PIC/S《数据完整性指南》（第三稿）中要求对计算机化系统禁用USB设备，如有必要, 应仅为经批准的用途开放端口, 并在使用前正确扫描所有USB设备。不应允许在公司计算机客户端和承载GxP数据的服务器上使用私人USB设备 (闪存驱动器、相机、智能手机、键盘等), 也不应允许公司USB设备在私人计算机上使用。如下：

 

Restrictions on use of USB devices

 

使用USB设备的限制

 

For reasons ofsystem security, USBports should be default disabled oncomputer clients and servers hostingGxP critical data. If necessary, portsshould only be opened for approvedpurposes and all USB devices shouldbe properlyscanned before use.

 

出于系统安全的原因, 应在计算机客户端和承载GxP关键数据的服务器上默认禁用USB 端口。如有必要, 应仅为经批准的用途开放端口, 并在使用前正确扫描所有USB设备。

 

The use of privateUSB devices (flash drives, cameras, smart phones,keyboards etc) on company computerclients and servers hosting GxP data, orthe use of company USB devices onprivate computers, should not beallowed.

 

不应允许在公司计算机客户端和承载GxP数据的服务器上使用私人USB设备 (闪存驱动器、相机、智能手机、键盘等), 也不应允许公司USB设备在私人计算机上使用。

 

与USB设备相关的缺陷案例：

 

Our investigator found that audit trails in your standalone instruments ((b)(4) high-performance liquid chromatography systems, (b)(4) gas chromatography systems, and (b)(4) infrared radiation system) were not enabled. You also did not have other mechanisms for recording and monitoring any changes to data generated on these instruments. Your firm backed up electronic data from these instruments to a portable drive (b)(4). However, the drive was not password-protected, and itwas stored in an unlocked drawer in an unlocked office.

我们检查人员发现你们单机仪器（XX HPLC系统，XX气相系统，以及XX红外系统）的审计追踪功能未激活。你们亦无其它机制记录和监测对所这些仪器所生成的数据所做的变更。你们公司将这些仪器中的电子数据备份至移动硬盘XX。但是，该硬盘并未有密码保护，并且放置在一个未上锁的办公室里一个未上锁的抽屉中。

 

——FDA警告信：吉林某药企

 

During the inspection, an analyst removed a USB thumb drive from a computer controlling an HPLC. When asked to provide the drive, the analyst insteadexited the room with the thumb drive. After approximately 15 minutes,management provided our investigator with what they asserted was the USB thumbdrive in question. It is impossible to know whether management providedthe same USB thumb drive that the analyst had removed. 

在检查期间，一名化验员从一台HPLC仪器控制电脑中拨出一个U盘。当我们要求提供这个U盘时，该化验员带着U盘离开了房间。在约15分钟之后，管理人员提供给我们调查人员一个U盘，他们说这就是当时被化验员带走的U盘。我们无法知道管理人员所提供的U盘是否正是该名化验员所拨出的U盘。

 

——FDA警告信：浙江某药企

来源：GMP办公室

关键词： USB