制藥生產(chǎn)全過程信息化監(jiān)控軟件基本要求

1、備案號(hào)：xxxxx2012DB31上海市地方標(biāo)準(zhǔn)DBDBxxxxxxxxxxxx—20122012藥品生產(chǎn)質(zhì)量管理系統(tǒng)信息化技術(shù)規(guī)范TheITStardofpharmaceuticalproductionqualitymanagementsystem2012xxxx2012xxxx發(fā)布發(fā)布2012xxxx2012xxxx實(shí)施實(shí)施發(fā)布DBxxxxxxDBxxxxxx—20122012I目次前言.......................

2、........................................................................................................................................II1范圍范圍.............................................................................

3、...............................................................................12規(guī)范性引用文件規(guī)范性引用文件.............................................................................................................................

4、............13術(shù)語和定義術(shù)語和定義.................................................................................................................................................14總則總則.............................................

5、...............................................................................................................85基礎(chǔ)信息管理基礎(chǔ)信息管理...............................................................................................

6、..............................................86機(jī)構(gòu)與人員管理機(jī)構(gòu)與人員管理.........................................................................................................................................97庫存管理庫存管理...........

7、........................................................................................................................................108采購(gòu)管理采購(gòu)管理.........................................................................

8、..........................................................................119工藝及配方配套工藝及配方配套.................................................................................................................................

9、......121010生產(chǎn)管理生產(chǎn)管理...................................................................................................................................................131111質(zhì)量管理、控制與保證質(zhì)量管理、控制與保證...........................

10、.................................................................................................141212設(shè)備管理設(shè)備管理.............................................................................................................

11、......................................151313文件管理文件管理...................................................................................................................................................161414銷售、發(fā)運(yùn)與召回銷售、發(fā)運(yùn)與召

12、回....................................................................................................................................161515國(guó)家藥品電子監(jiān)管碼管理國(guó)家藥品電子監(jiān)管碼管理...........................................................

13、.............................................................171616信息系統(tǒng)環(huán)境與用戶界面信息系統(tǒng)環(huán)境與用戶界面........................................................................................................................181717信息系統(tǒng)整

14、合信息系統(tǒng)整合...........................................................................................................................................191818信息系統(tǒng)質(zhì)量保證信息系統(tǒng)質(zhì)量保證....................................................

15、................................................................................20附錄附錄A.....................................................................................................................................