Medical Device Software Verification, Validation and Compliance

Medical Device Software Verification, Validation and Compliance

Author: David A. Vogel

Publisher: Artech House

Published: 2011

Total Pages: 445

ISBN-13: 1596934239

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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."


Scaling Software Agility

Scaling Software Agility

Author: Dean Leffingwell

Publisher: Pearson Education

Published: 2007-02-26

Total Pages: 635

ISBN-13: 0321630068

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“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.


Formal Methods and Software Engineering

Formal Methods and Software Engineering

Author: Michael Butler

Publisher: Springer

Published: 2007-10-27

Total Pages: 397

ISBN-13: 3540766502

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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.


Validation of Chromatography Data Systems

Validation of Chromatography Data Systems

Author: Robert McDowall

Publisher: Royal Society of Chemistry

Published: 2007-10-31

Total Pages: 289

ISBN-13: 1847552293

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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.


Validation of Chromatography Data Systems

Validation of Chromatography Data Systems

Author: Robert D. McDowall

Publisher: Royal Society of Chemistry

Published: 2016-11-25

Total Pages: 778

ISBN-13: 1849736626

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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.


Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation

Author: Guy Wingate

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 773

ISBN-13: 1420088955

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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.


Comprehensive Biomarker Discovery and Validation for Clinical Application

Comprehensive Biomarker Discovery and Validation for Clinical Application

Author: Péter Horvatovich

Publisher: Royal Society of Chemistry

Published: 2013-06-17

Total Pages: 385

ISBN-13: 1849734364

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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.


EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Author: Orlando Lopez

Publisher: CRC Press

Published: 2015-04-06

Total Pages: 372

ISBN-13: 1482243636

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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


Software Process Improvement and Capability Determination

Software Process Improvement and Capability Determination

Author: Antonia Mas

Publisher: Springer

Published: 2012-06-02

Total Pages: 314

ISBN-13: 3642304397

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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.