Ispe Guide

Author : Sion Wyn
Publisher :
ISBN 13 : 9781931879613
Total Pages : 0 pages
Book Rating : 4.13/5 ( download)

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Download or read book GAMP 5 written by Sion Wyn and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.

Author : ISPE
Publisher :
ISBN 13 : 9781931879255
Total Pages : 19 pages
Book Rating : 4.57/5 ( download)

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Download or read book GAMP Good Practice Guide written by ISPE and published by . This book was released on 2002 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author :
Publisher :
ISBN 13 : 9781931879569
Total Pages : 104 pages
Book Rating : 4.67/5 ( download)

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Download or read book ISPE Good Practice Guide written by and published by . This book was released on 2009 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Ispe
Publisher :
ISBN 13 : 9781931879361
Total Pages : 80 pages
Book Rating : 4.62/5 ( download)

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Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2005-09-05 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Ispe
Publisher :
ISBN 13 : 9781946964144
Total Pages : 148 pages
Book Rating : 4.4X/5 ( download)

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Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-01-24 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : William M. (Bill) Huitt
Publisher : John Wiley & Sons
ISBN 13 : 1119284252
Total Pages : 610 pages
Book Rating : 4.53/5 ( download)

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Download or read book Bioprocessing Piping and Equipment Design written by William M. (Bill) Huitt and published by John Wiley & Sons. This book was released on 2016-09-23 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard’s content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.

Author : International Society of Pharmaceutical Engineers
Publisher :
ISBN 13 : 9781936379422
Total Pages : 172 pages
Book Rating : 4.22/5 ( download)

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Download or read book ISPE Good Practice Guide written by International Society of Pharmaceutical Engineers and published by . This book was released on 2012 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Ispe
Publisher :
ISBN 13 : 9781946964175
Total Pages : 204 pages
Book Rating : 4.74/5 ( download)

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Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-03-25 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author :
Publisher : Ispe Headquarters
ISBN 13 : 9781931879422
Total Pages : pages
Book Rating : 4.27/5 ( download)

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Download or read book GAMP Good Practice Guide written by and published by Ispe Headquarters. This book was released on 2005 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author :
Publisher : Ispe Headquarters
ISBN 13 : 9781931879392
Total Pages : pages
Book Rating : 4.97/5 ( download)

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Download or read book GAMP Good Practice Guide written by and published by Ispe Headquarters. This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: