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FDA 21 CFR Part 11: validation record
21 CFR 11 GMP
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Design Qualification Installation Qualification Operation Qualification Performance Qualification
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Responsibilities of Vendors/Users "It is the responsibility of the user to ensure that the software program has been validated" "It is acceptable for formal validation of software to be carried out by the supplier on behalf of the user, provided that the user undertakes a formal acceptance test" OECD OECD GLP Principles, Monograph 49 The responsibility for demonstrating that systems have been validated lies with the user" "Without prior written assurance from the vendor, the laboratory should not automatically assume that the vendor supplied software has been properly validated" FDA Tetzlaff, FDA Inspector, Pharm.Technol., May 1992, 71/82 sa OECD=Organization of Economic Cooperation and Development FDA = Food and Drug Administration Choose View, Header and Footer to enter text here
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GLP/GMP FDA 21CFR Part 11 Implentation on Agilent ChemStation Plus (21CFR Part 11)
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