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Author: Sion Wyn
Publisher:
ISBN: 9781931879613
Category : Computer systems
Languages : en
Pages : 0
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Book Description
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: Sion Wyn
Publisher:
ISBN: 9781931879613
Category : Computer systems
Languages : en
Pages : 0
Get Book Here
Book Description
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: Vonlynx Solutions LLC
Publisher: Independently Published
ISBN:
Category :
Languages : en
Pages : 120
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Book Description
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 project life cycle format. This will give you a solid idea howComputerized System Validation projects are conducted. This book is suited for anyone new to Computer SystemsValidation. It is written in a simple manner and can serve as starter guide which includes many high-level sample templates and illustration.
Author: Guy Wingate
Publisher: CRC Press
ISBN: 1420088955
Category : Medical
Languages : en
Pages : 773
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Book Description
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
Author:
Publisher: Ispe Headquarters
ISBN: 9781931879392
Category : Technology & Engineering
Languages : en
Pages :
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Book Description
Author: Siri H. Segalstad
Publisher: John Wiley & Sons
ISBN: 9780470721834
Category : Law
Languages : en
Pages : 338
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Book Description
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:
Publisher: Ispe Headquarters
ISBN: 9781931879422
Category : Technology & Engineering
Languages : en
Pages :
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Book Description
Author: Yolanda Gampp
Publisher: HarperCollins
ISBN: 1443453900
Category : Cooking
Languages : en
Pages : 552
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Book Description
From Yolanda Gampp, host of the massively popular, award-winning YouTube sensation “How to Cake It,” comes an inspiring “cakebook” with irresistible new recipes and visual instructions for creating spectacular novelty cakes for all skill levels. On her entertaining YouTube Channel, “How to Cake It,” Yolanda Gampp creates mind-blowing cakes in every shape imaginable. From a watermelon to a human heart to food-shaped cakes such as burgers and pizzas—Yolanda’s creations are fun and realistic. Now, Yolanda brings her friendly, offbeat charm and caking expertise to this colorful cakebook filled with imaginative cakes to make at home. How to Cake It: A Cakebook includes directions for making twenty-one jaw-dropping cakes that are gorgeous and delicious, including a few fan favorites with a fresh twist, and mind-blowing new creations. Yolanda shares her coveted recipes and pro tips, taking you step-by-step from easy, kid-friendly cakes (no carving necessary and simple fondant work) to more difficult designs (minimal carving and fondant detail) to aspirational cakes (carving, painting and gum-paste work). Whatever the celebration, Yolanda has the perfect creation, including her never before seen Candy Apple Cake, Party Hat, Rainbow Grilled Cheese Cake, Toy Bulldozer Cake and even a Golden Pyramid Cake, which features a secret treasure chamber! Written in her inspiring, encouraging voice and filled with clear, easy-to-follow instructions and vibrant photos, How to Cake It: A Cakebook will turn beginners into confident cake creators, and confident bakers into caking superstars!
Author: Orlando Lopez
Publisher: CRC Press
ISBN: 1315349973
Category : Business & Economics
Languages : en
Pages : 268
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Book Description
Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
Author: Bela G. Liptak
Publisher: CRC Press
ISBN: 1439817766
Category : Technology & Engineering
Languages : en
Pages : 1142
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Book Description
Instrument Engineers' Handbook – Volume 3: Process Software and Digital Networks, Fourth Edition is the latest addition to an enduring collection that industrial automation (AT) professionals often refer to as the "bible." First published in 1970, the entire handbook is approximately 5,000 pages, designed as standalone volumes that cover the measurement (Volume 1), control (Volume 2), and software (Volume 3) aspects of automation. This fourth edition of the third volume provides an in-depth, state-of-the-art review of control software packages used in plant optimization, control, maintenance, and safety. Each updated volume of this renowned reference requires about ten years to prepare, so revised installments have been issued every decade, taking into account the numerous developments that occur from one publication to the next. Assessing the rapid evolution of automation and optimization in control systems used in all types of industrial plants, this book details the wired/wireless communications and software used. This includes the ever-increasing number of applications for intelligent instruments, enhanced networks, Internet use, virtual private networks, and integration of control systems with the main networks used by management, all of which operate in a linked global environment. Topics covered include: Advances in new displays, which help operators to more quickly assess and respond to plant conditions Software and networks that help monitor, control, and optimize industrial processes, to determine the efficiency, energy consumption, and profitability of operations Strategies to counteract changes in market conditions and energy and raw material costs Techniques to fortify the safety of plant operations and the security of digital communications systems This volume explores why the holistic approach to integrating process and enterprise networks is convenient and efficient, despite associated problems involving cyber and local network security, energy conservation, and other issues. It shows how firewalls must separate the business (IT) and the operation (automation technology, or AT) domains to guarantee the safe function of all industrial plants. This book illustrates how these concerns must be addressed using effective technical solutions and proper management policies and practices. Reinforcing the fact that all industrial control systems are, in general, critically interdependent, this handbook provides a wide range of software application examples from industries including: automotive, mining, renewable energy, steel, dairy, pharmaceutical, mineral processing, oil, gas, electric power, utility, and nuclear power.
Author: Orlando Lopez
Publisher: CRC Press
ISBN: 1040083706
Category : Business & Economics
Languages : en
Pages : 262
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Book Description
Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is
