GAMP 5

GAMP 5
Author :
Publisher :
Total Pages : 0
Release :
ISBN-10 : 1931879613
ISBN-13 : 9781931879613
Rating : 4/5 (613 Downloads)

Book Synopsis GAMP 5 by : Sion Wyn

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.


GAMP 5 Related Books

GAMP 5
Language: en
Pages: 0
Authors: Sion Wyn
Categories: Computer systems
Type: BOOK - Published: 2008 - Publisher:

DOWNLOAD EBOOK

GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. T
Computer System Validation and GAMP 5
Language: en
Pages: 120
Authors: Vonlynx Solutions LLC
Categories:
Type: BOOK - Published: 2020-12-19 - Publisher: Independently Published

DOWNLOAD EBOOK

The purpose of this book is to help you understand how computerized systems are validated using the GAMP5framework. The information will be presented in a proje
Computer System Validation
Language: en
Pages: 0
Authors: Mindy Allport-Settle
Categories:
Type: BOOK - Published: 2021-03-31 - Publisher: PharmaLogika Books

DOWNLOAD EBOOK

Pharmaceutical Computer Systems Validation
Language: en
Pages: 773
Authors: Guy Wingate
Categories: Medical
Type: BOOK - Published: 2016-04-19 - Publisher: CRC Press

DOWNLOAD EBOOK

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification pri
Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Language: en
Pages: 480
Authors: Stephen Robert Goldman
Categories: Business & Economics
Type: BOOK - Published: 2003 - Publisher: 1st Book Library

DOWNLOAD EBOOK

This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutic