封面图
正文内容
验证阶段完成，需要进一步完善系统的使用、维护和管理相关的SOPs，系统可正式在生产环境下启用。经过验证后启用的计算机化系统和所有相关的文件必须在变更控制和周期性回顾下进行维护，以维持系统的验证状态。系统验证状态的保持既是满足用户需求，也是保证数据安全的必要选择。系统验证状态的保持与配置管理、流程管理、用户管理、容量管理、供应商管理、系统维护、变更管理、事件管理、偏离管理、数据备份、业务持续、灾难恢复及定期审核紧密相关。保持系统的验证状态需要执行以下流程：
After the verification phase is completed, it is necessary to further improve the SOPs related to the use, maintenance and management of the system, and the system can be officially launched in the production environment. The validated computerized system and all relevant documents must be maintained under change control and periodic review to maintain the verification status of the system. The maintenance of system verification status is not only a necessary choice to meet user needs, but also to ensure data security. The maintenance of system verification status is closely related to configuration management, process management, user management, capacity management, supplier management, system maintenance, change management, event management, deviation management, data backup, business continuity, disaster recovery and regular audit. To maintain the verification status of the system, the following processes need to be performed:
（1）变更控制；
(1) Change control;
（2）文件管理；
(2) Document management;
（3）周期性的法规符合性回顾和再验证；
(3) Periodic regulatory compliance review and revalidation;
（4）评估控制及逻辑和物理安全性；
(4) Evaluate control and logical and physical security;
（5）培训；
(5) Training;
（6）备份、保存和恢复。
(6) Backup, save and restore.
4 计算机化系统运行需注意的安全事项
4 Safety Precautions for Computerized System Operation
计算机化系统安全主要涉及以下4个方面：物理安全、逻辑安全、数据的完整性及备份安全。使用计算机化系统的机构首先要有本单位管理层的政策、制定必须执行的标准、执行任务的方法及建议、计算机化系统相关的标准操作规程以及遵从标准所参考的最低安全要求。
Computerized system security mainly involves the following four aspects: physical security, logical security, data integrity and backup security. Organizations using computerized systems should first have their own management policies, formulate standards that must be implemented, methods and suggestions for performing tasks, standard operating procedures related to computerized systems, and comply with the minimum safety requirements referred to in the standards.
系统的变更控制及维护要有相应的团队或委员会向系统所有者（即系统总负责人）负责并报告，做好配置管理、系统相关资产的管理、变更管理、风险管理、防病毒管理及补丁管理。计算机化系统所用的安全程序应能确保硬件、软件和数据不被损坏或者未经授权的修改或丢失。为保证计算机化系统及其数据不会发生未经授权的使用或更改，要避免可能的由于病毒或者其他间谍程序引起的数据损坏。
For the change control and maintenance of the system, a corresponding team or committee shall be responsible for and report to the system owner (i.e., the general person in charge of the system), and do a good job in configuration management, system-related asset management, change management, risk management, anti-virus management and patch management. The security procedures used in the computerized system shall ensure that the hardware, software and data are not damaged or unauthorized modified or lost. In order to ensure that the computerized system and its data will not be used or changed without authorization, it is necessary to avoid possible data damage caused by viruses or other spyware programs.
如果系统发生短期或者长期崩溃，也应采取一定的安全措施以保证数据的完整性。工作人员要有安全意识，机构加强培训工作人员对突发事件的应对、检测及分析事件原因、消除隐患及恢复系统使用的能力。机构还需要制定发展业务连续性规划及注意事项、灾难恢复计划、数据传输、存储及处理的方法、访问控制机制、网络安全等方面的内容，以确保计算机化系统顺利运行及数据的安全性。
In case of short-term or long-term collapse of the system, certain security measures should also be taken to ensure data integrity. The staff should have safety awareness, and the organization should strengthen the ability of training the staff to respond to emergencies, detect and analyze the causes of events, eliminate hidden dangers and restore the use of the system. Organizations also need to develop business continuity plans and precautions, disaster recovery plans, data transmission, storage and processing methods, access control mechanisms, network security and other aspects to ensure the smooth operation of computerized systems and data security.
感谢您的阅读，此文的文章来源：计算机化系统验证公司更多的内容和问题请点击：https://www.fmkgmp.com我们会继续努力的为您提供服务，感谢您的支持！
Thank you for reading. The source of this article is: Computerized System Verification Company. For more information and questions, please click: https://www.fmkgmp.com We will continue to work hard to provide you with services. Thank you for your support!