Good Automated Laboratory Practices PDF Download

Author:
Publisher: DIANE Publishing
ISBN: 1428906126
Category : Environmental laboratories
Languages : en
Pages : 167

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Book Description

Author: Christine Paszko
Publisher: CRC Press
ISBN: 9780203908419
Category : Science
Languages : en
Pages : 246

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Book Description
Details the most recent advances in Laboratory Information Management Systems. Offers contemporary approaches to system development, design, and installation; system customization; software and hardware compatibility; quality assurance and regulatory requirements; and resource utilization.

Author: Donald C. Singer
Publisher: Quality Press
ISBN: 0873891090
Category : Business & Economics
Languages : en
Pages : 401

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Book Description
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation

Author: United States. Environmental Protection Agency
Publisher:
ISBN:
Category : Environmental protection
Languages : en
Pages : 204

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Book Description

Author: United States. Environmental Protection Agency
Publisher:
ISBN:
Category : Environmental protection
Languages : en
Pages : 214

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Book Description

Author: J.E.H. Stafford
Publisher: Springer Science & Business Media
ISBN: 9401106150
Category : Medical
Languages : en
Pages : 269

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Book Description
Laboratory Information Managements Systems (LIMS) are either custom-built or off-the-shelf solutions to the problems of controlling the flow of data through laboratories. In this book commercial relevance is ensured by authors from major industrial organizations who demonstrate by example successful application of the technology. This book provides an excellent up-to-date overview of this intensely competitive field.

Author: R D McDowall
Publisher: Royal Society of Chemistry
ISBN: 1788016629
Category : Science
Languages : en
Pages : 660

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Book Description
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.

Author: United States Environmental Protection Agency (EPA)
Publisher: Createspace Independent Publishing Platform
ISBN: 9781722793241
Category :
Languages : en
Pages : 166

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Book Description
Good Automated Laboratory Practices Principles And Guidance To Regulations For Ensuring Data Integrity In Automated Laboratory Operations With Implementation Guidance 1995 Edition

Author: Stephen W. Jenniss
Publisher: John Wiley & Sons
ISBN: 9780471190394
Category : Technology & Engineering
Languages : en
Pages : 280

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Book Description
A complete guide to regulatory compliance monitoring using atomic spectrometry This is the only comprehensive, single-volume guide to all methods of atomic spectrometry currently recognized by regulatory agencies for the monitoring of metallic contaminants. It is an indispensable working resource for analytical chemists and spectroscopists responsible for generating scientifically and legally defensible laboratory results for regulatory compliance. The book answers virtually every question regarding material selection, preparation, preservation, analysis, and the testing equipment itself. It begins with a thorough explication of the three major spectrometric methods: atomic absorption, inductively coupled plasma atomic spectrometry, and inductively coupled plasma mass spectrometry. Each method is described in terms of its scope of sensitivity, theoretical principles, material and equipment requirements, interferences and their corrections, and calibration. Following chapters provide detailed accounts of sample collection, preservation, and preparation; concentration and separation methods; and laboratory analysis methods for compliance monitoring of air, water, wastes, animal tissues, and food. The authors also provide helpful hints and guidelines on how to organize a laboratory; plan projects; report results; communicate with clients, regulators, and the public; market services; and more.

Author: International Validation Forum
Publisher: CRC Press
ISBN: 9780824794590
Category : Science
Languages : en
Pages : 1114

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Book Description
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."