GALP Regulatory Handbook

Front Cover
CRC Press, Jun 2, 1994 - Science - 464 pages
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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.
 

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Contents

Importance of Automation
2
GALP Principles
8
GALP Requirements
21
Documentation
43
Validation
77
Tools for GALPs Compliance
89
Regulatory Issues
169
REFERENCES
179
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