CSV盘算机系统验证 - 上海冠邑信息技巧有限公司

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CSV盘算机系统验证
  • 【产品名称】CSV盘算机系统验证
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  • 【产品价格】面议
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详细阐明

  CSV盘算机系统验证
  与GMP相干的盘算机系统均为需要验证的盘算机系统••。  —般用于把持生产过程,或处理与产品制作¶••⊿质量把持¶••⊿质量保证等相干数据的盘算机系统均应验证••。
  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.盘算机系统验证打算 重要论述打算的验证运动¶••⊿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.盘算机系统文件  这些文件至少应有该系统性能描写¶••⊿如何应用该系统及其相干的技巧材料••。
  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.电子记载和签名  对于那些有电子签名和电子记载的系统,必须有相干文件及材料能证明这些电子的签名或记载是得到授权和可信任的••。
  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.供给商的评估报告  必须一份关于供给商被如何评估(或审核)的报告,以便对验证运动进行正确评价••。
  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盘算机平台¶••⊿利用软件已正确安装和测试,并且测试成果与预期—致,可以信任并有重复性••。
  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: 包含操作和掩护的软件安装,程序备份和恢复方法,灾害恢复,系统管理,基础的系统网络故障诊断系统;必须有相应的培训文件和记载
  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或安全制度来把持进入该系统••。
  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.变更把持:必须有书面的文件来把持系统的任何变更,以保证该系统始终保持在验证过的状态••。
  Change Control: There must be written documents to control any changes of the system ; ensure that the system is always in a validated state.

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