1、 318872012 , (C)INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC) (GLP) GLP 318872012II, - 1.092 . - 1.22009 . -, . , , , 1 : - , , ( ); 339 , ; 339 , 2 3 , (- 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYKZKGMDRUTJ -4 OECD series on Principles of Good Laboratory Practice a
2、nd Compliance Monitoring No 10 GLP consensus document The application of the principles of GLP to computerized systems: 1995 ( GLP. :1995, 10 - () GLP ). , . GLP. (en). , , . (IDT). : . - .5 27 2012 . 2153- 318872012 - 1 2013 . 318872012 III , 2013 -, 6 - , - . () . - , 318872012IV1 . . . . . . . .
3、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 GLP . . . . . . . . . . . . . . . . . . . . . . . .
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5、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 318872012 V - () (GLP), 58 1992 . (Interlaken), , GLP . (Dr. Theo Helder), GLP , , - - (Mr. Bryan Doherty, Chairman of the Computing Committee of the British Association for Research Quality Assurance). - GLP, , , , , , , ,
6、, , , -. , GLP, , , . . GLP 1993 . - , 1416 1994 . - (Dr. Helder), (Mr. Doherty) , - , , , , , , , . , , -, - . , , . .1 201301011 1.1 -, , (GLP). - , . - , , , . 1.2 , , - , , , , () GLP 1. , - . , / - , , . - - - (). GLP .2 :2.1 (acceptance criteria): , . 2.2 (acceptance testing): - - , .2.3 (back
7、-up): , , - .2.4 (change control): - . 318872012 (GLP) GLP Principles of Good Laboratory Practice (GLP).Applikation of GLP Principles to computerised systems 31887201222.5 (computerised system): , .2.6 (electronic signature): - () , -, - .2.7 (hardware): -, , .2.8 (peripheral components): - , , , .
8、.2.9 (recognised technical standards): , - ISO, International organization for standartization ( , ); IEEE, Institute of Electrical and Electronics Engineers ( ); ANSI, American National Standards Institute ( ) . .2.10 (security): , , , -. , , .2.11 (software application): , - , - , , / .2.12 (software operating system): - , () , - . , , , / .2.13 (source code): , - ( ), - , .2.14 (validation of a computerised system): - , .3 GLP 3.1 , , , , . , - GLP, , . , , . - . .3.2 GLP GLP 3.2.13.2.9.3.2.1 ) - GLP, - 318872012 3 ,
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