An editorial I authored was just posted on the eyeforpharma website:http://www.eyeforpharma.com/index.asp?news=43996
The article starts:
"Electronic technologies have had a profound influence on the ways people work; even in the life sciences almost everyone uses e-mail and voice mail in their daily jobs, and many use web conferencing, document authoring, websites, etc. Usually these e-technologies were implemented by companies to promote process efficiencies, or even just to ‘keep up’ with other companies. But just as Napster and other file-swapping technologies have challenged standard business models, so are electronic technologies forcing process changes within companies, not necessarily only to achieve benefits, but also to maintain or achieve compliance. (11/10/2004)
As an example, consider the concept of an ‘original document’ which is very common to many structured processes in life sciences companies: in the electronic world there is no such thing as an ‘original’ – there can be any number of exactly equivalent versions that cannot be distinguished by special paper or blue ink signatures as paper originals have traditionally been. Nevertheless, for compliance reasons we need to confidently point to a specific document as being ‘authoritative’; with tightly implemented controls this can be achieved within a company (a “closed system” under 21 CFR Part 11), but then how do we do the same as we exchange documents with partners, regulators and even the public? This article briefly surveys some alternate approaches, including the industry SAFE initiative..."