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iMedRIS Data Corporation’s response to
address the requirements of FDA 21 CFR Part 11 in Closed Systems |
Objective
This procedure describes how iMedRIS Data Corporation addresses the requirements of FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures) in Closed systems.
Policy/Procedure
Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records; Electronic Signatures came into effect on August 20, 1997 and sets forth criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. People using electronic signatures must certify to the agency that the electronic signature in their system is intended to be the legally binding equivalent of traditional handwritten signatures.
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Applicable Regulations and Guidelines How iMedRIS addresses the requirements of FDA 21 CFR Part 11 in Closed systems (iRIS21CFR11.pdf) |
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