By David Nettleton, Janet Gough
Masking the lately handed forty five CFR, and the parallel CFR 21 half eleven and HIPAA laws one hundred sixty, 162, and 164, this publication presents suggestions for buying, fitting, validating, and coping with advertisement off-the-shelf software program information for assortment and retention. Addressing the interface among those laws and the way to be in compliance with them, the authors hide audit trails, validation, documentation, education, and the way to set up and continue safety and responsibility. They speak about what the laws suggest by way of commonplace, clarify the audit functionality for amenities which are topic to the more recent HIPAA laws, and current the factors for documentation.
Read Online or Download Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 PDF
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Additional info for Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
Authentication the corroboration that a person is the one claimed. Availability the property that data or information is accessible and usable upon demand by an authorized person. Confidentiality the property that data or information is not made available or disclosed to unauthorized persons or processes. Encryption the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key. Facility the physical premises and the interior and exterior of a building(s).
E) Initial and periodic testing of devices, such When devices are used as electronic signature as tokens or cards, that bear or generate components, procedures must be in place to identification code or password information account for all devices and ensure their to ensure that they function properly and proper operation on a continual basis. have not been altered in an unauthorized manner. 316 45 CFR PARTS 160, 162 AND 164 AND INDUSTRY STANDARDS It takes time for industry standards to develop.
Regulations for submissions are separate from 21 CFR Part 11. Currently, each type of submission maintains a separate policy related to acceptance of electronic records. fm Page 24 Wednesday, November 19, 2003 9:41 AM Achieving and Maintaining Compliance 24 What the Regulations Say What the Regulations Mean Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records.