Part 11 Is Not Going Away: The New Electronic Records Draft Guidance

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BioPharm International, BioPharm International-05-01-2003, Volume 16, Issue 5

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.