ABSTRACT
Biotechnology is providing new and more effective therapies (i.e., biologicals, biopharmaceuticals, and vaccines) for many conditions such as leukemia and H1N1 “swine” flu and is the fastest growing sector in the pharmaceutical industry for new product licenses today. These products are often difficult to make because of their complexity and consequently carry a premium price. This makes them very attractive to pharmaceutical companies wanting to bolster their pipeline of new products. In many organizations, however, there is a steep learning curve to establish the necessary quality standards including those appropriate for computer applications.
