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: Sandy Weinberg
Publisher: CRC Press
ISBN: 9781566700252
Category : Science
Languages : en
Pages : 470

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Book Description
The GALP Regulatory Handbook is an easy-to-use manual to assist laboratories in applying the Good Automated Laboratory Practice guidelines published by the Environmental Protection Agency in 1990. The proliferation of computerized data collection has resulted in new problems of corruption, loss, and inappropriate modification in data provided to the EPA. The EPA published its GALP guidelines to aid laboratories replacing manual operations with computer technology. The eight chapters of this handbook provide a "how-to" framework for complying with those guidelines. The book looks at the extent and seriousness of those control issues for automated data collection systems, the intent of the GALPs in solving and preventing those problems, and the implementation guidelines that can help laboratory management maintain the compliance and quality that are fundamental to effective operation.

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: Sandy Weinberg
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249

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Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g

Author: Anton Bespalov
Publisher: Springer Nature
ISBN: 3030336565
Category : Cardiology
Languages : en
Pages : 424

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Book Description
This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.

Author: Sandy Weinberg
Publisher: CRC Press
ISBN:
Category : Biological laboratories
Languages : en
Pages : 320

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Book Description
This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references.

Author: United States Environmental Protection Agency (EPA)
Publisher: Createspace Independent Publishing Platform
ISBN: 9781723232329
Category :
Languages : en
Pages : 246

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Book Description
Good Automated Laboratory Practices : Draft : EPA's Recommendations for Ensuring Data Integrity in Automated Laboratory Operations with Implementation Guidance

Author: OECD
Publisher: OECD Publishing
ISBN: 9264173706
Category :
Languages : en
Pages : 42

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Book Description
These principles of corporate governance, endorsed by the OECD Council at Ministerial level in 1999, provide guidelines and standards to insure inclusion, accountability and abilit to attract capital.

Author: Matheus C. Carvalho
Publisher: John Wiley & Sons
ISBN: 3527341587
Category : Science
Languages : en
Pages : 246

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Book Description
By closing the gap between general programming books and those on laboratory automation, this timely book makes accessible to every laboratory technician or scientist what has traditionally been restricted to highly specialized professionals. Following the idea of "learning by doing", the book provides an introduction to scripting using AutoIt, with many workable examples based on real-world scenarios. A large portion of the book tackles the traditionally hard problem of instrument synchronization, including remote, web-based synchronization. Automated result processing, database operation, and creation of graphical user interfaces are also examined. Readers of this book can immediately profit from the new knowledge in terms of both increased efficiency and reduced costs in laboratory operation. Above all, laboratory technicians and scientists will learn that they are free to choose whatever equipment they desire when configuring an automated analytical setup, regardless of manufacturers suggested specifications.

Author: Sion Wyn
Publisher:
ISBN: 9781931879613
Category : Computer systems
Languages : en
Pages : 0

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Book Description
GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.