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Use of Electronic Records and Electronic Signatures

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-records-and-electronic-signatures-clinical-investigations-under-21-cfr-part-11
    This document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of...

Electronic Health Records | CMS

    https://www.cms.gov/Medicare/E-Health/EHealthRecords
    An Electronic Health Record (EHR) is an electronic version of a patients medical history, that is maintained by the provider over time, and may include all of …

Electronic Signature, Attestation, and Authorship.

    https://bok.ahima.org/doc?oid=107152
    An e-signature event captures and displays the e-signature, author’s name, credentials, date, and time of application. Once an entry has been electronically signed, the system …

eCFR :: 21 CFR Part 11 -- Electronic Records; Electronic …

    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
    (i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all …

Part 11, Electronic Records; Electronic Signatures

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

    Use of Electronic Records and Electronic Signatures …

      https://www.fda.gov/media/105557/download
      Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers . Guidance for …

    Digital Signatures in Healthcare: Are They …

      https://jacksonllp.com/digital-signatures/
      Electronic signatures (also called e-signatures) can include touch-sensitive screens where you use your finger or a stylus to sign your name as you would on a …

    Electronic Records and Signatures in Healthcare and the …

      https://corporate.findlaw.com/business-operations/electronic-records-and-signatures-in-healthcare-and-the-interplay.html
      Under E-SIGN, the term "electronic signature" means an electronic sound, symbol or process attached to or logically associated with a contract or other record and …

    ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES

      https://pharmaguidances.com/electronic-records/
      (a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer; (2) …

    Electronic signature for medical documents--integration …

      https://pubmed.ncbi.nlm.nih.gov/12425244/
      Application-independent hard and software components, in accordance with the signature law, must be integrated into electronic patient records, and provided to certification …



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