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Preface Capturing and reporting data in the electronic age has become a more sophisticated process during the past decade. The magnitude of data that must be collected, correlated, stored and retrieved is continuing to increase exponentially as more and more data are generated on a global landscape. Regulatory oversight of data capturing and handling, and the ability to accurately and quickly store and retrieve these data have become more demanding processes as well. In earlier times, all data were collected, interpreted and stored in some type of paper format. Instrument printouts, as well as calculation sheets, involved recording on a non-electronic medium. Today, most recording devices incorporate some type of electronic capturing equipment. This book is based upon presentations given during the Division of Agrochemical Symposium and Workshop entitled "Capturing and Reporting Data in the Electronic Age". The symposium and workshop were part of the 220^ American Chemical Society (ACS) National Meeting in Washington, D.C., August 20-24, 2000. From the more than 34 papers presented at this symposium, contributing authors prepared the following chapters as a summary. As we continue to develop more sophisticated, efficient and secure means of data capture, reporting and storage, we must try to keep the process as simple as possible for the end-user. The end-user's are at various stages in the data process and will include those who create the data, those who interpret the data, those who report the data, those who use the data for decision making and those who may need to use the data in the future. This volume will be of interest to anyone who is involved or anticipates becoming involved in electronic data collection, interpretation or storage. It is a highly useful reference to those individuals who are regulating or are regulated by government or other
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auditing authorities. The concepts and principals given in this text are applicable to a variety of disciplines within the scientific community. We hope that this volume will provide a basis for additional thought and interaction on the important subject of electronic data for the new millennium.
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Acknowledgments We thank the participants in the symposium and the authors and contributors to this book. Without their interest, enthusiam and efforts, this book would not have been possible. We thank the ACS Division of Agrochemicals for the organizational and financial support it provided for the symposium and shortcourse. In addition, we thank the symposium sponsors for their continuing financial support of the Division of Agrochemicals and all of our technical symposia: The ACS Industry Relations Committee; Cerexagri, Inc. (a wholly-owned subsidiary of ATOFINA Chemicals, Inc.); E.I. DuPont de Nemours; and Syngenta Crop Protection (formerly Novartis Crop Protection).
Willa Garner Manager, Quality Assurance TherImmune Research Corporation 620 Professional Drive Gaithersburg, MD 20879
Rodney M. Bennett Cerexagri, Inc. 900 First Avenue King of Prussia, PA 19406
Markus Jensen Jensen Agricultural Consultants 565 Petite Prairie Road Washington, L A 70589
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Acronyms AA ACES ACPA ADEQ ANDAs ANSI ASC ATWEED BPPD CA CADDY CBER CBI CDER CDX CFR cGMP COTS CRO CROMERRR CSF CWS DACO DAS DERs DMFs ECPA EDDE EDI eFTN
Application Administrator Access Certificates for Electronic Services American Crop Protection Association Arizona Department of Environmental Quality Abbreviated New Drug Applications American National Standards Institute Accredited Standards Committee American Toxicology Work Group on Electronics Exchange of Data Biological and Pollution Prevention Division Certificate Authority Computer-Aided Dossier and Data Supply Center for Biologies Evaluation and Research Confidential Business Information Center for Drug Evaluation and Research Central Data Exchange Code of Federal Regulations Current Good Manufacturing Practice Commercial Off the Shelf Contract Research Organization Cross-Media Electronics Reporting and RecordKeeping Rule Confidential Statement of Formulas Community Water Systems Data Code Data Acquisition System Data Evaluation Records Drug Master Files European Crop Protection Association Electronic Dossier Delivery and Evaluation Electronic Data Interchange Electronic Field Trial Notebook xiii
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EIEID ERR ESTRI
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EU FESMCC FFDCA FI FIFRA FIPS FOIA FQPA FR FRFA FTP GALP GCPF GLP GLPS GPEA GRN GSA HED ICH ICR IEEE IIS INDs IQ IRFA ISO IT LAN LIMS LOD LOQ MaxLIP MRID
Electronics Information Exchange and Interaction Organization Electronic Reporting/Record-Keeping Electronic Standards for the Transmission of Regulatory Information European Union Federal Electronic Data Interchange Standards Management Coordinating Committee Federal Food, Drug, and Cosmetic Act Field Investigator Federal Insecticide, Fungicides, and Rodenticide Act Federal Information Processing Standard Freedom of Information Act Food Quality Protection Act Federal Register Final Regulatory Flexibility Analysis File Transfer Protocol Good Automated Laboratory Practices Global Crop Protection Federation Good Laboratory Practices Good Laboratory Practice Standards Government Paperwork Elimination Act Guideline Reference Number General Service Administration Health Effects Division International Committee for Harmonization Information Collection Request Institute of Electrical and Electronics Engineers, Inc. Internet Information Server Investigated New Drug Applications Installation Qualification Initial Regulatory Flexibility Analysis International Organisation of Standardisation Information Technology Local Area Network Laboratory Information Management System Level of Detection Limit of Quantitation Maximum Likelihood Imputation Procedure Master Record Identification Number xiv
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MSDS MTS NACA NAFTA NARA NAWQA NDA NGA NIST NPDES NTTAA NTWEED 0+M OCR OECD OEI OMB OPMBSTF OPP OPPTS OQ PAI PDF PDP PFI PhRMA PIN PKI PMA PMRA PQ PR PRA PWSS QA QAP
Materials Safety Data Sheet Microsoft Transaction Server National Agricultural Chemicals Association North American Free Trade Agreement National Archives and Records Administration National Water Quality Assessment New Drug Application National Governors' Association National Institute of Standards and Technology National Pollutant Discharge Elimination System National Technology Transfer and Advancement Act National Toxicology Work Group on Electronics Exchange of Data Operation and Maintenance Optical Character Recognition Organization for Economic Cooperation and Development Office of Environmental Information Office of Management and Budget Organophosphate Market Basket Survey Task Force Office of Pesticide Programs Office of Pollution Prevention and Toxics Operational Qualification Pure Active Ingredient Portable Document Format Pesticide Data Program Principal Field Investigator Pharmaceutical Research and Manufacturers of America Personal Identification Number Public Key Infrastructure Project Management Assistance Pest Management Regulatory Agency Performance Qualification Pesticide Registration Paperwork Reduction Act Pure Water Supply System Quality Assurance Quality Assurance Plan
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QAU RAC RED RFA RTF SDD SDLC SEES SEP SOP SRRD SRS SS STARR TCA TCA TGAI TNRCC TRI TSCA TWG UMRA USDA USEPA USFDA USGS VAN WAP
Quality Assurance Unit Reliability Analysis Center Reregistration Eligibility Document Regulatory Flexibility Act Rich Text Format Software Design Description Software Development Life Cycle State Electronics Commerce/Electronics Data Interchange Steering Committee Standard Evaluation Procedures Standard Operating Procedures Special Review and Registration Division System Requirement Specification System Suitability Sample Tracking and Analytical Results Reporting Terms and Conditions Agreement Trace Confirmation Analysis Technical Grade Active Ingredient Texas Natural Resources Conservation Commission Toxic Release Inventory Toxic Substances Control Act Technical Working Group Unfunded Mandates Reform Act U.S. Department of Agriculture U.S. Environmental Protection Agency U.S. Food and Drug Administration U.S. Geological Survey Value-Added Network Wireless Application Protocol
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