Application of Electronic Records & Signatures in Calibration Management Software

Topics:
Electrical and Electronic,
Pharmeceuticals,
Specifications and Control
Tags:
Electronic Record,
Federal Government,
Government,
Signature,
Software
Source:
Blue Mountain Quality Resources

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Overview: 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. 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. The paper depicts that Calibration Management Software (CMS) is database software designed specifically to help companies meet the calibration record-keeping requirements of 21 CFR Parts 211 and 820.

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Format: PDF | Size: 60KB | Date: Jun 2005 | Pages: 4

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