Analytical Instrument Qualification with Data Integrity in Mind

[ 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…

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. • •…

White paper System Suitability Tests and AIQ R.D.McDowall PhD Principal, McDowall Consulting Paul Smith European Validation Program Manager, PerkinElmer Nicola Vosloo PhD European Market Development Leader, PerkinElmer Why System Suitability Tests Are Not a Substitute for Analytical Instrument Qualification Purpose…

Impact of USP <1058> Regulatory Spotlight on Analytical Instrument Qualification (AIQ) Technical Overview Introduction The 2017 version of USP general chapter <1058> on analytical instrument qualification (AIQ) became effective on August 1, 20171. This is the first update to this…