Firstly

the authors took pharmaceutical production enterprises as an example to discuss the definition and requirements of intelligent file management system

and then combined with the domestic and international status of good manufacture practices(GMP) inspection defects in the pharmaceutical industry and the requirements of data integrity

the construction idea of intelligent file system was investigated based on the 4W(who

when

where

what) attribute of data.This paper also showed the characteristics of this system with searching and logical operation functions through the three designed examples.Finally

the advantages and implementation difficulties of the system were foreseen.The system will benefit the factory under the background of pharmaceutical 4.0 to achieve efficient and convenient use of all kinds of documents for information retrieval and logic operations

it will promote the drug research and registration work to be more scientific and systematic

but also be conducive to the international standard input and the establishment of pharmaceutical core technology platform.