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序號(hào)

報(bào)告內(nèi)容

編譯

Data processing equipment

數(shù)據(jù)處理設(shè)備

1

An inventory of computerised systems was available.

有一份計(jì)算機(jī)化系統(tǒng)的清單。

2

Electronic data was backed up at appropriate  regular intervals in accordance with SOP titled as “The guidelines for  creating backup copies of electronic data”. Software systems associated to  the instruments were connected to a backup program. Additionally, data was  regularly saved on an external hard drive, under appropriate supervision.  Another backup copy was prepared once a year.

電子數(shù)據(jù)按照名為“電子數(shù)據(jù)備份指南”的SOP，按適當(dāng)?shù)亩ㄆ陂g隔進(jìn)行備份。與儀器相關(guān)的軟件系統(tǒng)被連接到一個(gè)備份程序。此外，數(shù)據(jù)定期保存在一個(gè)外部硬盤中，并有適當(dāng)?shù)谋O(jiān)管。每年再進(jìn)行一次備份。

3

Concerning spreadsheets (e.g. Excel®), all cells including calculations  were locked so that formulas could not accidentally be overwritten. Free  access was only given to cells to be filled in with data. Calculation  algorithms were properly tested and confirmed. The validated Excel  spreadsheets were uploaded in the LIMS database system to provide protected  access by QA who also supervised and handled the obsolete versions. The used  spreadsheets were stored on the server in a specific folder. The sheets were  also printed out to be attached to the analytical documentation.

對(duì)于電子表格(如Excel®)，所有單元格包括計(jì)算都被鎖定，因此公式不會(huì)意外被覆蓋。只有要用數(shù)據(jù)填充的單元格才可以自由訪問(wèn)。對(duì)計(jì)算算法進(jìn)行了適當(dāng)?shù)臏y(cè)試和驗(yàn)證。經(jīng)過(guò)驗(yàn)證的Excel電子表格被上載到LIMS數(shù)據(jù)庫(kù)系統(tǒng)中，以提供QA的保護(hù)訪問(wèn)，QA還監(jiān)督和處理過(guò)時(shí)的版本。使用的電子表格存儲(chǔ)在服務(wù)器的特定文件夾中。這些表格也打印出來(lái)，附在原始記錄中。

4

Validation of computerized systems was initiated in accordance with an  SOP for Computerized Systems validation protocol. This SOP was mainly related  to the transfer of data from computer to the backup server for security of  storage of electronic data. The transfer of data from LIMS database to the  backup server was validated.

根據(jù)計(jì)算機(jī)化系統(tǒng)驗(yàn)證方案的SOP啟動(dòng)計(jì)算機(jī)化系統(tǒng)驗(yàn)證。該SOP主要涉及數(shù)據(jù)從計(jì)算機(jī)傳輸?shù)絺浞莘?wù)器，以保證電子數(shù)據(jù)存儲(chǔ)的安全性。驗(yàn)證了將數(shù)據(jù)從LIMS數(shù)據(jù)庫(kù)傳輸?shù)絺浞莘?wù)器。