What is the Origin of 21 CFR Part 11?

This regulatory framework was formally established by the U.S. Food and Drug Administration (FDA) and is codified under Title 21 of the Code of Federal Regulations, becoming effective in August 1997. The regulation was developed to address the rapidly increasing use of electronic data management systems in the drug development and manufacturing industries. It provides the legal basis for utilizing digital data in regulatory submissions.

What is the Mechanism of 21 CFR Part 11?

The regulation mandates specific technical and procedural controls to ensure the security and integrity of electronic data, including system validation, audit trails, and access controls. These controls ensure that all electronic records related to the development and monitoring of hormonal therapies are accurate, complete, and protected from unauthorized modification. Compliance is critical for the reliable submission of clinical trial data and manufacturing quality documentation to the FDA.

21 CFR Part 11 ∞ Area

21 CFR Part 11

Meaning

21 CFR Part 11 is a regulation by the U.S. Food and Drug Administration (FDA) that establishes the requirements for electronic records and electronic signatures to be considered trustworthy, reliable, and legally equivalent to paper records and handwritten signatures. This rule is foundational for pharmaceutical and clinical research organizations operating in the hormonal health space. It ensures data integrity and authenticity within computerized systems used for regulated activities.