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New GSP Drug information management on My Opinion
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New GSP Drug information management on My Opinion
Food and Drug Administration recently released a new version of ‘Drug Quality Control Standards’ GSP, will be held June 1, 2013 formally implemented, and set up a three-year transition period after the deadline to 2016, still fails to meet the newly revised on drugs GSP requirements of the enterprise, will be based on ‘Drug Administration Law’ the relevant provisions of the cease its pharmaceuticals business activities. New GSP for pharmaceutical distribution enterprise information management, cold chain management and personnel requirements for hardware and software have increased the number of new regulations, the original provisions have also done a lot of adjustments. Information management aspects of the drug, the new GSP made many new regulations, mainly in adding electronic monitoring of drugs, as well as information systems put forward new requirements. Related enterprises should establish specific requirements including LANs, information platform, data consisting of a computer system in order to meet the conditions for implementation of electronic monitoring, and computer facilities management, network environment, database and application software functional requirements have been focused on rules enabling regulatory improve and facilitate the implementation process more retroactively. For drugs in circulation enterprises to implement electronic monitoring system establishment, and the corresponding network building and information system construction, for the current pharmaceutical distribution companies, whether hardware or software problems are not too difficult. From the new GSP About Drug information management requirements, the core content we can understand, the whole system of drug distribution for the electronic monitoring code as a platform for information system construction. The following is our current implementation of electronic monitoring code style: Dr
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