Impact of USP <1058> - Regulatory Spotlight on Analytical Instrument Qualification (AIQ)

Regulatory 101 What is AIQ ? Complete DQ/IQ Paul Smith Global Strategic Compliance Program Manager Agilent Technologies, Inc. July 9, 2015 Confidentiality Label July 10, 2015 1 10 Steps to a “New Instrument”…. User Requirement Specification URS 1. • •…

[ ARTICLE ] Analytical Instrument Qualification with Data Integrity in Mind Heather Longden, Senior Marketing Manager, Pharmaceutical Regulatory Compliance Waters Corporation, Milford, MA, USA It is critical to understand the data integrity implications regarding analytical instrument qualification. OVERVIEW Analytical Instrument…

Agilent Equipment Qualification Solutions Qualify the Instruments in Your Laboratory with a Harmonized, and Data Integrity Compliant Solution Instrument Qualification – A Regulatory Requirement For your analytical results to be valid, your analytical instruments must be suitable for their intended…

[ ARTICLE ] Analytical Instrument Qualification with Data Integrity in Mind Heather Longden, Senior Marketing Manager, Pharmaceutical Regulatory Compliance Waters Corporation, Milford, MA, USA It is critical to understand the data integrity implications regarding analytical instrument qualification. OVERVIEW Analytical Instrument…