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21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.

21 CFR Part 11 is the FDA's regulation for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company's quality management system and gives guidance for industry best practices.

As e-signature solutions are highly secure and time-efficient and provide non-repudiation of data, It assists HIM (Health Information Management) workers by lowering the cost and cycle time of delivering necessary information as well as minimizing the danger of illegal access to these electronically executed documents.

Ing to the definition established in the US Federal ESIGN Act, it is ?an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record.? Essentially, an electronic signature is a person's agreement ...

What should be documented The most current information. ... Clinically pertinent information. ... Rationale for decisions. ... Informed Consent discussions or the patient's refusal of care. ... Discharge instructions. ... Follow-up plans. ... Patient complaints and response. ... Clinically pertinent telephone calls.

Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) and ONDCP (Office of National Drug Control Policy).

21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.