{"product_id":"automation-and-validation-of-information-joseph-f-despautz-9780824701192","title":"Automation and Validation of Information in Pharmaceutical Processing","description":"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. \u003cbr\u003eExplains 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! \u003cbr\u003eDesigned to provide quick and easy access to a whole range of system development topics, Automation and Validation of Information in Pharmaceutical Processing\u003cbr\u003e\u003cli\u003edefines a complete life-cycle methodology that integrates equipment, people, and information \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003epresents concepts, guidelines, test plans, example forms, and application details for previously unavailable computer system validation of complex automated information systems \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003eintroduces, for the first time in depth, PQ testing of integrated manufacturing execution (MES) and manufacturing resource planning (MRP) applications \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003edescribes how human resource programs maximize productivity gains for automation initiatives \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003ediscusses approaches to automating batch operations with process control systems using industry examples and applicable computer technology concepts \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003eprovides 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 \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003eemploys a business analysis standpoint on life-cycle planning to justify new automation projects, including multiyeardrug manufacturing plans \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003edocuments the successful application of life-cycle methodologies to supply chain functions \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003eand much more! \u003cbr\u003eTogether with references, tables, and drawings, Automation and Validation of Information in Pharmaceutical Processing is an essential, hands-on resource for pharmaceutical scientists, manufacturers, and engineers; drug quality assurance and regulatory personnel; project and program manufacturers; information system professionals and software developers and analysts; information technology practitioners; and graduate-level and continuing-education students in these disciplines.\u003c\/li\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Joseph F. Despautz\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0824701194\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780824701192\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 06\/16\/1998\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 464\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 3.05lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.16h x 6.24w x 1.06d","brand":"Joseph F. Despautz","offers":[{"title":"Hardcover","offer_id":48449000964351,"sku":"9780824701192","price":265.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_2677304d-d940-4bb8-87fe-92090632ff62.jpg?v=1777261509","url":"https:\/\/www.whiterainbookhouse.com\/products\/automation-and-validation-of-information-joseph-f-despautz-9780824701192","provider":"WR Book House","version":"1.0","type":"link"}