Get 21 Cfr Part 11 Download

Displaying title 21, up to date as of 4/03/2023. Title 21 was last amended 3/30/2023. Navigate by entering citations or phrases (eg: 1 CFR 1.1 49 CFR 172.101 Organization and Purpose 1/1.1 Regulation Y FAR).

The FDA has stringent regulations that apply to life science companies, particularly when it comes to electronic records and signatures. One essential part of complying with those regulations is filing a 21 CFR Part 11 letter of certification, better known as a letter of non-repudiation agreement.

Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).

7 critical requirements for 21 CFR Part 11 Data integrity. ... Data retrieval. ... Validation. ... Audit Trails. ... Operational Controls. ... Security Controls. ... Electronic signatures.

21 CFR Part 11-compliant software is any document management software that meets the U.S. FDA's requirements for the acceptance of electronic records and electronic signatures.

Part 11 requires you to have a complete version history available for every quality document in your system, through the: “Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.”