Can you validate enterprise systems such as SAP R/3?

Enterprise systems now cover a wide range of applications in the pharmaceutical industry. Common systems are MRP II applications such as SAP R/3 or BPCS, laboratory control systems (LIMS) and manufacturing execution systems (MES) such as Flowstream. They often cross traditional functional boundaries. For example, the LIMS that are used in quality assurance testing laboratories also link into the MRP II systems, providing data to allow speedy batch release. We believe that you can validate enterprise systems, and this paper outlines our approach to the validation of enterprise systems. Validation is important for enterprise systems, including those that predominantly address commercial issues, because it is essential to demonstrate control of all the factors that can impact on product quality. It is an obvious regulatory requirement, and also essential to protect the business from the consequences of poor quality standards, e.g. downtime, recalls and litigation. The size and the complexity of the systems involved means that the validation exercise is not in itself a simple issue. For example, there is potential for almost limitless testing of the systems. This paper is based on validation primarily to meet legislative requirements, not to address other types of risk. However, there is no reason why the logical approach suggested could not be applied in other areas, e.g. with financial applications, in order to minimize the potential for loss of control or system failures.