Title 21 CFR Part 11: An Overview

Introduction

CFR Chapter 21 Part 11 is a set of regulations issued by the U.S. Food and Drug Administration (FDA) that governs the use of electronic records and electronic signatures in the pharmaceutical, biotechnology, medical device, and other FDA-regulated industries. The purpose of Part 11 is to ensure the reliability, integrity, and security of electronic data and to prevent fraud, tampering, and human error. Part 11 applies to any electronic records or signatures that are created, modified, maintained, archived, retrieved, or transmitted under any FDA requirements.

Scope and Applicability

Part 11 covers two types of electronic systems: closed systems and open systems. A closed system is one in which the electronic records are accessible only to authorized persons within the same organization. An open system is one in which the electronic records are accessible to persons outside the organization, such as customers, suppliers, or regulators. Part 11 requires that both types of systems have adequate controls to ensure the authenticity, confidentiality, and integrity of electronic records and signatures.

Part 11 applies to any electronic records or signatures that are required by the FDA or that are used to demonstrate compliance with FDA regulations. Examples of such records include clinical trial data, laboratory results, manufacturing records, quality control records, adverse event reports, and product labeling. Part 11 does not apply to paper records that are printed from electronic records, unless they are used as official records in lieu of the electronic records. Part 11 also does not apply to electronic records that are not required by the FDA or that are not used to demonstrate compliance with FDA regulations, unless they are explicitly identified by the FDA as subject to Part 11.

Requirements and Implementation

Part 11 consists of three main sections: general provisions, electronic records, and electronic signatures. The general provisions section defines the terms and scope of Part 11 and outlines the responsibilities of the FDA and the regulated entities. The electronic records section specifies the criteria and procedures for creating, maintaining, and protecting electronic records. The electronic signatures section specifies the criteria and procedures for creating, verifying, and using electronic signatures.

Some of the key requirements of Part 11 include:

• Electronic records and signatures must be equivalent to paper records and handwritten signatures in terms of legal validity and enforceability.
• Electronic records and signatures must be accurate, complete, consistent, and trustworthy.
• Electronic records and signatures must be protected from unauthorized access, alteration, deletion, or loss.
• Electronic records and signatures must be auditable and traceable to the person who created, modified, or approved them.
• Electronic records and signatures must be compatible with the FDA's ability to inspect, review, and copy them.
• Electronic systems must have adequate security measures, such as passwords, encryption, firewalls, and antivirus software.
• Electronic systems must have adequate validation, testing, and documentation to ensure their functionality and reliability.
• Electronic systems must have adequate backup and recovery procedures to prevent data loss or corruption.
• Electronic systems must have adequate policies and procedures to govern their operation, maintenance, and change control.
• Electronic systems must have adequate training and education programs for the users and administrators.

The FDA does not prescribe specific methods or technologies for implementing Part 11 requirements. Instead, the FDA allows the regulated entities to use a risk-based approach to determine the appropriate level and type of controls for their electronic systems, based on the nature, complexity, and importance of the data and processes involved. The FDA also recognizes that the technology and best practices for electronic systems evolve over time, and therefore encourages the regulated entities to adopt the most current and effective solutions for their electronic systems, as long as they comply with the principles and objectives of Part 11.

Conclusion

CFR Chapter 21 Part 11 is a vital regulation that ensures the quality, safety, and efficacy of the products and services regulated by the FDA. By complying with Part 11, the regulated entities can benefit from the advantages of electronic systems, such as increased efficiency, accuracy, and accessibility, while minimizing the risks of data integrity, security, and fraud. Part 11 also facilitates the communication and collaboration between the regulated entities and the FDA, as well as other stakeholders, such as customers, suppliers, and auditors.