This checklist allows for checking compliance with the validation, analysis and authentication requirements defined by 21 CFR 11, which governs the use of electronic records and signatures within the organization and defines the criteria by which their trustworthiness and equivalence to paper records is assessed.
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The information contained on this page and in the documents referred to is valid and current as of 07/17/23. Legislative and regulatory provisions are subjec to change and updating by the Regulatory Authorities. This being said, the writer declines all responsibility for any possible lack of topicality and/or accuracy of the information that may have occurred at the same time as or following the publication of this page and the documents referred to. Disclaimer