| Document Type
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BL
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| Record Number
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841139
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| Main Entry
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López, Orlando
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| Title & Author
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Pharmaceutical and medical devices manufacturing computer systems validation /\ Orlando Lopez.
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| Publication Statement
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Boca Raton :: Taylor & Francis,, [2018]
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| Page. NO
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1 online resource
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| ISBN
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1315174618
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: 1351704346
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: 1351704354
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: 9781315174617
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: 9781351704342
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: 9781351704359
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9781138041189 (hardback : alk. paper)
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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What is computer systems validation (CSV)? -- CGMP regulatory requirements for production computer systems -- Maxims in CSV -- General CSV principles -- System lifecycle (SLC) -- SLC documentation (cover the data integrity in documentation) -- Management of the computer system requirements -- Risk management based validation -- CSV plans and schedules -- Project management, SLC and production computers validation -- Computer systems operational life -- Suppliers and service providers -- Trustworthy computer systems -- Control of data and record -- Technologies supporting integrity of electronic records -- Infrastructure qualification overview -- Remediation projects -- Production CSV program organization -- Alignment between system and data lifecycle updated -- Digital date and time stamps -- New technologies and critical processes (access management; big data; clouds environments; IoT; SLAs, wireless) -- All together.
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| Abstract
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Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement. Compliance is a state of being in accordance with established guidelines or specifications. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems are correctly achieved.
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| Subject
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Medical instruments and apparatus-- Design.
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Medical instruments and apparatus-- Quality control.
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Pharmaceutical industry-- Data processing.
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| Subject
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MEDICAL / Pharmacology
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Medical instruments and apparatus-- Design.
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Medical instruments and apparatus-- Quality control.
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Pharmaceutical industry-- Data processing.
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Computer Systems.
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Equipment and Supplies.
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Computer Security.
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| Subject
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Technology, Pharmaceutical-- methods.
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| Dewey Classification
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615.10285
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| LC Classification
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RS122.2
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| NLM classification
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W 26.55.C7
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