Implementing and auditing electronic recordkeeping systems used in scientific research and development.

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.