1、 PLM Oracle 2008 1 PLM 3 3 .4 PLM 7 .8 .9 .10 .10 .11 .11 .11 .12 12 (PLM) Oracle PLM PLM Oracle PLM Oracle Agile R&D Agile 1 Agile 8 10 15 2 15 PhRMA Tuffs 1995 3 R&D Oracle PLM PLM Agile PLM 270 PLM Agile ( ) Agile 1 2 3 4 5 (CMO) (CPO) (Good Manufacturing Practice) 6 (SOP) (QA) (CAPA) 7 UK-92480
2、(Viagra) (U.S. Hatch-Waxman Act) FDA 5 350 CRO Agile Agile R&D MBR(master batch record) MBR Microsoft Word Adobe PDF Agile MBR MBR SOP MBR Oracle Agile 4 ( Survey Reflects Growing Maturity of CMC Outsourcing PharmTech 2002 8 ) PDX(Product Definition eXchange) (CRO) CMP CPO PDX PDX (XML) (CFR) 21 11
3、PDX www.pdxstandard.org 75% 30%40% Agile Agile ( ) Agile (CAPA) Agile CAPA CAPA Agile R&D Agile Agile (CFR) 21 11 21 11 Agile 11 Oracle (U.S. Data Management) FDA Agile FDA ( CFR 21 11 ) Agile FDA Oracle FDA FDA Oracle Oracle FDA Oracle Oracle Agile (Agile Food and Drug Administration Validation Pac
4、k) FDA Agile PLM Agile Agile Agile AMR PLM Kevin O Marah Oracle Agile Product Lifecycle Management in the Pharmaceutical Industry Updated January 2008 Oracle Corporation World Headquarters 500 Oracle Parkway Redwood Shores, CA 94065 U.S.A. Worldwide Inquiries: Phone: +1.650.506.7000 Fax: +1.650.506.
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