GOST R 54360-2011 Laboratory information management systems (LIMS) Standard quide for validation of LIMS《实验室信息管理的标准验证说明书 系统(LIMS)》.pdf

《GOST R 54360-2011 Laboratory information management systems (LIMS) Standard quide for validation of LIMS《实验室信息管理的标准验证说明书 系统(LIMS)》.pdf》由会员分享，可在线阅读，更多相关《GOST R 54360-2011 Laboratory information management systems (LIMS) Standard quide for validation of LIMS《实验室信息管理的标准验证说明书 系统(LIMS)》.pdf（44页珍藏版）》请在麦多课文档分享上搜索。

1、 543602011 -() ASTM E 2066:2007Standard Guide for Validation of Laboratory Information Management Systems(MOD) 27 2002 . 184- , 1.02004 . 1 - , , , 42 100 - 3 20 2011 . 190-4 - 2066:2007 - (ASTM E 2066:2007 Standard Guide for Validation of Laboratory InformationManagement Systems). :1) 1, 313 1-6 ,

2、/ ;2) 2 - . , , . , , - ;3) , - , . - ASTM 1.52004 ( 3.5).5 , - . - () . , , 2012 , - - II 5436020111 12 13 24 .45 46 .87 , 128 149 .1510 () .1811 2012 () (QAU).2413 .25 1 () .26 2 () .28 3 () 30 4 () 32 5 () 33 6 () , 34 () , .37 () 38 39III 543602011 - () Laboratory information management systems

3、(LIMS). Standard guide for validation of LIMS 201110011 1.1 - - ().1.2 , . -, . , , - , ( ). , -,.,- , ASTM (AmericanSociety for Testing and Materials), ISO (International Organization for Standardization) IEEE (Institute ofElectrical and Electronics Engineers) .1.3 , , , - , , , .2 2.1 : / 12207199

4、9 . (/ 12207:1995, IDT) / 147642002 . (/ 14764:1999, IDT) / 152712002 . / 12207 ( )(/ 15271:1998, IDT) 90002008 . ( 9000:2005, IDT) 90012008 . ( 9001:2008, IDT) 90042001 . - ( 90042000, IDT)1 543602011 100052007 . ( 10005:2005, IDT) 100062005 . ( 10006:2003, IDT) 100072007 . - ( 10007:2003, IDT) 190

5、112003 / ( 19011:2002, IDT) 537982010 - () ( 1578:2006) - - - , 1 , , . (), - () . , , - , , .3 3.1 , . , 2, , - .3.1.1 (acceptance criteria): , , , , .3.1.2 (change control): , , , , , - , . - (Quality Assurance, QA) (Standard Operation Procedure, SOP).3.1.3 (configuration management): , , , , .3.1

6、.4 (customization): , , - . , , - . , - .3.1.5 (delivered system): , - - . , , . , , , , 7.3.1.6 (dynamic testing): .2 5436020113.1.7 (Installation Qualification, IQ): () , - , , .3.1.8 (Laboratory Information Management System, LIMS): - , , , , , , , .3.1.9 () LIMS data loading (configuration): - ,

7、 , . , , - , , , , . . - , . .3.1.10 (LIMS tailoring): . ().3.1.11 (Operational Qualification, OQ): , , - .3.1.12 (Quality Assurance Unit, QAU): (), , - , ( ).3.1.13 (source code): , - ( ), ( ) , .3.1.14 (static testing): .3.1.15 , - (stress testing): , , .3.1.16 (test plan): . .3.1.17 (test protocol): , , -, , - , .3.1.18 (validation): , , - , , -, ( , , . .).3.1.19 (validation plan): , -, , , , .3.1.20 (validation team): , -.