Computer System Validation
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Pharmaceutical And Medical Devices Manufacturing Computer Systems Validation
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Author : Orlando Lopez
language : en
Publisher: Taylor & Francis
Release Date : 2018-10-02
Pharmaceutical And Medical Devices Manufacturing Computer Systems Validation written by Orlando Lopez and has been published by Taylor & Francis this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-02 with Business & Economics categories.
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Pharmaceutical Computer Systems Validation
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Pharmaceutical Computer Systems Validation written by Guy Wingate and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
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.
Validation Of Computerized Analytical Systems
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Author : Ludwig Huber
language : en
Publisher: CRC Press
Release Date : 2023-04-28
Validation Of Computerized Analytical Systems written by Ludwig Huber and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-04-28 with Medical categories.
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.
21 Cfr Part 11
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Author : Orlando López
language : en
Publisher: CRC Press
Release Date : 2004-01-15
21 Cfr Part 11 written by Orlando López and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-01-15 with Medical categories.
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places
System Validation And Verification
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Author : Jeffrey O. Grady
language : en
Publisher: CRC Press
Release Date : 1997-11-25
System Validation And Verification written by Jeffrey O. Grady and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997-11-25 with Technology & Engineering categories.
Historically, the terms validation and verification have been very loosely defined in the system engineering world, with predictable confusion. Few hardware or software testing texts even touch upon validation and verification, despite the fact that, properly employed, these test tools offer system and test engineers powerful techniques for identifying and solving problems early in the design process. Together, validation and verification encompass testing, analysis, demonstration, and examination methods used to determine whether a proposed design will satisfy system requirements. System Validation and Verification clear definitions of the terms and detailed information on using these fundamental tools for problem solving. It smoothes the transition between requirements and design by providing methods for evaluating the ability of a given approach to satisfy demanding technical requirements. With this book, system and test engineers and project managers gain confidence in their designs and lessen the likelihood of serious problems cropping up late in the program. In addition to explanations of the theories behind the concepts, the book includes practical methods for each step of the process, examples from the author's considerable experience, and illustrations and tables to support the ideas. Although not primarily a textbook, System Validation and Verification is based in part on validation and verification courses taught by the author and is an excellent supplemental reference for engineering students. In addition to its usefulness to system engineers, the book will be valuable to a wider audience including manufacturing, design, software , and risk management project engineers - anyone involved in large systems design projects.
Embedded Systems And Software Validation
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Author : Abhik Roychoudhury
language : en
Publisher: Morgan Kaufmann
Release Date : 2009-04-29
Embedded Systems And Software Validation written by Abhik Roychoudhury and has been published by Morgan Kaufmann this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-04-29 with Computers categories.
Modern embedded systems require high performance, low cost and low power consumption. Such systems typically consist of a heterogeneous collection of processors, specialized memory subsystems, and partially programmable or fixed-function components. This heterogeneity, coupled with issues such as hardware/software partitioning, mapping, scheduling, etc., leads to a large number of design possibilities, making performance debugging and validation of such systems a difficult problem. Embedded systems are used to control safety critical applications such as flight control, automotive electronics and healthcare monitoring. Clearly, developing reliable software/systems for such applications is of utmost importance. This book describes a host of debugging and verification methods which can help to achieve this goal. - Covers the major abstraction levels of embedded systems design, starting from software analysis and micro-architectural modeling, to modeling of resource sharing and communication at the system level - Integrates formal techniques of validation for hardware/software with debugging and validation of embedded system design flows - Includes practical case studies to answer the questions: does a design meet its requirements, if not, then which parts of the system are responsible for the violation, and once they are identified, then how should the design be suitably modified?
Validation Verification And Testing Of Computer Software
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Author : W. Richards Adrion
language : en
Publisher:
Release Date : 1981
Validation Verification And Testing Of Computer Software written by W. Richards Adrion and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1981 with Computer programs categories.
Computer Systems Validation
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2003-12-18
Computer Systems Validation written by Guy Wingate and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-12-18 with Medical categories.
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality
System Level Test And Validation Of Hardware Software Systems
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Author : Matteo Sonza Reorda
language : en
Publisher: Springer Science & Business Media
Release Date : 2006-03-30
System Level Test And Validation Of Hardware Software Systems written by Matteo Sonza Reorda and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-03-30 with Technology & Engineering categories.
New manufacturing technologies have made possible the integration of entire systems on a single chip. This new design paradigm, termed system-on-chip (SOC), together with its associated manufacturing problems, represents a real challenge for designers. SOC is also reshaping approaches to test and validation activities. These are beginning to migrate from the traditional register-transfer or gate levels of abstraction to the system level. Until now, test and validation have not been supported by system-level design tools so designers have lacked the infrastructure to exploit all the benefits stemming from the adoption of the system level of abstraction. Research efforts are already addressing this issue. This monograph provides a state-of-the-art overview of the current validation and test techniques by covering all aspects of the subject including: modeling of bugs and defects; stimulus generation for validation and test purposes (including timing errors; design for testability.
The Computer System Risk Management And Validation Life Cycle
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Author : R. Timothy Stein
language : en
Publisher: Paton Professional
Release Date : 2006
The Computer System Risk Management And Validation Life Cycle written by R. Timothy Stein and has been published by Paton Professional this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Business & Economics categories.