Electronic signatures in the pharmaceutical industry – wider issues dominate over the technical and practical?
| Pages | 35-48 |
| Published date | 01 April 2000 |
| Date | 01 April 2000 |
| DOI | https://doi.org/10.1108/EUM0000000007255 |
| Author | James Whitman |
| Subject Matter | Information & knowledge management |
Electronic signatures in the
pharmaceutical industry –
wider issues dominate over
the technical and practical?
JAMES WHITMAN
Abstract
This article explores the relationship between the use of electronic signatures and
governance within the pharmaceutical industry. The concept of governance and
the use of research to explore the operation of processes of regulation and gov-
ernment intervention remains largely absent in the records management litera-
ture and further exploration, through additional original research, presents
opportunities to develop records management theory and knowledge of records
management practice
Introduction
This article is based upon work completed as part of an MSc disserta-
tion1that explored the relationship between the use of digital/electronic
signatures and governance within the pharmaceutical industry. An earli-
er
Records Management Bulletin article by Caroline Smith2, stimulated
my own interest in exploring how signature technology can be used with-
in the management of digital records. The impetus for both derived from
the US Food and Drugs Administration (FDA), who published guide-
lines in early 1997,3for the use of electronic signatures by pharmaceuti-
cal companies when making electronic submissions to license products
for use in the United States.
We are all becoming familiar with the challenges that the rapid growth in
digital technologies have created for records management. The pharma-
ceutical industry appears to present a particularly dynamic location for
the development of new approaches and the exploration of relationships
Records Management Journal, vol. 10, no. 1, April 2000, pp. 35–48
Records Management Journal, Vol. 10, No. 1, April 2000
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