新版GMP對自動化設備、計算機系統軟件的驗證要求

　　CSV計算機系統驗證

　　與GMP相關的計算機系統均為需要驗證的計算機系統。 —般用于控制生產過程，或處理與產品制造、質量控制、質量保證等相關數據的計算機系統均應驗證。

　　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.計算機系統驗證計劃 主要闡述計劃的驗證活動、各部門職責以及批準程序。

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

　　2.計算機系統文件 這些文件至少應有該系統性能描述、如何使用該系統及其相關的技術資料。

　　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 對于那些有電子簽名和電子記錄的系統，必須有相關文件及資料能證明這些電子的簽名或記錄是得到授權和可信賴的。

　　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.供應商的評估報告 必須一份關于供應商被如何評估(或審核)的報告，以便對驗證活動進行正確評價。

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

　　5.測試報告文件應能顯示計算機平臺、應用軟件已正確安裝和測試，并且測試結果與預期—致，可以信賴并有重復性。

　　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: 包括操作和維護的軟件安裝，程序備份和恢復方法，災難恢復，系統管理，基本的系統網絡故障診斷系統;必須有相應的培訓文件和記錄

　　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SOP或安全制度來控制進入該系統。

　　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:必須有書面的文件