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Title: Application Of Electronic Records & Signatures In Calibration Management Software
Author: Jim Erickson
Source: 2001 Measurement Science Conference
Year Published: 2001
Abstract: Effective August 20, 1997, the Food and Drug Administration (FDA) issued 21 CFR Part 11, setting forth criteria under which the agency will accept, under certain circumstances, electronic records and electronic signatures as equivalent to paper records and handwritten signatures. Part 11 allows firms to take advantage of electronic technology, and to have electronic records considered equivalent to traditional paper records. Such systems will need to be validated to ensure accuracy, reliability, and consistency, and they will need security checks and audit trails to verify that records are accurate and that changes are recorded. Electronic signatures are subject to additional requirements, to ensure that a signature can only be used by its genuine owner, and that the act of signing a document electronically is equivalent to a traditional handwritten signature.

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