GALP Regulatory Handbook
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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Importance of Automation
Tools for GALPs Compliance
acceptance testing additional guidance adequate application software appropriate archives audit trail authorized automated data collection Automated Laboratory Practices Automated Laboratory Standards automated system Backup and Recovery Change Control Procedures compliance computer system computer-resident data conduct Control Act TSCA criteria data collection system data corruption data entry data integrity define documentation Electronic Reporting ensure environment environmental EPA's equipment established evaluation EXPLANATION EXAMPLE Federal Fungicide FIFRA GALP standards GLPs guidelines hardware historical file identified implemented in-house individual inspection laboratory management laboratory operations Laboratory Practices 1989 magnetic media maintained maintenance manuals operational instructions password Personal Computers physical security Principle Problem Reporting programs protection quality assurance unit raw data records regulatory Responsible Person retained retention Rodenticide sample software changes specific standard operating procedures storage system access system users system(s tion validation vendor written procedures