ICH在计算机中的作用,ICH Q7 对计算机化系统的要求

原标题：ICH Q7 对计算机化系统的要求

5.4 Computerized Systems

计算机化系统

5.40 GMP-related computerized systems should be validated. The depth and scope of validation depends on the diversity, complexity, and criticality of the

computerized application.

与 GMP 相关的计算机化系统应当验证。验证的深度和广度取决于计算机应用的差异性、复杂性和关键性。

5.41 Appropriate installation and operational qualifications should demonstrate the suitability of computer hardware and software to perform assigned tasks.

适当的安装确认和操作确认应当能证明计算机硬件和软件适合于执行指定的任务。

5.42 Commercially available software that has been qualified does not require the same level of testing. If an existing system was not validated at time of installation, a retrospective validation could be conducted if appropriate documentation is available.

经证明合格的商用软件不需要进行系统水平的检验。如果现行系统在安装时没有进行验证，有合适的文件证明时可进行回顾性验证。

5.43 Computerized system should have sufficient controls to prevent unauthorized access or changes to data. There should be controls to prevent omissions in data (e.g., system turned off and data not captured). There should be a record of any data change made, the previous entry, who made the change, and when the change was made.

计算机化系统应当有足够的控制，以防止未经许可存取或改动数据。应当有防止数据丢失(如系统关闭而数据未捕获)的控制。任何数据的变更、上一次输入、谁作的变更和什么时候变更都应当有记录。

5.44 Written procedures should be available for the operation and maintenance of computerized system.

应当有计算机化系统操作和维护的书面程序。

5.45 Where critical data are being entered manually, there should be an additional check on the accuracy of the entry. This can be done by a second operator or by the system itself.

手工输入关键性数据时，应当另外检查输入的准确性。这可由第二位操作人员或系统本身来进行。

5.46 Incidents related to computerized system that could affect the quality of intermediates or APIs or the reliability of records or test results should be recorded and investigated.

应当加以记录可能影响中间体或原料药质量、或者记录或测试结果可靠性的与计算机化系统有关的偶发事件，并作调查。

5.47 Changes to computerized system should be made according to a change procedure and should be formally authorized, documented, and tested. Records should be kept of all changes, including modifications and enhancements made to the hardware, software, and any other critical component of the system. These records should demonstrate that the system is maintained in a validated state.

对计算机化系统所作的变更应当按照变更程序进行，并应当经过正式批准、记录成文并作测试。所有变更记录都应当保存，包括对系统的硬件、软件和任何其它关键组件的修改和升级。这些记录应当证明该系统维持在验证过的状态。

5.48 If system breakdowns or failures would result in the permanent loss of records, a back-up system should be provided. A means of ensuring data protection should be established for all computerized system.

如果计算机的故障或失效会导致记录的永久丢失，则应当提供备份系统。所有计算机化的系统都应当有数据保护措施。

5.49 Data can be recorded by a second means in addition to the computer system.

除计算机系统之外，数据可以用第二种方式记录。返回搜狐，查看更多

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