计算机系统问题报告管理规程
User Problem Reporting Management for
Computerized System
1 目的/Purpose
此规程规定系统日常运行期间与质量无影响问题报告程序。
This document is to define the procedures on the reporting of non-quality impacting problem during routine operation.
2 范围/Scope
2.1 所有GxP计算机系统All GxP computerized system
3 职责/Responsibility
3.1 所有员工All personnel
按照此规程报告系统日常运行期间发生与质量无影响的技术问题。
Report non-quality impacting technical problem occurs during routine operation as defined in this procedure 3.2 技术管理员Technical Administrator
a) 调查问题的根本原因Investigate the root cause of the problem b) 实施修复措施Implement remediation action c) 修复措施实施结束后，放行系统予日常使用。
Release system for operational use upon completion of the remediation actions.
3.3 验证主管Validation Supervisor
a) 如适用，修复措施实施结束后进行确认/验证。
Perform verification/validation after remediation action has been taken, if applicable
4 定义/Definition
对质量有影响的事件：对病人安全、产品质量和数据完整性有影响的非计划性问题。
Quality impacting incident: Unplanned issues that could impact patient safety, product quality and data integrity
5 程序/Procedure
5.1 用户问题（技术）User problem (technical) 5.1.1
硬件问题Hardware problem
发生硬件无法支持系统正常操作事件包括但不仅限于硬盘故障、服务器故障、网络部件故障。
Hardware being unavailable for the normal operation of the system includes but not limited to hard disk breakdown, server breakdown, network component breakdown 5.1.2
软件问题software problem
发生软件无法支持系统正常操作事件包括但不仅限于软件崩溃、病毒袭击。 Software being unavailable for the normal operation of the system includes but not limited to software crashes, virus attack 5.1.3
性能监测异常Exception occurred during performance monitoring
出现性能指标趋势不符合监测基线标准。
Observation of trend not conforming to baseline monitoring criteria 5.1.4
系统访问和安全相关问题System access and security related issues
发现未经授权人员登录系统或系统用户无法登录系统等等。
Occurrence of unauthorized access to the system or user being unable to login to system, etc
5.2 用户问题报告Reporting of user problem 5.2.1 题。
Any person who identifies a problem as listed in section 5.1 should report the
任何人发现章节5.1所描述的问题应即时使用《用户问题报告》报告问
problem using user problem report as defined in “User Problem Report” immediately 5.2.2
但是如果发现的问题对质量有影响则不需要编写用户问题报告而是按照
《偏差管理规程》编写偏差报告
However if the problem discovered is identified as quality impacting incident, no user problem report is necessary and a deviation shall be initiated in accordance with “Deviation Management” 5.2.3
将用户问题报告提交给技术管理员进行调查。
Submit the user problem report to the technical administrator for investigation 5.2.4
如适用，通过电子邮件通知所有系统用户或支持有关该事件。
Inform all system users/support of the problem via email, if applicable 5.2.5
技术管理员接收到用户问题报告后应及时开始问题调查并初步估算解决
问题所需要的时间和资源。
Upon receiving the user problem report, technical administrator shall investigate the problem instantly and provide a preliminary estimate of the amount of time and resources needed to solve the problem 5.2.6
如果无法在三小时内解决问题则必须启动业务连续性计划。
If the problem could not be solved within 3 hours, then the system business continuity plan should be invoked 5.2.7
如果可以在三小时内解决问题则通知用户最新状况而用户则可依据情况
定夺下一步行动。
When it is possible to resolve the problem within 3 hours, inform the users of the situation and users could decide their next course of action 5.2.8
采取修复措施后进行确认/验证，如适用。
Perform remediation action and subsequently verification/validation, if required 5.2.9
确认/验证可以以补充方案形式进行文件记录或者将测试卷附到用户问
题报告后。
Verification/validation can be documented in a protocol addendum or attaching the test script to the user problem report
5.2.10 如适用，放行予日常生产前进行系统健康检查。
Prior to release to production, perform system health check if applicable 5.3 用户问题报告User problem report 5.3.1
描述Description
提供问题简短描述、细节包括问题发生日期、时间系统名称/编号。
Provide a brief description of the problem. Details to include the data, time, the system name/ number where the problem occurs 5.3.2
调查Investigation
5.3.2.1 技术管理员将记录问题根本原因调查细节。
Technical administrator to record the problem root cause investigation details 5.3.2.2 如适用，进行修复措施后必须进行确认/验证则必须在此注明。 If applicable, any remediation action that will require verification/validation shall be specified in this section 5.3.3
修复措施Remediation action
进行修复行动的人员将记录所采取的修复行动并记录相关的确认/验证文档，如适用。
The person performing the remediation to record the remediation action taken and reference the related verification/validation documentation, if applicable 5.4 问题报告编号Numbering of user problem report UPR-TTT-YYYY-001 TTT
： 系统编号（除SYM-外），具体编号见各部门/车间的系统清单。
System number (remove SYM), system number is available in the system inventory of every department/workshop YYYY：
年，四位数。 Year 4 digit
001： 流水号，三位数，从001开始。Sequence number 3 digit beginning with 001
6 参考资料及相关SOP/References and Related SOPs
6.1 ISPE GAMP 5，基于风险基础战略的符合GxP的计算机系统
ISPE GAMP 5 A Risk-Based Approach to Compliant GxP Computerized
System
6.2 偏差管理规程 Deviation Management
7 附录/Appendix
无None
8 附件/Attachment
无None
9 记录/Record
9.1 用户问题报告 User Problem Report
10 颁发部门、分发部门/Issuing Department and Distribution Department
10.1 10.2
颁发部门Issuing Department：质量管理部QA 分发部门Distribution Department：
质量管理部QA、质量控制部Quality Control、生产运营部Production、公共支持部Utilities、物流部Logistics、安全环保部EHS、综合管理部Administration、研发中心R&D Center、销售中心Marketing & Sales、各工厂All plants和各生产车间All workshops.
11 培训要求/Training requirement
培训对象Trainee：全体员工All employees。
12 修订历史/History of Revisions
版本号 Version 第1版 生效日期 Effective Date 年 月 日 更新内容 Description 新建First Issue 变更申请号 DCR No.
18_计算机系统问题报告管理规程
