ABSTRACT
Today it seems that everything has automation hiding in it somewhere! The focus of this chapter on computer validation compliance, however is what we will term the application-based computer-related system (CRS), as opposed to computer-controlled process equipment. Examples of a CRS may include laboratory information management systems (LIMS), supervi-sory control and data acquisition (SCADA) systems, document control sys-tems, calibration data management systems, and any other of the myriad systems that mate a portable software application to commercially available computer hardware. This is different, for example, from a modern waterfor-injection still that employs computer software and hardware but is inex-tricably linked to specialized mechanical process equipment. The validation testing for such equipment is typically focused on the mechanical perfor-mance of the equipment, rather than on the performance of the software itself. Many of the concepts discussed in this chapter (validation plans, speci-fications, etc.), however have analogous counterparts related to equipment validation, and the goal is the same: verification that a system consistently performs its intended function throughout its usable life.
