ABSTRACT
GxP regulations governing the pharmaceutical industry require suppliers of standard software products to be audited by the pharmaceutical manufacturers who use them. Supplier audits are used to verify that the supplier has effectively managed the quality of its product. Standard software may require configuration but should require little or no customization to its executable code to enable its application. Significant customization would suggest that the software product is actually a bespoke development. Standard software is sometimes also referred to as shrink-wrapped software or commercial off-theshelf software. It is not industry practice to conduct audits for established standard software that is widely used, such as operating systems. Supplier audits, however, are necessary if the so-called standard software being used by a pharmaceutical manufacturer has been especially developed for the manufacturer. These Supplier Audits adopt a similar approach to that described in this chapter but with more detailed project audit perspective [1,2]. Supplier audits are also recommended for new releases of standard software that have not been market tested.
