java怎么实现子系统免登录_如果旧有系统没有审计追踪或不能实现用户“用户登录”怎么办？...

欢迎关注药事云端，了解国内外药事法规和技术趋势 译文by Thomas Tang

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问题陈述：如果旧有系统没有审计追踪或不能实现“用户登录”怎么办？ 首先，从欧盟GMP指南附录11可以推断出，在计算机化系统中应该有与GMP相关数据及其修改相关的审计追踪。如果在采购系统的时候尚未具备该功能，首先应该核查该系统是否更新了审计的追踪功能。如果情况并非如此，则应该实施合适的替代解决方案。欧盟GMP附录11并没有对该替代解决方案的特征进行描述。

可行的方案：

一种可能就是使用手写的审计追踪台账。该替代解决方案也是由PIC/S文件PI 041《关于规范GMP/GDP环境中数据管理和完整性的良好实践》(GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATEDGMP/GDP ENVIRONMENTS)所提议的。 【后台回复关键词：PI 041，即可获得该份指南的中英文双语翻译件】 9.4 关于计算机化系统的审计追踪： 如果不存在电子审计追踪系统，则在获得完全实现审计追踪功能的系统(集成系统或使用经过验证的界面的独立审计软件)之前，使用基于纸质的记录来证明对数据的更改是可以接受的。如果能实现与集成审计追踪的等效性(比如PIC/S GMP指南附录11中所描述的类型)，则这些混合系统是被允许的。 来源： PIC/SPI 041

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原文如下：

How to handle Legacy Systems if no Audit Trail is available or a "User Login" is not possible?

Problem statement: How to handle Legacy Systems if no audit trail is available or a "user login" is not possible?

First of all, it can be deduced from the contents of the EU GMP Guidelines Annex 11 that an audit trail in connection with GMP-relevant data and their modification should be available in a computerised system. If this functionality was not yet available at the time the system was purchased, it should first be checked whether an update with the audit trail functionality is now available for this system. If this is not the case, an appropriate alternative should be introduced. EU GMP Annex 11 does not describe what this alternative should look like.

Possible solution:

One possibility would be to use handwritten audit trail logbooks. This alternative is also proposed by the PIC/S document PI 041 GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS:9.4 Audit trails for computerised systems:
If no electronic audit trail system exists a paper based record to demonstrate changes to data may be acceptable until a fully audit trailed (integrated system or independent audit software using a validated interface) system becomes available. These hybrid systems are permitted, where they achieve equivalence to integrated audit trail, such as described in Annex 11 of the PIC/S GMP Guide.

Source: PIC/S PI 041

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