Validating Automated Manufacturing and Laboratory Applications: Putting Principles into Practice - Hardcover

Wingate, Guy

 
9781574910377: Validating Automated Manufacturing and Laboratory Applications: Putting Principles into Practice
Hardcover
ISBN 10: 157491037X ISBN 13: 9781574910377
Verlag: CRC Press Inc, 1997

Inhaltsangabe

Since 1994, the German GMA-NAMUR, German APV, ISPE-Baseline, OECD, UK GAMP Forum, UK IQA-PQG, US DIA, ISPE, and PDA initiatives have supplemented the regulations governing the validation of automated systems with high-level guidelines. The result has been a broadly accepted industry framework for validating automation systems. It includes Good Automated Manufacturing Practice (GAMP), Good Automated Laboratory Practice (GALP), and Good Information Technology Practice (GITP). This book deals directly with project problems and their resolutions based upon the experience of established industry practitioners. The first part introduces the principles of good practice and why validation is needed, concluding with the Ten Commandments for Validating Automation. The second part presents a comprehensive selection of case studies (provided by industry experts).

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Verlag
CRC Press Inc
Erscheinungsdatum
1997
Sprache
Englisch
ISBN 10 
157491037X
ISBN 13 
9781574910377
Einband
Gebundene Ausgabe
Anzahl der Seiten
592
Kontakt zum Hersteller
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Verantwortliche Person
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