Quality Assurance Implementation in Research Labs PDF Download

Author: Akshay Anand
Publisher: Springer Nature
ISBN: 9811630747
Category : Medical
Languages : en
Pages : 247

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Book Description
This book is a comprehensive and timely compilation of strategy, methods, and implementation of a proof of concept modified quality module of Good Laboratory Practices (GLP). This text provides a historical overview of GLP and related standards of quality assurance practices in clinical testing laboratories as well as basic research settings. It specifically discusses the need and challenges in audit, documentation, and strategies for its implications in system-dependent productivity striving research laboratories. It also describes the importance of periodic training of study directors as well as the scholars for standardization in research processes. This book describes different documents required at various time points of a successful Ph.D and post-doc tenure along with faculty training besides entire lab establishments. Various other areas including academic social responsibility and quality assurance in the developing world, lab orientations, and communication, digitization in data accuracy, auditability and back traceability have also been discussed. This book will be a preferred source for principal investigators, research scholars, and industrial research centers globally. From the foreword by Ratan Tata, India “This book will be a guide for students and professionals alike in quality assurance practices related to clinical research labs. The historical research and fundamental principles make it a good tool in clinical research environments. The country has a great need for such a compilation in order to increase the application of domestic capabilities and technology”

Author: Mary D. Hinton
Publisher: Marcel Dekker
ISBN: 9780824794583
Category : Science
Languages : en
Pages : 345

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Book Description
This practical resource discusses the fundamentals of laboratory information management systems (LIMS) and the steps required to develop a customized system or install an existing system - analyzing in detail the validation aspects of quality assurance and providing specific examples of LIMS validation methods. Written by an acknowledged LIMS expert and research chemist, Laboratory Information Management Systems is an incomparable hands-on guide for analytical chemists; quality and reliability managers and directors; industrial, manufacturing, process, design, cost, chemical, pharmaceutical, petroleum, and environmental engineers; laboratory information systems and management information systems managers; computer scientists; and upper-level undergraduate and graduate students in these disciplines.

Author: Gaffar Zaman
Publisher: BoD – Books on Demand
ISBN: 1789234123
Category : Business & Economics
Languages : en
Pages : 160

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Book Description
The book presents a qualitative and quantitative approach to understand, manage and enforce the integration of statistical concepts into quality control and quality assurance methods. Utilizing a sound theoretical and practical foundation and illustrating procedural techniques through scientific examples, this book bridges the gap between statistical quality control, quality assurance and quality management. Detailed procedures have been omitted because of the variety of equipment and commercial kits used in today's clinical laboratories. Instrument manuals and kit package inserts are the most reliable reference for detailed instructions on current analytical procedures.

Author: Philip Carson
Publisher: Royal Society of Chemistry
ISBN: 1847557724
Category : Science
Languages : en
Pages : 656

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Book Description
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.

Author: Thomas A. Ratliff
Publisher: Wiley-Interscience
ISBN: 9780471269182
Category : Technology & Engineering
Languages : en
Pages : 248

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Book Description
Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual: -Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories. -Provides blank forms used in preparing a quality manual. -Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.

Author: D. Brynn Hibbert
Publisher: Oxford University Press
ISBN: 9780198036722
Category : Science
Languages : en
Pages : 320

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Book Description
Analytical chemical results touch everyones lives can we eat the food? do I have a disease? did the defendant leave his DNA at the crime scene? should I invest in that gold mine? When a chemist measures something how do we know that the result is appropriate? What is fit for purpose in the context of analytical chemistry? Many manufacturing and service companies have embraced traditional statistical approaches to quality assurance, and these have been adopted by analytical chemistry laboratories. However the right chemical answer is never known, so there is not a direct parallel with the manufacture of ball bearings which can be measured and assessed. The customer of the analytical services relies on the quality assurance and quality control procedures adopted by the laboratory. It is the totality of the QA effort, perhaps first brought together in this text, that gives the customer confidence in the result. QA in the Analytical Chemistry Laboratory takes the reader through all aspects of QA, from the statistical basics and quality control tools to becoming accredited to international standards. The latest understanding of concepts such as measurement uncertainty and metrological traceability are explained for a working chemist or her client. How to design experiments to optimize an analytical process is included, together with the necessary statistics to analyze the results. All numerical manipulation and examples are given as Microsoft Excel spreadsheets that can be implemented on any personal computer. Different kinds of interlaboratory studies are explained, and how a laboratory is judged in proficiency testing schemes is described. Accreditation to ISO 17025 or OECD GLP is nearly obligatory for laboratories of any pretension to quality. Here the reader will find an introduction to the requirements and philosophy of accreditation. Whether completing a degree course in chemistry or working in a busy analytical laboratory, this book is a single source for an introduction into quality assurance.

Author:
Publisher: United Nations Publications
ISBN: 9789211482539
Category : Medical
Languages : en
Pages : 42

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Book Description
The field of quality assurance is beset by an extensive and sometimes confusing terminology, the use of which has still not been universally agreed on or accepted by laboratories or interested professional bodies worldwide. This glossary contains some of the most commonly used expressions in these fields, including those which appear in UNODC publications on quality assurance, and is an attempt to help promote and harmonise national efforts by providing internationally acceptable terminology. It is intended to be an aid to analysts in the implementation of quality assurance programmes and good laboratory practices, and is provided to laboratories as an educational document, and as a means of encouraging laboratories to collaborate and participate in quality assurance matters. As a result, the Glossary includes more than one definition of a word or phrase where these might improve understanding of what they mean. The current publication is an update of the first edition of the Glossary of Quality Assurance Terms. This second edition includes many new terms which have appeared in UNODC publications since the Glossary was first published.

Author: Masahiko Amano
Publisher: World Scientific
ISBN: 981121249X
Category : Medical
Languages : en
Pages : 274

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Book Description
This book explains how SaaS works and lists and describes many common misconceptions and pitfalls that laboratories have about implementing Quality Management Systems (QMS). By walking the reader through all ISO 15189 Standards and describing each in detail, we can show how to implement them in common sense and meaningful ways. This book demonstrates to clinical laboratories how to combine the rigor of international standards with the inherent benefits of contemporary cloud-based software systems so that they can involve the entire laboratory in making quality a shared habit.

Author: Elizabeth Prichard
Publisher: John Wiley & Sons
ISBN: 9780470517765
Category : Science
Languages : en
Pages : 316

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Book Description
The issue of quality assurance in the analytical chemistry laboratory has become of great importance in recent years. Quality Assurance in Analytical Chemistry introduces the reader to the whole concept of quality assurance. It discusses how all aspects of chemical analysis, from sampling and method selection to choice of equipment and the taking and reporting of measurements affect the quality of analytical data. Finally, the implementation and use of quality systems are covered.

Author: Frederick M. Garfield
Publisher: Association of Official Analytical Chemist
ISBN:
Category : Science
Languages : en
Pages : 214

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Book Description
Quality assurance planning. statistical applications and control charts. Personel considerations. Management of equipment and supplies. Sample and record handling. Sampling and sample analysis. Proficiency and check samples. Audit procedures. Design and safety of facilities. Laboratory accreditation.