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The user guide engraved into a model of the Antikythera Mechanism. User guides have been found with ancient devices. One example is the Antikythera Mechanism, [1] a 2,000 year old Greek analogue computer that was found off the coast of the Greek island Antikythera in the year 1900.
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The agency has a computer application called the Compliance Management System (CMS, or MARC-CMS) that district offices use to electronically submit warning letter recommendations to FDA Centers. All district office must use the CMS to submit the warning letter recommendation, the Form FDA 483 that supports the alleged violations, the ...
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A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. [4] However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 [ 5 ] The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the ...