Automation and Validation of Information in Pharmaceutical Processing: 90 (Drugs and the Pharmaceutical Sciences) - Tapa dura

THIS THOROUGHLY AUTHORITATIVE WORK FURNISHES ORGANIZATIONAL, TECHNOLOGICAL, VALIDATION, PROJECT MANAGEMENT, AND BUSINESS PERSPECTIVES ON PHARMACEUTICAL INFORMATION AUTOMATION FROM INDUSTRY AND SYSTEM AUTOMATION PROFESSIONALS-DEMONSTRATING HOW TO FULFILL COMPUTER SYSTEM VALIDATION REQUIREMENTS FOR HARDWARE, APPLICATIONS, NETWORKS, DATA CENTER OPERATIONS, AND COMPLEX SOFTWARE MANAGEMENT PRACTICES IN PHARMACEUTICAL MANUFACTURING. <BREXPLAINS HOW THE FOOD AND DRUG ADMINISTRATION'S LATEST GOOD MANUFACTURING PROCESS GUIDELINES SUPPORTING ELECTRONIC IDENTIFICATION AND ELECTRONIC SIGNATURES FOR BATCH RECORD REGISTRATION TOGETHER WITH COMPUTER SYSTEM TECHNOLOGIES WILL INFLUENCE PHARMACEUTICAL PRODUCTION AUTOMATION! <BRDESIGNED TO PROVIDE QUICK AND EASY ACCESS TO A WHOLE RANGE OF SYSTEM DEVELOPMENT TOPICS, AUTOMATION AND VALIDATION OF INFORMATION IN PHARMACEUTICAL PROCESSING<BR<LIDEFINES A COMPLETE LIFE-CYCLE METHODOLOGY THAT INTEGRATES EQUIPMENT, PEOPLE, AND INFORMATION <BR</LI<LIPRESENTS CONCEPTS, GUIDELINES, TEST PLANS, EXAMPLE FORMS, AND APPLICATION DETAILS FOR PREVIOUSLY UNAVAILABLE COMPUTER SYSTEM VALIDATION OF COMPLEX AUTOMATED INFORMATION SYSTEMS <BR</LI<LIINTRODUCES, FOR THE FIRST TIME IN DEPTH, PQ TESTING OF INTEGRATED MANUFACTURING EXECUTION (MES) AND MANUFACTURING RESOURCE PLANNING (MRP) APPLICATIONS <BR</LI<LIDESCRIBES HOW HUMAN RESOURCE PROGRAMS MAXIMIZE PRODUCTIVITY GAINS FOR AUTOMATION INITIATIVES <BR</LI<LIDISCUSSES APPROACHES TO AUTOMATING BATCH OPERATIONS WITH PROCESS CONTROL SYSTEMS USING INDUSTRY EXAMPLES AND APPLICABLE COMPUTER TECHNOLOGY CONCEPTS <BR</LI<LIPROVIDES AN OUTLINE FOR IQ, OQ, AND PQ TEST PLANS FOR PROCESS CONTROL SYSTEMS, INCLUDING FORMS FOR USE IN TESTING INSTRUMENTATION AND DISTRIBUTED CONTROL SYSTEM INSTALLATION AND OPERATIONS <BR</LI<LIEMPLOYS A BUSINESS ANALYSIS STANDPOINT ON LIFE-CYCLE PLANNING TO JUSTIFY NEW AUTOMATION PROJECTS, INCLUDING