Transcription of GAMP Good Practice Guide: The Validation of Legacy Systems
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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?
GAMP Good Practice Guide 4 PHARMACEUTICAL ENGINEERING NOVEMBER/DECEMBER 2003 ©Copyright ISPE 2003 software, procedures, and reference manuals associated with the ...
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