Transcription of GAMP Good Practice Guide: The Validation of …
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Legacy SystemsNOVEMBER/DECEMBER 2003 PHARMACEUTICAL ENGINEERING1 Copyright ISPE 2003 GAMP good Practice Guide: The Validation of Legacy SystemsThis Guidediscusses theconsiderationswhich shouldexplain thisactivity andsuggests aprocess to befollowed inorder to assessand view of the rapid evolution of both newtechnologies and regulatory expectations overrecent years, it is crucial that pharmaceuticalorganizations take positive action to maintaintheir existing cGxP-related systems in a vali-dated state. This guide discusses the consider-ations which should explain this activity andsuggests a process to be followed in order toassess and validate Legacy is a Legacy System?There is no formally accepted definition of Legacy System, but for the purposes of thisGAMP good Practice guide (GPG), a LegacySystem should be considered to be any GxPrelevant system that is in place and in use, andwhich is deemed not to satisfy current regula-tory is not acceptable under any circumstanceto implement a new system that has not beenv
GAMP Good Practice Guide 4 PHARMACEUTICAL ENGINEERING NOVEMBER/DECEMBER 2003 ©Copyright ISPE 2003 software, procedures, and reference manuals associated with the Legacy System
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