FDA 21 CFR Part 11 Compliance: A Concise Look at Regulation

Cynthia Weber, December 8, 2023

21 CFR Part 11 details specific regulations for the use of electronic signatures, records, and handwritten signatures that are captured for electronic records. It outlines how these electronic signatures and records are considered “equivalent to paper records and handwritten signatures executed on paper.”

An important clause specifies that electronic records are not confined to documents – they can also be entries in a database like electronic case report forms (eCRFs). As these signatures are applied electronically to an electronic record, they must satisfy certain criteria to comply with Part 11 requirements.

What Does 21 CFR Part 11 Cover?

Part 11 of the code pertains to electronic records that are generated, altered, preserved, archived, accessed, transmitted, or submitted, in accordance with any record-keeping requirements established by the U.S. Food and Drug Administration (FDA). Part 11 is broken down into 3 subparts:

Section A — Basic Provisions

This section details the extent and relevance of 21 CFR Part 11, along with the explanation of crucial terms used throughout the regulations. It offers a summary of the obligations that businesses employing electronic records and signatures need to fulfill to adhere to these regulations.

Section B — Digital Records

This section sets the standards for the generation, alteration, and preservation of digital records, including protocols for data protection, audit trails, and digital signatures. This outlines the necessary controls for both closed and open systems, along with the essential signature displays and connections.

Section C — Digital Signatures

This section directs the application of digital signatures, including the prerequisites for their usage and how to manage identification codes and passwords. It specifies the requirements for electronic signature components and controls.

Which Industries are Required to Comply?

Part 11 applies to all FDA-regulated industries including drug, medical device, and food & beverage. As of the introduction of MoCRA, the cosmetic industry is also now expected to follow the regulations outlined in the CFR.

Part 11 requires these businesses implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for all software and systems involved in processing electronic data that FDA requires.

How to Easily Achieve Compliance with 21 CFR Part 11.

Registrar Corp is the global leader in FDA compliance, serving over 30,000 companies each year in over 175 countries with tech-enabled compliance services, online compliance training, and innovative software solutions.

We know what it takes to achieve and maintain compliance with FDA’s regulations regarding electronic records and signatures. That’s why our industry professionals have created an Introduction to 21 CFR 11 course that allows you to dive into specific requirements, including:

  • Validation of computerized systems
  • Requirements for computer generated signatures
  • Time-stamped audit trails
  • Requirements for legacy systems

Discover how CFR Title 21, Part 11 affects your business. Gain the essential skills to navigate the FDA’s electronic record and signature regulations with our latest online course.