ABSTRACT
Pharmaceutical QC laboratories must work electronically
if they are to survive.
This statement is not made because of regulatory
requirements but simply business pressures facing the
pharmaceutical industry today: profit margins are under
pressure from government pricing; also, delays in
accepting or rejecting raw materials, active ingredients
or finished products costs time and money. As analytical
laboratories are at the end of the production chain any
delay is visible and can magnify the cost of other delays
elsewhere in production. Therefore, any implementation
of a LIMS in a QC laboratory has to provide tangible
business benefits through the elimination of paper
records and the use of electronic signatures with associ-
ated electronic workflows.
