What Is FDA 21 CFR Part 11?

21 CFR Part 11 is part of a regulation by the FDA governing electronic

records and signatures.
It outlines requirements for ensuring the reliability, authenticity, and integrity
of electronic records and signatures used in FDA-regulated industries.
The initial publication of 21 CFR Part 11 occurred on March 20, 1997, and
has been in effect since August 20, 1997. The most recent change to the
regulation, as of July 2023, was made on March 2, 2023.

What Is the Main Purpose of

the FDA 21 CFR Part 11?
The main purpose of 21 CFR Part 11 is to ensure the trustworthiness and
reliability of electronic records and electronic signatures equivalent to
traditional paper records and handwritten signatures.
The 21 CFR Part 11 establishes requirements to ensure data integrity,
security, and reliability in electronic records and signatures to achieve its
aim.

What Are the Main Benefits of

21 CFR Part 11?
Implementing 21 CFR Part 11 provides several main benefits, which
include:
 Improved Data Integrity: The regulation ensures the accuracy,
completeness, and reliability of electronic records, reducing the risk of
errors and data inconsistencies.
 Regulatory Compliance: Following the requirements of 21 CFR Part 11
helps companies meet FDA regulations, demonstrating their commitment to
data integrity, security, and reliability.
 More Efficient Workflow Processes: Electronic records and signatures
enable streamlined and automated processes, reducing the reliance on
manual paperwork and improving efficiency.
 Streamlined Collaboration: Electronic systems facilitate data sharing
across teams, departments, and sites, enabling faster decision-making and
smoother workflows.
 Improved Auditability: The requirements for audit trails and electronic
signatures improve the auditability of electronic records, making it easier to
track and review actions taken.
 Increased Security: 21 CFR Part 11 outlines the implementation of robust
security measures, such as user authentication, access controls, and data
encryption, ensuring the confidentiality, integrity, and availability of
electronic records.
 Simplified Recordkeeping: Electronic recordkeeping eliminates the need
for physical storage space and reduces administrative burdens associated
with manual recordkeeping, allowing for more efficient and organized data
management.