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Author : R. Timothy Stein
Publisher : Paton Professional
ISBN 13 : 9781932828092
Total Pages : 610 pages
Book Rating : 4.8/5 (28 download)
Download or read book The Computer System Risk Management and Validation Life Cycle written by R. Timothy Stein and published by Paton Professional. This book was released on 2006 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David A. Vogel
Publisher : Artech House
ISBN 13 : 1596934239
Total Pages : 445 pages
Book Rating : 4.5/5 (969 download)
Download or read book Medical Device Software Verification, Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
Author : Dean Leffingwell
Publisher : Pearson Education
ISBN 13 : 0321630068
Total Pages : 635 pages
Book Rating : 4.3/5 (216 download)
Download or read book Scaling Software Agility written by Dean Leffingwell and published by Pearson Education. This book was released on 2007-02-26 with total page 635 pages. Available in PDF, EPUB and Kindle. Book excerpt: “Companies have been implementing large agile projects for a number of years, but the ‘stigma’ of ‘agile only works for small projects’ continues to be a frequent barrier for newcomers and a rallying cry for agile critics. What has been missing from the agile literature is a solid, practical book on the specifics of developing large projects in an agile way. Dean Leffingwell’s book Scaling Software Agility fills this gap admirably. It offers a practical guide to large project issues such as architecture, requirements development, multi-level release planning, and team organization. Leffingwell’s book is a necessary guide for large projects and large organizations making the transition to agile development.” —Jim Highsmith, director, Agile Practice, Cutter Consortium, author of Agile Project Management “There’s tension between building software fast and delivering software that lasts, between being ultra-responsive to changes in the market and maintaining a degree of stability. In his latest work, Scaling Software Agility, Dean Leffingwell shows how to achieve a pragmatic balance among these forces. Leffingwell’s observations of the problem, his advice on the solution, and his description of the resulting best practices come from experience: he’s been there, done that, and has seen what’s worked.” —Grady Booch, IBM Fellow Agile development practices, while still controversial in some circles, offer undeniable benefits: faster time to market, better responsiveness to changing customer requirements, and higher quality. However, agile practices have been defined and recommended primarily to small teams. In Scaling Software Agility, Dean Leffingwell describes how agile methods can be applied to enterprise-class development. Part I provides an overview of the most common and effective agile methods. Part II describes seven best practices of agility that natively scale to the enterprise level. Part III describes an additional set of seven organizational capabilities that companies can master to achieve the full benefits of software agility on an enterprise scale. This book is invaluable to software developers, testers and QA personnel, managers and team leads, as well as to executives of software organizations whose objective is to increase the quality and productivity of the software development process but who are faced with all the challenges of developing software on an enterprise scale.
Author : Michael Butler
Publisher : Springer
ISBN 13 : 3540766502
Total Pages : 397 pages
Book Rating : 4.5/5 (47 download)
Download or read book Formal Methods and Software Engineering written by Michael Butler and published by Springer. This book was released on 2007-10-27 with total page 397 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 9th International Conference on Formal Engineering Methods, ICFEM 2007, held in Boca Raton, Florida, USA, November 14-15, 2007. The 19 revised full papers together with two invited talks presented were carefully reviewed and selected from 38 submissions. The papers address all current issues in formal methods and their applications in software engineering. The papers are organized in topical sections.
Author : Robert McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 1847552293
Total Pages : 289 pages
Book Rating : 4.8/5 (475 download)
Download or read book Validation of Chromatography Data Systems written by Robert McDowall and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.
Author : Robert D. McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 1849736626
Total Pages : 778 pages
Book Rating : 4.8/5 (497 download)
Download or read book Validation of Chromatography Data Systems written by Robert D. McDowall and published by Royal Society of Chemistry. This book was released on 2016-11-25 with total page 778 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.
Author : Guy Wingate
Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 773 pages
Book Rating : 4.4/5 (2 download)
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Péter Horvatovich
Publisher : Royal Society of Chemistry
ISBN 13 : 1849734364
Total Pages : 385 pages
Book Rating : 4.8/5 (497 download)
Download or read book Comprehensive Biomarker Discovery and Validation for Clinical Application written by Péter Horvatovich and published by Royal Society of Chemistry. This book was released on 2013-06-17 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on proteomics biomarker discovery and validation procedures from the clinical perspective. It provides an overview of current technology and the challenges encountered throughout the process. This covers all key stages, from biomarker discovery and validation, through to registration with the European and US regulatory authorities (FDA and EMEA). All the important elements (such as patient selection, sample handling, data processing, and statistical analysis) are described in detail and the reader is introduced to each topic with well-described examples or guidelines for best practice. Case studies are also included to demonstrate clinical applications. Individual chapters explain the best performing techniques for profiling complex body fluids and biomarker discovery. This includes the application of mass spectrometry imaging combined with chromatography in profiling platforms and the use of laser micro dissection and MALDI imaging to study tissues in their natural environment. Future developments needed to improve the success rate of translating biomarker discovery into useful clinical tests are also discussed. Common pitfalls and success stories are described as are the limitations of the various technologies involved. Broad and interdisciplinary in approach, this book provides an excellent source of information for industrial and academic researchers, and those managing biobanks.
Author : Orlando Lopez
Publisher : CRC Press
ISBN 13 : 1482243636
Total Pages : 372 pages
Book Rating : 4.4/5 (822 download)
Download or read book EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP written by Orlando Lopez and published by CRC Press. This book was released on 2015-04-06 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Author : Antonia Mas
Publisher : Springer
ISBN 13 : 3642304397
Total Pages : 314 pages
Book Rating : 4.6/5 (423 download)
Download or read book Software Process Improvement and Capability Determination written by Antonia Mas and published by Springer. This book was released on 2012-06-02 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 12th International Conference on Software Process Improvement and Capability Determination, SPICE 2012, held in Palma de Mallorca, Spain, in May 2012. The 21 revised full papers presented and 14 short papers were carefully reviewed and selected from numerous submissions. The papers are organized in topical sections on organizational process improvement; SPI in small and very small enterprises; process models; SPI in automotive software and security; SPI in medical and safety critical systems; short papers.
Author : Kanellis, Panagiotis
Publisher : IGI Global
ISBN 13 : 1591408741
Total Pages : 357 pages
Book Rating : 4.5/5 (914 download)
Download or read book Digital Crime and Forensic Science in Cyberspace written by Kanellis, Panagiotis and published by IGI Global. This book was released on 2006-04-30 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Digital forensics is the science of collecting the evidence that can be used in a court of law to prosecute the individuals who engage in electronic crime"--Provided by publisher.
Author : Amiram Daniel
Publisher : Quality Press
ISBN 13 : 0873892046
Total Pages : 344 pages
Book Rating : 4.8/5 (738 download)
Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-02-21 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.
Author : Lazakidou, Athina A.
Publisher : IGI Global
ISBN 13 : 1605660035
Total Pages : 600 pages
Book Rating : 4.6/5 (56 download)
Download or read book Handbook of Research on Distributed Medical Informatics and E-Health written by Lazakidou, Athina A. and published by IGI Global. This book was released on 2008-08-31 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides coverage of specific topics and issues in healthcare, highlighting recent trends and describing the latest advances in the field.
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1482226375
Total Pages : 1012 pages
Book Rating : 4.4/5 (822 download)
Download or read book Handbook of Bioequivalence Testing, Second Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2014-10-29 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.
Author : Orlando Lopez
Publisher : Taylor & Francis
ISBN 13 : 1351704346
Total Pages : 232 pages
Book Rating : 4.3/5 (517 download)
Download or read book Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation written by Orlando Lopez and published by Taylor & Francis. This book was released on 2018-10-02 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Xenophon Papademetris
Publisher : Cambridge University Press
ISBN 13 : 1316514994
Total Pages : 341 pages
Book Rating : 4.3/5 (165 download)
Download or read book Introduction to Medical Software written by Xenophon Papademetris and published by Cambridge University Press. This book was released on 2022-05-05 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise and accessible overview of the design, implementation and management of medical software.
Author : Rommel Garcia
Publisher : Xlibris Corporation
ISBN 13 : 1524589209
Total Pages : 403 pages
Book Rating : 4.5/5 (245 download)
Download or read book Medical Device written by Rommel Garcia and published by Xlibris Corporation. This book was released on 2017-06-06 with total page 403 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.
