Signal simulators many be used in software validation 可以在軟件驗證中使用信號模擬器。
Electronic records are used but there was no software validation 使用電子記錄但軟件未經(jīng)驗證。
Although much of the software validation may be accomplished by outside firms , such as computer or software vendors , the ultimate responsibility for program suitability rests with the pharmaceutical manufacturer 雖然許多對軟件的驗證是由外部公司完成的,比如計算機(jī)或軟件供應(yīng)商,但最終負(fù)責(zé)程序適應(yīng)性的還是制藥公司。
Its a perfect combination of instrument technology and computer hardware and software technology the appearing of virtual instrument indicates that the computeration of instrument and the software validation of the measuring functions and the controls of instrument will be achieved , which will have significant influence on the development of instrument 虛擬儀器的出現(xiàn)標(biāo)志著儀器走向計算機(jī)化,儀器的測試功能和面板控件走向軟件化,這將對儀器的發(fā)展產(chǎn)生深遠(yuǎn)的影響。
Records of software validation should be maintained by the drug establishment , although when conducted by outside experts such records need not be voluminous but rather complete enough ( including protocols and general results ) to allow the drug manufacturer to assess the adequacy of the validation 雖然軟件驗證的記錄應(yīng)該由藥品公司保存,但當(dāng)外界專家管理這些記錄時可以不必有大量的記錄,但要有足夠完整的信息(包括方案和所有結(jié)論) ,以保證制藥商能對驗證的充分性進(jìn)行評估。