CFR Part 11 is a set of regulations issued by the U.S. Food and Drug Administration (FDA) that pertain to electronic records and electronic signatures. These regulations establish the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. The main purpose of these regulations is to ensure the integrity, confidentiality, and availability of electronic records and to protect against unauthorized access or alteration.
The regulations apply to all industries regulated by the FDA, such as pharmaceuticals, medical devices, biologics, and food, and to all electronic records and electronic signatures created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth by FDA regulations.
To be compliant with CFR Part 11, organizations must implement strict controls to ensure the authenticity, integrity, and confidentiality of electronic records, including implementing robust security protocols, implementing strict access controls, and maintaining audit trails. Organizations must also have procedures in place to ensure the authenticity and integrity of electronic signatures, including the use of secure digital signatures and role-based access controls. Violations of these regulations can result in penalties and fines, and non-compliance can also affect an organization’s ability to do business with the FDA and other regulatory agencies.
CFR Part 11 also requires organizations to have procedures in place for the identification and documentation of electronic records, including procedures for verifying that electronic records accurately reflect the original paper records, and procedures for ensuring that electronic records are legible, readily accessible, and easily readable.
Violations of CFR Part 11 can result in penalties and fines, and non-compliance can also affect an organization’s ability to do business with the FDA and other regulatory agencies. As such, it is important for organizations to understand and comply with these regulations in order to protect their reputation, maintain the integrity and confidentiality of their records, and ensure the safety and efficacy of their products.
