E__04 Tech_Info_HPLC validation_计算机化的Liquid Chromagraphi.pdf

Liquid Chromagraphic Systems Page 1 of 10 FDA Logo of and Link to start page of Office of HHS Logo Logo--lin Regulatory Affairs, U.S. Food and Drug and link to FDA Administration to home Department FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search Validation of Computerized Liquid Chromatographic Systems   William B. Furman and Thomas P. Layloff U.S. Food and Drug Administration Division of Drug Analysis 1114 Market Street, Room 1002 St. Louis, MO 63101 Ronald F. Tetzlaff U.S. Food and Drug Administration 60 Eighth Street, NE Atlanta, GA 30309 _________________________________________________________________ Received July 28, 1993. Accepted by GL August 31, 1993. Presented in part at the Workshop on Antibiotics and Drugs in Feeds, 106th AOAC Annual International Meeting and Exposition, August 30, 1992, at Cincinnati, OH. Introduction Almost all vendors of liquid chromatographs offer dedicated computer-based controller/data-processing systems. These systems are integrated into the operation of the equipment and frequently use proprietary software systems for which complete documentation and program listings are not available to the user. In some i