be validated to ensure that they are reliable, consistent, and accurate.
  • Access controls: Access to electronic records must be limited to authorized personnel, and the system must have safeguards in place to prevent unauthorized access.
  • Audit trails: Electronic systems must have an audit trail that records all changes and modifications to electronic records.
  • Electronic signatures: Electronic signatures must be unique to the individual, contain identifying information, and be linked to the specific electronic record.
  • Record retention: Electronic records must be retained for the same period as paper records.

Compliance with 21 CFR Part 11 is important in clinical trials because it ensures that electronic records and signatures are trustworthy and can be used as evidence of compliance with regulatory requirements. Non-compliance with Part 11 can result in regulatory action by the FDA, including fines, product recalls, or delays in the approval of clinical trials or marketing applications.


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