Understanding Regulatory Requirements for 21 CFR Part 11 Compliance

In regulated industries such as pharmaceuticals, biotechnology, medical devices, and clinical research, compliance with 21 CFR Part 11 is critical to ensure that electronic records and signatures meet FDA standards. This set of regulatory requirements outlines the criteria for electronic records, signatures, and the systems used to manage them, ensuring that they are trustworthy, accurate, and secure. Organizations must adhere to these regulations to maintain data integrity and avoid potential penalties during inspections. This article provides an overview of the regulatory requirements under 21 CFR Part 11, highlighting the key areas that organizations must address to ensure compliance. What is 21 CFR Part 11? 21 CFR Part 11, established by the U.S. Food and Drug Administration (FDA), governs the use of electronic records and electronic signatures in FDA-regulated industries. The regulation applies to all records that are created, modified, maintained, archived, retrieved, or transmitted in electronic form. It ensures that electronic records have the same legal standing as paper records, provided they meet specific requirements for authenticity, security, and integrity.