新版GMP对自动化设备、计算机系统软件的验证要求

　　CSV计算机系统验证

　　与GMP相关的计算机系统均为需要验证的计算机系统。 —般用于控制生产过程，或处理与产品制造、质量控制、质量保证等相关数据的计算机系统均应验证。

　　With GMP relevant the computer system need to validation. Generally, all the systems should be verified , which is used to control the production process, or processing with product manufacturing, quality control, quality assurance and other relevant critical data computer system.

　　1.计算机系统验证计划 主要阐述计划的验证活动、各部门职责以及批准程序。

　　1. Computer system validation plan; state verification activities of plan, the responsibilities of each department and approval procedures.

　　2.计算机系统文件 这些文件至少应有该系统性能描述、如何使用该系统及其相关的技术资料。

　　Computer system files: these files should have description of the system performance at least and how to use the system and its related technical information.

　　3.电子记录和签名 对于那些有电子签名和电子记录的系统，必须有相关文件及资料能证明这些电子的签名或记录是得到授权和可信赖的。

　　Electronic records and signatures; For those systems have electronic signatures and electronic records must have the relevant documents and information to prove that these electronic signature or record is authorized and reliable.

　　4.供应商的评估报告 必须一份关于供应商被如何评估(或审核)的报告，以便对验证活动进行正确评价。

　　Suppliers assessment report : You must have a report on how to assess(or audit) suppliers , so that correctly evaluate the validation activities.

　　5.测试报告文件应能显示计算机平台、应用软件已正确安装和测试，并且测试结果与预期—致，可以信赖并有重复性。

　　The test report files can indicate the computer system platform, application software are properly installed and tested ; the test results in line comply with intended expectation , for which is reliable and repeatable.

　　6.培训: 包括操作和维护的软件安装，程序备份和恢复方法，灾难恢复，系统管理，基本的系统网络故障诊断系统;必须有相应的培训文件和记录

　　Training: Includes the installation of operation and maintenance software ,program backups , disaster recovery , system management , basic system network work ; There shall be associated training documents and records.

　　7.安全:需有相应SOP或安全制度来控制进入该系统。

　　Security: There must be the associated SOP or security measures to monitor the system access. corresponding SOP or security measures to control the operation of the system.

　　8.变更控制:必须有书面的文件