Validation Of Chromatography Data Systems
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Validation Of Chromatography Data Systems
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Author : Robert D McDowall
language : en
Publisher: Royal Society of Chemistry
Release Date : 2007-10-31
Validation Of Chromatography Data Systems written by Robert D McDowall and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-10-31 with Science categories.
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
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Author : R. D. McDowall
language : en
Publisher: Royal Society of Chemistry
Release Date : 2005
Validation Of Chromatography Data Systems written by R. D. McDowall and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Computers categories.
This title introduces the basics of computer validation. It is ideal for the chromatographer and will be welcomed by consultants or those in regulatory agencies.
Validation Of Chromatography Data Systems
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Author : Robert D McDowall
language : en
Publisher: Royal Society of Chemistry
Release Date : 2016-11-23
Validation Of Chromatography Data Systems written by Robert D McDowall and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-23 with Science categories.
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.
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
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.
Data Integrity And Data Governance
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Author : R. D. McDowall
language : en
Publisher: Royal Society of Chemistry
Release Date : 2018-11-09
Data Integrity And Data Governance written by R. D. McDowall and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-09 with Computers categories.
This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Data Integrity And Data Governance
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Author : Robert D McDowall
language : en
Publisher: Royal Society of Chemistry
Release Date : 2018-11-06
Data Integrity And Data Governance written by Robert D McDowall and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-06 with Science categories.
Data integrity is the hottest topic in the pharmaceutical industry. Global regulatory agencies have issued guidance, after guidance after guidance in the past few years, most of which does not offer practical advice on how to implement policies, procedures and processes to ensure integrity. These guidances state what but not how. Additionally, key stages of analysis that impact data integrity are omitted entirely. The aim of this book is to provide practical and detailed help on how to implement data integrity and data governance for regulated analytical laboratories working in or for the pharmaceutical industry. It provides clarification of the regulatory issues and trends, and gives practical methods for meeting regulatory requirements and guidance. Using a data integrity model as a basis, the principles of data integrity and data governance are expanded into practical steps for regulated laboratories to implement. The author uses case study examples to illustrate his points and provides instructions for applying the principles of data integrity and data governance to individual laboratory needs. This book is a useful reference for analytical chemists and scientists, management and senior management working in regulated laboratories requiring either an understanding about data integrity or help in implementing practical solutions. Consultants will also benefit from the practical guidance provided.
Handbook Of Ion Chromatography
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Author : Joachim Weiss
language : en
Publisher: John Wiley & Sons
Release Date : 2016-06-24
Handbook Of Ion Chromatography written by Joachim Weiss and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-06-24 with Science categories.
This three-volume handbook is the standard reference in the field, unparalleled in its comprehensiveness. It covers every conceivable topic related to the expanding and increasingly important field of ion chromatography. The fourth edition is completely updated and revised to include the latest developments in the instrumentation, now stretching to three volumes to reflect the current state of applications. Ion chromatography is one of the most widely used separation techniques of analytical chemistry with applications in fields such as medicinal chemistry, water chemistry and materials science. Consequently, the number of users of this method is continuously growing, underlining the need for an up-to-date reference. A true pioneer of this method, Joachim Weiss studied chemistry at the Technical University of Berlin (Germany), where he also received his PhD degree in Analytical Chemistry. In 2002, he did his habilitation in Analytical Chemistry at the Leopold-Franzens University in Innsbruck (Austria), where he is also teaching liquid chromatography. Since 1982, Dr. Weiss has worked at Dionex (now being part of Thermo Fisher Scientific), where he currently holds the position of Technical Director for Dionex Products within the Chromatography and Mass Spectrometry Division (CMD) of Thermo Fisher Scientific, located in Dreieich (Germany).
Handbook Of Pharmaceutical Analysis By Hplc
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Author : Satinder Ahuja
language : en
Publisher: Elsevier
Release Date : 2005-02-09
Handbook Of Pharmaceutical Analysis By Hplc written by Satinder Ahuja and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-02-09 with Medical categories.
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Handbook Of Analytical Validation
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Author : Michael E. Swartz
language : en
Publisher: CRC Press
Release Date : 2012-04-24
Handbook Of Analytical Validation written by Michael E. Swartz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-24 with Science categories.
Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.