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What Is 21 CFR Part 11?

21 CFR is a title within the Code of Federal Regulations. Title 21 is reserved for the rules of the United States Food and Drug Administration (FDA). Part 11, specifically, deals with the comparisons between electronic and paper records, and how to ensure that electronic files are kept secure and relevant to be used in conducting the nation's business. Part 11 is divided into three subsections. The first, Subpart A, covers general information for readers such as scope and applicability of the regulation. The second subsection, Subpart B, addresses requirements for electronic records systems. And finally, the third subsection, Subpart C, addresses electronic signatures and how they are stored and processed.

Requirements for Electronic Records

Electronic records are more convenient and cost-effective when properly stored, protected and handled. Electronic records may be stored on closed systems or open systems. In Subpart B of Part 11, users will find the requirements for the setup, storage and use of electronic systems of records on both closed and open systems. These requirements include validation of records and records keeping systems. The owner and maintainer of a records system must also ensure that only authorized users access these systems. Protection of files and the requirement for written policies governing the system of records and users are also addressed in this subsection. The subsection also covers a requirement that records must be easily retrievable, printable and usable for those parties with a valid need for the information.

Requirements for Electronic Signatures

Electronic signatures allow documents to be signed without the need to print, sign in wet ink and scan back into a system of records. This cuts down on approval time and cost for materials and supplies. However, signatures must be properly validated and utilized. Subpart C of Part 11 addresses the requirements for these electronic signatures. Electronic signatures must contain several pieces of information. The name of the person signing the document, as well as the date and time the document was signed must be recorded in the signature. In addition, the disposition associated with the signature must be recorded; some dispositions include approval, denial, review or creation of a document. Only authorized individuals may sign documents, and the owner of the system of records is responsible for the documents and the signatures on them. Signed documents must be easily accessible to those with a valid need to use them. Electronically signed documents must also be stored securely so there is no risk of corruption of the signature or the data contained within.

The Code of Federal Regulations is very user-friendly and easy to understand. For more information, or to read these regulations in their entirety, users can visit the FDA's website online. The text of 21 CFR Part 11 is located within this site. The regulations are easily organized with clickable links, and allow users to print or bookmark sections for later use.

Understanding 21 CFR Part 11 Webinar February 19, 2014

Join us for our "Understanding 21 CFR Part 11″ webinar on February 19th, 2014, when we will discuss in greater detail 21 CFR Part 11, and what you need to know the most.