21 Part 11

What is Part 11? 
The Code of Federal Regulations (CFR) provides the rules and regulations established by the Food and Drug Administration (FDA) for electronic records and electronic signatures, these are also referred to as 21 CFR Part 11 or Part 11 compliance. 21 CFR Part 11 describes the requirements to ensure trustworthiness, security, and reliability of the system and processes related to electronic records and signatures.   
 
What is the purpose of 21 CFR Part 11? 
The purpose of this regulatory requirement is to ensure the authenticity and integrity of the data. The requirements for Part 11 compliance require that the system meet specifications that allows for the electronic data to be audited. 
 
Which studies require Part 11 compliance? 
Studies that are FDA regulated are expected to follow FDA regulations and guidelines, including 21 CFR Part 11. Research is governed by FDA regulations when the research involves a human subject and an FDA-regulated test article, or human subjects research data will be submitted to or held for inspection by the FDA. A test article is meant to include any drug, biologic, medical device including in vitro diagnostics, food or food additive, and electronic products. The article may be FDA approved or investigational.  If you have questions about whether your study is FDA regulated (and hence requires 21 Part 11 compliance), please contact Compliance.
 
What documents are required to meet Part 11 compliance? 
All electronic study and regulatory documents including: signed consent forms, case report forms, source documentation, Delegation of Authority logs, and any other required document records per FDA regulation.  This includes documents and data stored in Florence or REDCap.