The 21 CFR Part 11 is part of US Food and Drug Administration (FDA) regulations specifying electronic record requirements. Among these records are the training records. It is important to properly manage training records to demonstrate that employees have completed...
21 CFR Part 11 compliant electronic records represent the digital records that comply with the Food and Drug Administration (FDA) 21 CFR Part 11 regulation requirements. The regulation aims to ensure the authenticity, integrity, and, when appropriate, confidentiality...
The 21 CFR Part 11 compliance checklist is a tool that can be used to evaluate the level of compliance with the requirements outlined in 21 CFR Part 11. It provides a comprehensive list of questions to consider when assessing the compliance of electronic records and...
The FDA 21 CFR Part 11 was established by the US Food and Drug Administration (FDA) to ensure the authenticity, integrity, and confidentiality of electronic records and electronic signatures. This part of the regulation governs how electronic records and signatures...
Companies subject to 21 CFR Part 11 must adhere to strict requirements for electronic records, electronic signatures, and computer systems to comply with the FDA regulations. To help companies stay on top of regulatory compliance, we have examined official FDA data,...
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