gmp计算机软件系统分类原则,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 si