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

Wingate, Guy

Rilegato

ISBN 10: 157491037X ISBN 13: 9781574910377

Casa editrice: CRC Press, 1997

Riassunto

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).

Su questo libro

Contenuti

Chapters include:
o History of Validation o Organization
o Validating Automation Systems o Validation Strategies
o Ongoing Support o Working Relationships
o Validation Capability o Topical Issues
Case Studies:
o Validating Instrumentation
o Validating Programmable Logic Controllers (PLC)
o Validating Industrial Personal Computer Systems (IPC)
o Validating Supervisory Control and Data Acquisition Systems (SCADA)
o Validating Distributed Control Systems (DCS)
o Validating Manufacturing Execution Systems (MES)
o Validating Manufacturing Resource Planning Systems (MRP II)
o Validating Maintenance and Calibration Computer Systems
o Validating Engineering Management Systems (EMS)
o Validating Building Management Systems (BMS)
o Validating Laboratory Automation Systems
o Validating Laboratory Information Management Systems (LIMS)
o Validating Electronic Documentation Management Systems (EDMS)
o Validating Electronic Batch Record Systems (EBRS)
o Validating Automated Medical Devices

Product Description

Hard to Find book

Dettagli dell'edizione

• Editore: CRC Press
• Data di pubblicazione: 1997
• Lingua: Inglese
• ISBN 10: 157491037X
• ISBN 13: 9781574910377
• Rilegatura: Copertina rigida
• Numero edizione: 1
• Numero di pagine: 592
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile