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Author : Ispe
Publisher :
ISBN 13 : 9781931879415
Total Pages : pages
Book Rating : 4.8/5 (794 download)
Download or read book ISPE GAMP® Good Practice Guide: Validation of Laboratory Computerized Systems written by Ispe and published by . This book was released on 2007-04-05 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Sion Wyn
Publisher :
ISBN 13 : 9781931879613
Total Pages : 0 pages
Book Rating : 4.8/5 (796 download)
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 : Good Automated Manufacturing Practice Forum
Publisher :
ISBN 13 : 9781936379484
Total Pages : 156 pages
Book Rating : 4.3/5 (794 download)
Download or read book A Risk-based Approach to GxP Compliant Laboratory Computerized Systems written by Good Automated Manufacturing Practice Forum and published by . This book was released on 2012 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Siri H. Segalstad
Publisher : John Wiley & Sons
ISBN 13 : 9780470721834
Total Pages : 338 pages
Book Rating : 4.7/5 (218 download)
Download or read book International IT Regulations and Compliance written by Siri H. Segalstad and published by John Wiley & Sons. This book was released on 2008-11-20 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.
Author : Ispe
Publisher :
ISBN 13 : 9781931879828
Total Pages : pages
Book Rating : 4.8/5 (798 download)
Download or read book ISPE GAMP® Good Practice Guide written by Ispe and published by . This book was released on 2010-03-24 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781936379019
Total Pages : pages
Book Rating : 4.3/5 (79 download)
Download or read book ISPE GAMP® Good Practice Guide: a Risk-Based Approach to Operation of GxP Computerized Systems written by Ispe and published by . This book was released on 2010-11-08 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781936379033
Total Pages : pages
Book Rating : 4.3/5 (79 download)
Download or read book ISPE GAMP® Good Practice Guide: a Risk-Based Approach to Operation of GxP Computerized Systems written by Ispe and published by . This book was released on 2011-08-09 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Good Automated Manufacturing Practice Forum
Publisher :
ISBN 13 : 9781936379507
Total Pages : 272 pages
Book Rating : 4.3/5 (795 download)
Download or read book A Risk-based Approach to Testing of GxP Systems written by Good Automated Manufacturing Practice Forum and published by . This book was released on 2012 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ludwig Huber
Publisher : CRC Press
ISBN 13 : 1000948226
Total Pages : 268 pages
Book Rating : 4.0/5 (9 download)
Download or read book Validation of Computerized Analytical Systems written by Ludwig Huber and published by CRC Press. This book was released on 2023-04-28 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details. International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
Author :
Publisher :
ISBN 13 : 9781931879682
Total Pages : 212 pages
Book Rating : 4.8/5 (796 download)
Download or read book A Risk-based Approach to Operation of GxP Computerized Systems written by and published by . This book was released on 2009 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : International Society of Pharmaceutical Engineers
Publisher :
ISBN 13 : 9781936379040
Total Pages : 192 pages
Book Rating : 4.3/5 (79 download)
Download or read book GAMP Good Practice Guide written by International Society of Pharmaceutical Engineers and published by . This book was released on 2011 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781931879958
Total Pages : 352 pages
Book Rating : 4.8/5 (799 download)
Download or read book Ispe Gamp® 5 written by Ispe and published by . This book was released on 2010-08-15 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher : Ispe Headquarters
ISBN 13 : 9781931879392
Total Pages : pages
Book Rating : 4.8/5 (793 download)
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:
Author : Ispe
Publisher :
ISBN 13 : 9781936379910
Total Pages : 160 pages
Book Rating : 4.3/5 (799 download)
Download or read book ISPE GAMP® Good Practice Guide written by Ispe and published by . This book was released on 2017-02-22 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781936379316
Total Pages : pages
Book Rating : 4.3/5 (793 download)
Download or read book ISPE GAMP® Good Practice Guide: a Risk-Based Approach to GxP Process Control Systems written by Ispe and published by . This book was released on 2013-01-31 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781931879637
Total Pages : 352 pages
Book Rating : 4.8/5 (796 download)
Download or read book GAMP 5 : a risk-based approach to compliant GxP computerized systems (German version) written by Ispe and published by . This book was released on 2008-12-18 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781946964335
Total Pages : pages
Book Rating : 4.9/5 (643 download)
Download or read book ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design written by Ispe and published by . This book was released on 2020-11-17 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
