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

Wingate, Guy

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

Synopsis

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).

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

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).

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
CRC Press Inc
Date d'édition
1997
Langue
anglais
ISBN 10 
157491037X
ISBN 13 
9781574910377
Reliure
Relié
Nombre de pages
592
Coordonnées du fabricant
non disponible
Personne responsable
non disponible