FDA 21 CFR Part 11 and EU GMP Annex 11 address similar concerns and aim to achieve the same goals, namely data integrity, comprehensive audit trails, limited system access, trained users, and more. However, there are notable differences between these regulations....
FDA 21 CFR Part 11, what is it? FDA 21 CFR Part 11 specifies the regulatory requirements used in Food and Drug Administration (FDA) regulated industries for electronic records and signatures. It outlines the requirements that companies must comply with to ensure the...
The 21 CFR Part 11 applicability assessment is useful in determining whether an electronic system must comply with the requirements of 21 CFR Part 11. By conducting the applicability assessment, Life Science companies can identify the specific 21 CFR Part 11 system...
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...
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