eugmpannex11计算机控制系统+eugmpannex8原辅料和包装材料的取样.pdf

附件 11 COMPUTERISED SYSTEMS 计算机控制系统 Principle 原则 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. 在生产制造系统包括储存、分发和质量控制里的计算机控制系统的采用，并没有改变需要遵守普遍 适用的指南中相关原则的要求。 在一个计算机控制系统取代一个人工操作的地方 , 不应有产品质量 或质量保证方面的降低 . 应慎重考虑由于操作人员参与的减少而造成已有的监控系统有缺失的风险 . Personnel 人员 1. 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. 关键人员与那些涉及计算机系统的人员之间的最密切的合作是十分重要的 . 岗位负责人员应接受关 于他们所负责领域内， 利用电脑进行的系统管理和运用的相关培训。 这包括确保相应的专门技术人 员，在计算化系统的设计、验证、安装和操作等方面的提供协助 . 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