PIC/S《數據完整性指南》（第三稿）中要求對計算機化系統禁用USB設備，如有必要, 應僅為經批準的用途開放端口, 并在使用前正確掃描所有USB設備。不應允許在公司計算機客戶端和承載GxP數據的服務器上使用私人USB設備 (閃存驅動器、相機、智能手機、鍵盤等), 也不應允許公司USB設備在私人計算機上使用。如下：

Restrictions on use of USB devices

使用USB設備的限制

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.

出于系統安全的原因, 應在計算機客戶端和承載GxP關鍵數據的服務器上默認禁用USB 端口。如有必要, 應僅為經批準的用途開放端口, 并在使用前正確掃描所有USB設備。

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.

不應允許在公司計算機客戶端和承載GxP數據的服務器上使用私人USB設備 (閃存驅動器、相機、智能手機、鍵盤等), 也不應允許公司USB設備在私人計算機上使用。

與USB設備相關的缺陷案例：

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.

我們檢查人員發現你們單機儀器（XX HPLC系統，XX氣相系統，以及XX紅外系統）的審計追蹤功能未激活。你們亦無其它機制記錄和監測對所這些儀器所生成的數據所做的變更。你們公司將這些儀器中的電子數據備份至移動硬盤XX。但是，該硬盤并未有密碼保護，并且放置在一個未上鎖的辦公室里一個未上鎖的抽屜中。

——FDA警告信：吉林某藥企

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. 

在檢查期間，一名化驗員從一臺HPLC儀器控制電腦中撥出一個U盤。當我們要求提供這個U盤時，該化驗員帶著U盤離開了房間。在約15分鐘之后，管理人員提供給我們調查人員一個U盤，他們說這就是當時被化驗員帶走的U盤。我們無法知道管理人員所提供的U盤是否正是該名化驗員所撥出的U盤。

——FDA警告信：浙江某藥企