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9780841237841

Capturing and Reporting Electronic Data

by ; ;
  • ISBN13:

    9780841237841

  • ISBN10:

    0841237840

  • Format: Hardcover
  • Copyright: 2002-08-29
  • Publisher: American Chemical Society

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Summary

This volume reviews current data collection systems, examines unique approaches to data collection and storage, and provides the latest information on regulatory issues on data capture, storage, and reporting.

Table of Contents

Preface xi
Acronyms xiii
Introduction to Capturing and Reporting Data in the Electronic Age
1(4)
Kendy L. Keatley
Managing Electronic Standard Operating Procedures, Protocols, and Protocol Amendments to Good Laboratory Practice Requirements
5(8)
Jane E. Goeke
Combination of Old-Fashioned Values and Electronic Reporting Systems: Good Laboratory Practice Trial Reporting Marriage for the New Millennium
13(5)
W. H. Palmer
Development of Advantage™ eFTN: A Good Laboratory Practice Field Data Capture System
18(10)
Ron Thompson
Ted Paczek
Dudley Dabbs
Building the Agrochemical Regulatory Compliance Pipleine with Astrix e-Compliance Architecture
28(6)
Richard P. Albert
Electronic Field Data Perspective
34(6)
Kenneth A. Ludwig
Robert Hoag
Electronic Data Collection from the Study Director's Viewpoint
40(4)
S. Scott Brady
Auditing Electronic Field Data
44(10)
Renee J. Daniel
Future of Electronic Good Laboratory Practice Study Management Is Now
54(12)
Fate Thompson
Tommy Willard
Carla Wells
Automated Data Collection in the Laboratory Using the Chromeleon™ System
66(9)
William H. Harned
User Testing Strategy for Millennium32 Chromatography Software Validation
75(4)
Timothy J. Stachoviak
Auditing Electronically Captured Analytical Chemistry Data
79(7)
Mary E. Lynn
Good Laboratory Practice Considerations for Electronic Records
86(12)
Kendy L. Keatley
Metrology: A Tool and Approach to Ensure Data Quality
98(11)
Gail E. Schneiders
John C. Brown
Joseph Manalo
Documentation Requirements for the Design of Good Laboratory Practice Software
109(8)
Robert D. Walla
Computer Validation in a Regulatory Environment
117(7)
Ann M. Speaker
Sharon M. McKilligin
Electronic Data Archiving: Ensuring Accessibility, Durability, and Usability
124(9)
Edward J. McDevitt
A New Order of Things: Electronic Pesticide Submissions: The Promise Is Efficiency
133(6)
William N. Casey
Benefits of Electronic Data Submissions: An Industry Perspective
139(13)
Thomas J. Gilding
Food Quality Protection Act of 1996: A New Challenge for Data Generation and Submission
152(7)
W. T. Beidler
L. D. Bray
Electronic State Submissions
159(5)
Charles H. Koopmann
Electronic Pesticide Labeling: Creation, Submission, Review, and Dissemination
164(10)
Thomas C. Harris
Proposed Revisions to Product Chemistry Data Requirements for Registration of Pesticide Chemicals
174(14)
Sami Malak
Deborah McCall
Electronic Data Submission: Pilot Efforts in the Office of Pesticide Programs, U.S. Environmental Protection Agency
188(10)
Kathryn S. Bouve
Electronic Data Submission in the Environmental Protection Agency Office of Pesticide Programs: Supplemental Files
198(11)
Susan V. Hummel
Current State of Electronic Submissions in Europe
209(7)
Steven C. Dobson
Pest Management Regulatory Agency Experiences: Electronic Submissions
216(4)
Carmen Krogh
Electronic Data Submissions for the Environmental Protection Agency and Pest Management Regulatory Agency: Zoxamide Fungicide
220(9)
Janet Ollinger
Paul H. Reibach
Scott Swidersky
The Legal and Policy Framework for Electronic Reporting of Environmental Compliance Reports: Challenges of E-Government: Maintaining Effective Stewardship of the Environment
229(12)
M. Evi Huffer
Establishing the Groundwork for FIFRA/TSCA Reporting under Electronic Submissions, Signatures, and Record-Keeping
241(12)
Francisca E. Liem
Mark J. Lehr
Robert L. Cypher
Considerations for Data Collection Systems
253(11)
Rodney M. Bennett
Appendix Establishment of Electronic Reporting: Electronic Records: Proposed Rule 264(86)
Indexes
Author Index
349(1)
Subject Index
350

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