Part 11 Is Not Going Away: The New Electronic Records Draft Guidance

Winter,Woflgang;Ludwig Huber;

Publication

Article

May 15, 2003

BioPharm International

BioPharm International-05-01-2003

Volume16

Issue 5

Part 11 Is Not Going Away: The New Electronic Records Draft Guidance

Author(s):

Wolfgang Winter,Ludwig Huber

by Wolfgang Winter, Agilent Technologies GmbH and Ludwig Huber, Agilent Technologies GmbH The rules for electronic records and signatures still remain in effect. The change means that companies must now justify their decisions on whether or not to implement specific electronic controls with documented risk assessments and considerations of the record requirements detailed in the corresponding predicate rule.

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Part 11 Is Not Going Away: The New Electronic Records Draft Guidance

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