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Implementing and Auditing Electronic Recordkeeping Systems Used in Scientific Research and Development

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Abstract:Electronic recordkeeping is increasingly replacing hadwritten records in the course of "normal business." As this trend continues, it is important that organizations develop and implement electronic recordkeeping policies and procedures. This is especially true for Research and Development organizations because of the potential to transform a discovery into a patent, and at times patent application contests are resolved in litigation. This paper provides a basis for the development, implementation, and subsequent assessment of a Research and Development recordkeeping policy. The approach described in this paper should be tailored by the organization adopting this approach to meet the needs of their organization.
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Citation:Brilis, G. M., J. G. Lyon, J. Worthington, and R. Lysakowski. Implementing and Auditing Electronic Recordkeeping Systems Used in Scientific Research and Development. QUALITY ASSURANCE: GOOD PRACTICE, REGULATION, AND LAW. Taylor & Francis, Inc., Philadelphia, PA, 11:5-24, (2005).
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Contact: Chris Siebert - (702) 798-2234 or siebert.christopher@epa.gov
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Division: Environmental Sciences Division
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Branch: Immediate Office of Division Director
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Product Type: Journal
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Published: 06/14/2005
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Bullet Item Implementing and Auditing Electronic Recordkeeping Systems Used in Scientific Research and Development
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Bullet Item Cross-Cutting QA Issues Involving Geospatial Sciences, Chemistry, Information Management, and Law
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