Author: American Institute of Certified Public Accountants. Computer Applications Subcommittee
Publisher:
ISBN:
Category : Accounting
Languages : en
Pages : 60

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Book Description

Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 47

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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: 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."

Author: United States. Securities and Exchange Commission
Publisher:
ISBN:
Category : Accountants
Languages : en
Pages : 1210

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Author:
Publisher:
ISBN: 9780686702344
Category :
Languages : en
Pages :

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Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 1680

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Author: International Validation Forum
Publisher: CRC Press
ISBN: 9780824797461
Category : Science
Languages : en
Pages : 860

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Book Description
This biannual offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries. It addresses significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. It examines Good Manufacturing Principles (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), Good Automated Library Practices (GALPs), and others, and elucidates up-to-the-minute industry changes and international concerns.

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0824745647
Category : Medical
Languages : en
Pages : 256

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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 guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.

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