计算机系统回顾规程
Periodic Review of Computerized System
1 目的/Purpose
此规程规定确认GxP计算机系统在运行阶段期间保持验证状态并适合预期使用目的而需要进行的回顾。
This document is to define the procedures on periodic review to verify that the GxP computerized system remains validated and fit for its intended use throughout its operational life.
2 范围/Scope
2.1 所有经过验证并在运行条件下的GxP计算机 All validated GxP computerized system in operation
3 职责/Responsibilities
3.1 系统用户System user
a）进行定期回顾Perform periodic review
b) 响应定期回顾的发现Respond to periodic review finding c) 审核回顾报告Review periodic review reports
d) 实施纠正措施，如有Implement corrective action, if any 3.2 主题专家Subject Matter Expert a) 进行定期回顾Perform periodic review
b) 提议和实施纠正措施，如有Propose and implement corrective action, if any 3.3 验证主管Validation Supervisor a) 进行定期回顾并编写回顾报告
Perform periodic review including preparation of periodic review report b) 审核提议的纠正措施，如有Review corrective actions proposed, if any
3.4 质量负责人Head of Quality
a) 批准回顾报告Approve periodic review report
b) 批准纠正措施，如有Approve corrective actions proposed, if any
4 定义/Definition
EU： 欧盟European Union
GAMP：良好的自动化生产实践指南Good Automation Manufacturing Practice GMP： 药品生产管理规范Good Manufacturing Practice PIC/S：国际医药品稽查协约组织
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
QM：质量管理部Quality Management
SOP：标准操作规程Standard Operating Procedure
5 程序/Procedure
5.1 定期回顾时机和排期Timing and scheduling of periodic review 5.1.1 频率。
Determine the frequency of review based on system impact, complexity and novelty upon the completion of verification phase of a computerized system 5.1.2
至少每年对直接影响系统进行回顾一次；至少每三年对间接影响系统进在计算机系统确认阶段结束时根据系统影响、复杂性和新颖性确定回顾
行回顾一次。
For direct impact system, perform periodic review at least once every year and once every three years for indirect impact system 5.1.3
新的计算机系统在各自的验证总结报告记录计划的回顾时间而接下来的
回顾计划则记录在定期评估报告内
Review schedule shall be documented in the respective computerized system validation summary report for a new system and subsequently in the periodic evaluation report
5.1.4 除此，以下的事件也将触发回顾：
In addition, additional review may be conducted when the following events occur:
5.1.4.1 功能、工艺或法规发生改变
Change control pertaining to functional change, or changes of process or regulations
5.1.4.2 之前评估报告计划的回顾或实施纠正措施后考察其功效而设计的回顾 Planned review as defined in the previous evaluation reports or after the implementation of corrective action to verify the effectiveness of the corrective action 5.1.5
计算机系统（如工艺设备/系统的可编程逻辑控制器或其他智能处理器）
已作为设备或系统的一部分可以与设备或系统同时进行回顾
For computerized systems such as programmable logic controllers(PLC) or other
intelligent
processers that
are
components
of
processing
equipment/system, periodic review may be incorporated into the periodic evaluation performed for the equipment/system 5.2 回顾准备Preparation for review 5.2.1
准备需要回顾的文件。需要回顾的文件不仅限于：
Prepare documents to be reviewed. Documents subjected to periodic review includes but not limited to
5.2.1.1 所有规格文件如用户需求规格、功能说明书、设计说明书和现行版验证总结报告
All the specification documents ie user requirement specification, functional specification, design specification and the last validation summary report
16_计算机系统回顾规程
