In 1982, Taiwan enacted and implemented GMP (Good Manufacturing Practice) regulation to assist the development of domestic biotechnology industry in order to connect with the world. However, GMP didn’t offer the definite way of software validation. To assist enterprises to pass customers audit and review smoothly, it is very important to develop our validation method and generate related documents for Biotechnology Industry. The purpose of this research is to establish a software validation model and generate related documents. This thesis is based on the principles of GAMP5 to establish the validation model and generate related documents. And validate the execution outcome via the audit of customers. We can get a feasibility method on the software validation in the biotechnology industry and develop the own validation model.