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Quality Assurance
Good Practice, Regulation, and Law
Volume 11, 2005 - Issue 1
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Original Articles

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

, , &
Pages 5-24 | Published online: 24 Feb 2007
 

ABSTRACT

Electronic recordkeeping is increasingly replacing handwritten 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.

Notice

The U.S. Environmental Protection Agency, through its Office of Research and Development, funded and performed the work described here. This manuscript has been subjected to the EPA's peer and administrative review and has been approved for publication. Opinions expressed are those of the authors and do not reflect the opinions of the EPA. Mention of trade names or commercial products does not constitute endorsement or recommendation for use.

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