The drug monitoring code software system consists of the drug regulatory network platform of the State Food and Drug Administration, enterprise client, electronic key, drug monitoring code implementation application software, and electronic supervision code printing software. Among them, the enterprise client software can be downloaded from the drug electronic supervision network, and the electronic key needs to be applied to the drug regulatory bureau.
The drug monitoring code system implementation application software is designed by drug manufacturers to find drug monitoring code system integrators according to the actual situation of the enterprise. Generally, the content should be included:
(1) Basic information. Product information, plant information, workshop information, production line information, online equipment information, station information, order information management;
(2) Data management. Import of product information data, import of supervision code, export of supervision code, export of association relationship, database;
(3) Production management module;
(4) Exception handling module.
The drug monitoring code hardware system consists of server, printing PC, plane labeling machine, on-site industrial computer, drug monitoring code scanner, bar code printer, etc. In addition, the existing equipment needs to be modified according to the system implementation.
1 unified integrator selection
It is important to choose a system integrator that meets the technical standards of the Electronic Drug Regulatory Network. For example, if a company chooses a system integrator that does not meet the relevant technical standards, the system integrator must first pass the corresponding technical standards. After the enterprise enters the network, it can find a list of system integrators that meet the technical standards in the drug electronic supervision network. After signing the contract with the system integrator, the enterprise must select the corresponding system integrator in the drug electronic supervision network to register and record. The drug electronic supervision network will track and support the packaging line transformation work of the production enterprises according to the filing information.
2 industry internal management
Enterprises should formulate corresponding management systems according to the characteristics and usage requirements of electronic supervision codes. The main contents of the products should include: scanning the electronic supervision code of drugs when the drugs are delivered to the warehouse; reporting the relationship data on time and accurately; on time and accurately Reporting the warehousing data; the method of keeping, using, and reporting the digital certificate: The digital certificate must be kept safely and must be used by a special person. It must not be transferred to others. If it is found to be lost, it must be reported to the drug electronic supervision network operation center in time for the loss reporting; The management method of the supervision code.
3 staffing and training
The production enterprise shall be equipped with at least one computer operator familiar with the basic information of the computer, familiar with the basic operation of the computer and one skilled in the production business, and provide corresponding training for the production line business personnel, warehouse business personnel and information personnel.
The drug monitoring code system implementation application software is designed by drug manufacturers to find drug monitoring code system integrators according to the actual situation of the enterprise. Generally, the content should be included:
(1) Basic information. Product information, plant information, workshop information, production line information, online equipment information, station information, order information management;
(2) Data management. Import of product information data, import of supervision code, export of supervision code, export of association relationship, database;
(3) Production management module;
(4) Exception handling module.
The drug monitoring code hardware system consists of server, printing PC, plane labeling machine, on-site industrial computer, drug monitoring code scanner, bar code printer, etc. In addition, the existing equipment needs to be modified according to the system implementation.
1 unified integrator selection
It is important to choose a system integrator that meets the technical standards of the Electronic Drug Regulatory Network. For example, if a company chooses a system integrator that does not meet the relevant technical standards, the system integrator must first pass the corresponding technical standards. After the enterprise enters the network, it can find a list of system integrators that meet the technical standards in the drug electronic supervision network. After signing the contract with the system integrator, the enterprise must select the corresponding system integrator in the drug electronic supervision network to register and record. The drug electronic supervision network will track and support the packaging line transformation work of the production enterprises according to the filing information.
2 industry internal management
Enterprises should formulate corresponding management systems according to the characteristics and usage requirements of electronic supervision codes. The main contents of the products should include: scanning the electronic supervision code of drugs when the drugs are delivered to the warehouse; reporting the relationship data on time and accurately; on time and accurately Reporting the warehousing data; the method of keeping, using, and reporting the digital certificate: The digital certificate must be kept safely and must be used by a special person. It must not be transferred to others. If it is found to be lost, it must be reported to the drug electronic supervision network operation center in time for the loss reporting; The management method of the supervision code.
3 staffing and training
The production enterprise shall be equipped with at least one computer operator familiar with the basic information of the computer, familiar with the basic operation of the computer and one skilled in the production business, and provide corresponding training for the production line business personnel, warehouse business personnel and information personnel.
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