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在制药行业GMP实施过程中,记录管理是GMP文件管理中重要内容之一。随着计算机化系统的广泛使用和网络技术的普及,越来越多的制药企业在GMP管理过程中使用了ERP(Enterprise Resource Planning,企业资源计划),这就使得电子记录和电子签名的规范管理显得特别重要,直接关系到制药企业实施GMP的效果和质量管理体系的运作效率。对电子记录的管理要求,我国现行版GMP尚未有明确规定,WHO GMP15.9条款提出“可使用电子数据处理系
In the GMP implementation process in the pharmaceutical industry, record management is one of the important contents of GMP document management. With the widespread use of computerized systems and the popularization of network technologies, more and more pharmaceutical companies use ERP (Enterprise Resource Planning) in the GMP management process, which makes the standard management of electronic records and electronic signatures It is particularly important, which is directly related to the effectiveness of the implementation of GMP by pharmaceutical companies and the operational efficiency of the quality management system. The management requirements of electronic records, the current version of GMP in our country has not yet been clearly defined, WHO GMP15.9 clause proposed ”Electronic Data Processing Department