Process modelling of validation and product lifecycles

This paper briefly describes validation applied to Good Manufacturing practice in the manufacture of drugs and other products, and draws some comparisons with regulatory compliance in the Construction Industry. It describes current work on the eValid project at UMIST where Process Modelling techniques are being used to analyse four business processes and to communicate the results to management. Appropriate techniques for analysis and communication are discussed. Examples are given, with diagrams, of extensions to the existing PISTEP process plant engineering activity model, and also of product and process lifecycle - being developed. Also, a process model of the validation activity is described. The use of these - to define and structure information requirements is discussed. The relevance of this work to standards development activities such as STEP is explained, and possibilities for further generic work are briefly mentioned.