What is the main focus of 21 CFR Part 11?

The main focus of 21 CFR Part 11 is data integrity, specifically relating to electronic records and electronic signatures in the context of regulated environments, such as clinical trials. This regulation sets the standards for ensuring that electronic records are trustworthy, reliable, and equivalent to traditional paper records.

While electronic submission requests can fall under the purview of 21 CFR Part 11 due to the requirement for compliance with data integrity standards, the core intent of the regulation is to ensure that all electronic records maintain the same level of reliability and accountability as physical records. This includes aspects such as audit trails, security controls, and ensuring that electronic signatures are valid and can be linked to their respective records.

Understanding the proper application of 21 CFR Part 11 is crucial for anyone involved in clinical trials, as it directly impacts how data is managed and validated electronically, ensuring compliance with regulatory standards.