CSV計(jì)算機(jī)系統(tǒng)驗(yàn)證

與GMP相關(guān)的計(jì)算機(jī)系統(tǒng)均為需要驗(yàn)證的計(jì)算機(jī)系統(tǒng)。 —般用于控制生產(chǎn)過(guò)程，或處理與產(chǎn)品制造、質(zhì)量控制、質(zhì)量保證等相關(guān)數(shù)據(jù)的計(jì)算機(jī)系統(tǒng)均應(yīng)驗(yàn)證。

With GMP relevant the computer system need to validation. Generally, all the systems should be verified , which is used to control the production process, or processing with product manufacturing, quality control, quality assurance and other relevant critical data computer system.

1.計(jì)算機(jī)系統(tǒng)驗(yàn)證計(jì)劃 主要闡述計(jì)劃的驗(yàn)證活動(dòng)、各部門(mén)職責(zé)以及批準(zhǔn)程序。

1. Computer system validation plan; state verification activities of plan, the responsibilities of each department and approval procedures.

2.計(jì)算機(jī)系統(tǒng)文件 這些文件至少應(yīng)有該系統(tǒng)性能描述、如何使用該系統(tǒng)及其相關(guān)的技術(shù)資料。

Computer system files: these files should have description of the system performance at least and how to use the system and its related technical information.

3.電子記錄和簽名 對(duì)于那些有電子簽名和電子記錄的系統(tǒng)，必須有相關(guān)文件及資料能證明這些電子的簽名或記錄是得到授權(quán)和可信賴的。

Electronic records and signatures; For those systems have electronic signatures and electronic records must have the relevant documents and information to prove that these electronic signature or record is authorized and reliable.

4.供應(yīng)商的評(píng)估報(bào)告 必須一份關(guān)于供應(yīng)商被如何評(píng)估(或?qū)徍?的報(bào)告，以便對(duì)驗(yàn)證活動(dòng)進(jìn)行正確評(píng)價(jià)。

Suppliers assessment report : You must have a report on how to assess(or audit) suppliers , so that correctly evaluate the validation activities.

5.測(cè)試報(bào)告文件應(yīng)能顯示計(jì)算機(jī)平臺(tái)、應(yīng)用軟件已正確安裝和測(cè)試，并且測(cè)試結(jié)果與預(yù)期—致，可以信賴并有重復(fù)性。

The test report files can indicate the computer system platform, application software are properly installed and tested ; the test results in line comply with intended expectation , for which is reliable and repeatable.

6.培訓(xùn): 包括操作和維護(hù)的軟件安裝，程序備份和恢復(fù)方法，災(zāi)難恢復(fù)，系統(tǒng)管理，基本的系統(tǒng)網(wǎng)絡(luò)故障診斷系統(tǒng);必須有相應(yīng)的培訓(xùn)文件和記錄

Training: Includes the installation of operation and maintenance software ,program backups , disaster recovery , system management , basic system network work ; There shall be associated training documents and records.

7.安全:需有相應(yīng)SOP或安全制度來(lái)控制進(jìn)入該系統(tǒng)。

Security: There must be the associated SOP or security measures to monitor the system access. corresponding SOP or security measures to control the operation of the system.

8.變更控制:必須有書(shū)面的文件

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