Abstract:

 Vaccine safety is crucial for national public health and social well-being. Production and testing data， as core elements of the pharmaceutical quality management system， serve as the cornerstone for ensuring drug quality. To strengthen vaccine regulation， advance the digital transformation of vaccine manufacturers， and promote high-quality development within the industry， the Center for Information and the Center for Food and Drug Inspection of the National Medical Products Administration （NMPA） jointly issued the Technical Guidelines for Electronic Records of Vaccine Production and Testing （Trial） in June 2022， which provide technical direction for vaccine manufacturers in implementing electronic recording and digital management of production and testing processes， and has been formally implemented for over three years. This study takes the vaccine manufacturers in China as the research objects to analyze the implementation pathways for their digital transformation and upgrading. Through investigative research， this study systematically reviews the current status of informatization construction and operational practices within these enterprises. Aligned with digital transformation trends， it identifies existing challenges in this process. Subsequently， the study proposes optimization strategies for digital transformation of vaccine manufacturing enterprises to achieve full life cycle quality management， and to provide reference for enterprises in planning and refining their digital transformation development roadmaps. The transition to digital-enabled and data-driven operations is expected to elevate quality management systems beyond mere compliance， driving the vaccine industry into high-quality development.

Key words:  , Vaccine production； , Digital transformation； , Data value； , Drug administration