ABSTRACT
Computer-related systems and equipment began to be introduced into wide-scale use in the pharmaceutical industry in the 1970s. At that time they were mainly used to provide real-time process control and monitoring of production processes. Applications were usually bespoke, having been specially developed for the purpose in an ad hoc fashion as required. Later during that decade, computers were adopted as information management systems, based on database engines then available. A common example was their use as primitive electronic batch record systems. Computer systems of that era continued to be based on dedicated hardware such as personal computers (PCs), programmable logic controllers (PLCs), and mainframe computers. As time passed, applications began to make use of newly available Commercial Off-The-Shelf (COTS) software. Despite this increasing use of standard software packages many projects were regularly over budget, late, and-far more seriously-did not fulfill their original user requirements. Improved levels of management acumen and control in this arena were clearly required from both business and regulatory standpoints.
