Medical software 21 CFR Part 11

managementsecurityvalidation

21 CFR Part 11 is a regulation issued by the United States Food and Drug Administration (FDA) that establishes criteria for electronic records and electronic signatures. It applies to companies that create, modify, maintain, or transmit electronic records related to drug or device manufacturing, testing, and distribution. 21 CFR Part 11 compliant software refers to software systems that meet the criteria set forth in the regulation. These criteria include requirements for: Security: the software must have controls in place to ensure the confidentiality, integrity, and availability of electronic records. Audit trails: the software must be able to record and retain information about every change made to an electronic record, including who made the change and when. Electronic signatures: the software must have controls in place to ensure that electronic signatures are unique, cannot be transferred, and are linked to the individual signing the record. Validation: the software must be validated to ensure that it functions as intended and meets the requirements of the regulation. 21 CFR Part 11 compliant software is important for companies that operate in regulated industries to ensure compliance with FDA regulations and to maintain the safety and efficacy of their products. Software vendors that offer 21 CFR Part 11 compliant software typically provide documentation and support to help their customers meet the regulation’s requirements.