What Are the Three Primary

Areas of 21 CFR Part 11?

The three primary areas of 21 CFR Part 11 are categorized into subparts A,
B, and C, which are as follows:
Subpart A – General Provisions: Define 21 CFR Part 11’s scope and
applicability and provide key definitions for terms used throughout the
regulation.
Subpart B – Electronic Records: Specify requirements for creating,
modifying, and maintaining electronic records. It includes controls and
procedures for ensuring data security, implementing audit trails, and
limiting system access.
Subpart C – Electronic Signatures: Specifically addresses the use of
electronic signatures. It outlines the requirements for their proper use,
including controls for identification codes and passwords.

What Are 21 CFR Part 11

Requirements?
21 CFR Part 11 requirements include the controls and procedures to
ensure the authenticity, integrity, and confidentiality of electronic records
and prevent the signer from easily denying the legitimacy of the signed
record.
In a brief overview, the 21 CFR Part 11 requirements are the following:
 21 CFR 11.1: Scope of regulation
 21 CFR 11.2: Implementation
 21 CFR 11.3: Definitions of terms
 21 CFR 11.10: Controls for closed systems
 21 CFR 11.30: Controls for open systems
 21 CFR 11.50: Signature manifestations
 21 CFR 11.70: Signature and record linking
 21 CFR 11.100: General electronic signatures requirements
 21 CFR 11.200: Electronic signature components and controls
 21 CFR 11.300: Controls for identification codes and passwords
You can learn more about the requirements outlined in the regulation in our
dedicated article about the 21 CFR Part 11 requirements.
 What Is an Electronic Record
Under 21 CFR Part 11?
An electronic record under 21 CFR Part 11 is any digital information
managed and processed electronically within the scope of 21 CFR Part 11.
It includes a combination of text, graphics, data, audio, pictorial, or other
information created, modified, maintained, archived, retrieved, or
distributed by a computer system as per 21 CFR 11.3(b)(6).
In addition to text documents, the following information assets are also
included:
 Images
 Sound files
 Videos
 Test records
 Source code
 Spreadsheets