Pharmaceutical and medical devices manufacturing computer systems validation:

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 an...

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Bibliographische Detailangaben
1. Verfasser: López, Orlando (VerfasserIn)
Format: Elektronisch E-Book
Sprache:English
Veröffentlicht: Boca Raton Taylor & Francis [2018]
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Online-Zugang:Volltext
Zusammenfassung: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
Beschreibung:Description based on print version record and CIP data provided by publisher
Beschreibung:1 online resource
ISBN:9781351704342
1351704346
9781315174617
1315174618
9781351704359
1351704354

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