21 CFR 11 Compliance Statement

21 CFR Part 11 was established in August of 1997, which outlines the FDA’s requirements for electronic records and electronic signatures. These requirements are used to maintain the trustworthiness, reliability and integrity of electronic records. The rule contains two major sections: Electronic Records and Electronic Signatures. The following lists the sections, the requirements in italics and ASD’s interpretation and implementation of the requirement.


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