欧盟GMP中的计算机系统验证.docVIP

欧盟GMP——计算机系统 附录11： COMPUTERISED SYSTEMS 计算机系统 Principle The introduction of computerised systems into systems of manufacturing, including storage, distribution and quality control does not alter the need to observe the relevant principles given elsewhere in the Guide. Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality or quality assurance. Consideration should be given to the risk of losing aspects of the previous system which could result from reducing the involvement of operators. 在生产系统中，包括仓储、发放和质量控制中，所应用到的计算机系统，并不意味着因此可以改变本法规内其他条款下所给出的相应原则。只要是由计算机系统代替人工操作的地方，都应当不会因此降低对产品质量或质量保证的要求。应当考虑到，减少生产人员的参与而可能带来前一个系统（有人员参与操作的系统）的某方面的损失的风险。 Personnel 人员 It is essential that there is the closest co-operation between key personnel and those involved with computer systems. Persons in responsible positions should have the appropriate training for the management and use of systems within their field of responsibility which utilises computers. This should include ensuring that appropriate expertise is available and used to provide advice on aspects of design, validation, installation and operation of computerised system. 主要人员与参与计算机工作的人员之间的紧密合作是必须的。管理人员，若其工作领域需要使用到计算机系统，则应当接受合理管理和使用计算机系统的培训。这样的话，可以确保每个人接受并使用专业的计算机知识，并就计算机系统的设计、严整、安装和操作提供个人的建议。 Validation 验证 2. The extent of validation necessary will depend on a number of factors including the use to which the system is to be put, whether the validation is to be prospective or retrospective and whether or not novel elements are incorporated. Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying. 计算机系统验证的范围将根据一系列的因素来决定，包括在哪一个系统中使用的计算机，是否进行展望性验证还是回顾性验证，是否要将一些未知因素包含进计算机系统的验证等。验证应当被认为是计算机系统“生命循环”中的一个部分。这个“循环”包括企划、定标准、编程、测试、试运行、文档管理、操作、监控和更换等各个阶段。 System 系统 3. Attention should be paid to the siti