Restrictions on use of USB devices

使用USB設(shè)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(tǒng)安全的原因, 應(yīng)在計(jì)算機(jī)客戶端和承載GxP關(guān)鍵數(shù)據(jù)的服務(wù)器上默認(rèn)禁用USB 端口。如有必要, 應(yīng)僅為經(jīng)批準(zhǔn)的用途開(kāi)放端口, 并在使用前正確掃描所有USB設(shè)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(yīng)允許在公司計(jì)算機(jī)客戶端和承載GxP數(shù)據(jù)的服務(wù)器上使用私人USB設(shè)備 (閃存驅(qū)動(dòng)器、相機(jī)、智能手機(jī)、鍵盤等), 也不應(yīng)允許公司USB設(shè)備在私人計(jì)算機(jī)上使用。

 

與USB設(shè)備相關(guān)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(fā)現(xiàn)你們單機(jī)儀器（XX HPLC系統(tǒng)，XX氣相系統(tǒng)，以及XX紅外系統(tǒng)）的審計(jì)追蹤功能未激活。你們亦無(wú)其它機(jī)制記錄和監(jiān)測(cè)對(duì)所這些儀器所生成的數(shù)據(jù)所做的變更。你們公司將這些儀器中的電子數(shù)據(jù)備份至移動(dòng)硬盤XX。但是，該硬盤并未有密碼保護(hù)，并且放置在一個(gè)未上鎖的辦公室里一個(gè)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(yàn)員從一臺(tái)HPLC儀器控制電腦中撥出一個(gè)U盤。當(dāng)我們要求提供這個(gè)U盤時(shí)，該化驗(yàn)員帶著U盤離開(kāi)了房間。在約15分鐘之后，管理人員提供給我們調(diào)查人員一個(gè)U盤，他們說(shuō)這就是當(dāng)時(shí)被化驗(yàn)員帶走的U盤。我們無(wú)法知道管理人員所提供的U盤是否正是該名化驗(yàn)員所撥出的U盤。

——FDA警告信：浙江某藥企