The TickIT Guide


Book Description




Pharmaceutical Computer Systems Validation


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.




A Software Process Model Handbook for Incorporating People's Capabilities


Book Description

A Software Process Model Handbook for Incorporating People's Capabilities offers the most advanced approach to date, empirically validated at software development organizations. This handbook adds a valuable contribution to the much-needed literature on people-related aspects in software engineering. The primary focus is on the particular challenge of extending software process definitions to more explicitly address people-related considerations. The capability concept is not present nor has it been considered in most software process models. The authors have developed a capabilities-oriented software process model, which has been formalized in UML and implemented as a tool. A Software Process Model Handbook for Incorporating People's Capabilities guides readers through the incorporation of the individual’s capabilities into the software process. Structured to meet the needs of research scientists and graduate-level students in computer science and engineering, this book is also suitable for practitioners in industry.




DSDM, Dynamic Systems Development Method


Book Description

DSDM is about people, not tools. It is about truly understanding the needs of a business, delivering software solutions that work and delivering them as quickly and as cheaply as possible. The Dynamic Systems Development Method provides a framework of controls and best practice for Rapid Application Development. It was created by a consortium of organisations and it has been proved, since its publication in January 1995, to be extremely effective in delivering maintainable systems which match the needs of the business better than those produced using traditional lifecycles. This book, commissioned by the DSDM Consortium and written by the chairman of the Technical Committee which developed the method, explores the day-to-day realities of implementing the method. It is a practitionerIs guide, dealing with issues such as how to get people from different disciplines to work together as a team, how to gain commitment and how to manage projects within normal business constraints. In this book you will find: practical guidelines on the implementation of key elements of the method such as "timeboxes" and the MOSCOW Rules clear recommendations for the roles and responsibilities of the members of the development team advice on which type of application is most likely to benefit from the method eight lengthy case studies by well-known companies, providing a benchmark against which to assess the suitability of candidate projects numerous examples and anecdotes, enabling the reader to benefit from the authorIs experience putting the method into practice Do you want to cut the development time and increase the fitness-for-use of screen based businessapplications, by orders of magnitude? This book will enable those in organisations which develop or purchase tailored IT systems, to gain a clear understanding of the benefits of the incremental and iterative approach embodied in the DSDM. 0201178893B04062001




ISO 9001:2000 Audit Procedures


Book Description

In order to meet the recommendations, requirements and specifications of ISO 9001:2000, organisations must undertake an audit of their own quality procedures and those of their suppliers. Likewise, when supplying ISO 9001:2000 accredited customers, suppliers must be prepared to undergo a similar audit. Revised, updated and expanded, ISO 9001:2000 Audit Procedures describes the methods for completing management reviews and quality audits, and outlines the experiences of working with 9001:2000 since its launch in 2000. It also includes essential new material on process models, generic pocesses, the requirements for mandatory documented procedures, and detailed coverage of auditors questionnaires.




Understanding ISO 9000 and Implementing the Basics to Quality


Book Description

This work examines the evolution and rationale of the ISO 9000 series of standards, their structure, interpretation and relationship to other quality systems. Theory and applications are provided, and the author explains how to put the standards into place and achieve quality. Specific methods and tools for the implementation of the ISO standards that lead to certification and certification maintenance are supplied.




Software Quality


Book Description

The book presents a comprehensive discussion on software quality issues and software quality assurance (SQA) principles and practices, and lays special emphasis on implementing and managing SQA. Primarily designed to serve three audiences; universities and college students, vocational training participants, and software engineers and software development managers, the book may be applicable to all personnel engaged in a software projects Features: A broad view of SQA. The book delves into SQA issues, going beyond the classic boundaries of custom-made software development to also cover in-house software development, subcontractors, and readymade software. An up-to-date wide-range coverage of SQA and SQA related topics. Providing comprehensive coverage on multifarious SQA subjects, including topics, hardly explored till in SQA texts. A systematic presentation of the SQA function and its tasks: establishing the SQA processes, planning, coordinating, follow-up, review and evaluation of SQA processes. Focus on SQA implementation issues. Specialized chapter sections, examples, implementation tips, and topics for discussion. Pedagogical support: Each chapter includes a real-life mini case study, examples, a summary, selected bibliography, review questions and topics for discussion. The book is also supported by an Instructor’s Guide.







Handbook Of Software Engineering And Knowledge Engineering, Vol 1: Fundamentals


Book Description

This is the first handbook to cover comprehensively both software engineering and knowledge engineering - two important fields that have become interwoven in recent years. Over 60 international experts have contributed to the book. Each chapter has been written in such a way that a practitioner of software engineering and knowledge engineering can easily understand and obtain useful information. Each chapter covers one topic and can be read independently of other chapters, providing both a general survey of the topic and an in-depth exposition of the state of the art. Practitioners will find this handbook useful when looking for solutions to practical problems. Researchers can use it for quick access to the background, current trends and most important references regarding a certain topic.The handbook consists of two volumes. Volume One covers the basic principles and applications of software engineering and knowledge engineering.Volume Two will cover the basic principles and applications of visual and multimedia software engineering, knowledge engineering, data mining for software knowledge, and emerging topics in software engineering and knowledge engineering.




International IT Regulations and Compliance


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.