DB31/T 791-2014 Drug production quality management system information technology specification
DB31/T 791-2014 Drug production quality management system information technology specification
Basic Information
Scope
This standard specifies the basic content of informationized monitoring software for the entire production process of pharmaceutical enterprises, including basic information management, inventory management, procurement management, sales management, process and formula support, quality management, production management, electronic monitoring code management for drugs, organizational structure and personnel management, equipment management, document management, system environment and user interface, system integration, system management, and information system quality assurance.
This standard is applicable to the development, application, and management of informationized monitoring software systems for the entire production quality management of pharmaceutical enterprises.