| 摘要 |
PROBLEM TO BE SOLVED: To provide a validation method used for verification work when building a pharmaceutical manufacturing plant and capable of efficiently implementing evaluation for eligibility in operation in a short period of time.SOLUTION: The validation method uses a computer provided with a plant simulator, a sequence simulator and a connection program for mutually sending and receiving data between them. In this case the validation method includes: a step (S1) for reading a specification; a step (S2) for reading a sequence program; a step (S3) for building a virtual plant in the plant simulator; a step (S4) for driving the virtual plant based on the sequence program by sending a command to the plant simulator from the sequence simulator through a connection program; a calculation step (S5) for calculating a parameter during operation of the virtual plant; and a determination step (S6) for determining whether the sequence program and the virtual plant are eligible or ineligible by implementing an evaluation for eligibility in operation. |
