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Pharmaceutical Computer Systems Validation by Guy Wingate Pdf
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 r
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation by Orlando Lopez Pdf
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.
Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry by Stephen Robert Goldman Pdf
This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib
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.
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 by Jeffrey O. Grady Pdf
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.
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 assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture. The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.
System-level Test and Validation of Hardware/Software Systems by Matteo Sonza Reorda,Zebo Peng,Massimo Violante Pdf
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.
Managing the Documentation Maze by Janet Gough,David Nettleton Pdf
The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment’s notice. Written in a user-friendly Q&A style for quick reference, Managing the Documentation Maze provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on: Compliance with regulations in pharmaceutical, biological, and device record keeping Electronic systems, hybrid systems, and the entire scope of documentation that companies must manage How to write and edit documents that meet regulatory compliance Making the transition to an electronic system, including how to validate and document the process Anyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in place—one that will stand up to any type of scrutiny.
Embedded Systems and Software Validation by Abhik Roychoudhury Pdf
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?
Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Testing and Validation of Computer Simulation Models by David J. Murray-Smith Pdf
This must-read text/reference provides a practical guide to processes involved in the development and application of dynamic simulation models, covering a wide range of issues relating to testing, verification and validation. Illustrative example problems in continuous system simulation are presented throughout the book, supported by extended case studies from a number of interdisciplinary applications. Topics and features: provides an emphasis on practical issues of model quality and validation, along with questions concerning the management of simulation models, the use of model libraries, and generic models; contains numerous step-by-step examples; presents detailed case studies, often with accompanying datasets; includes discussion of hybrid models, which involve a combination of continuous system and discrete-event descriptions; examines experimental modeling approaches that involve system identification and parameter estimation; offers supplementary material at an associated website.
