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1 /05/ /07/ /03/28 Copyright(C) 2006 ecompliance Ltd. All Rights Reserved.
2 ER/ES ER/ES ER/ES ER/ES Copyright(C) 2006 ecompliance Ltd. All Rights Reserved.
3 ER/ES ER/ES ER/ES ID ER/ES Copyright(C) 2006 ecompliance Ltd. All Rights Reserved.
4 ER/ES ) 2) 3) 1) 2) 4) Contract Research Organization: CRO CRO 2.2 1) ER/ES ER/ES Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 1
5 ) 2) 3) ) 2) 3) 1) 2) 4) 1) 2) USB Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 2
6 ER/ES ) 2) 4. 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 3
7 5. ER/ES 1) 2) 3) 4) 5) 6) 6. ER/ES 6.1 ER/ES ER/ES 6.2 ER/ES 1) 2) 3) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 4
8 Computerized System Validation CSV CSV 1) CSV CSV CSV 2) 3) 4) CSV ER/ES 1) 2) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 5
9 3) 4) (1) 1) 2) 3) 4) 5) 6) 7) ID administrator root supervisor system manager ID ID ID 8) 9) (1) (2) (3) 1) 15 2) (2) 1) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 6
10 2) 3) 4) 5) 1) 2) (1) (2) (3) EDC 3) (1) (2) (3) (4) 4) PDF XML 5) (3) 1) 2) 3) 1 1 4) 5) 6) 7) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 7
11 1 2 (1, 2) 1) 2) CD-R 3) ) 2) 3) 1) (1) 1) 2) 3) (1) (2) (3) (4) (5) (6) (7) (2) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 8
12 1) 2) 3) PDF XML SGML 4) 1) 2) 3) 4) ) 2) GxP Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 9
13 ) 2) ID (1) ) 2) (1) ID (2) 3) 4) 1) (2) 1) 2) 3) 4) (1) ID Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 10
14 (2) (3) 1) (4) 1) 2) 3) 4) 9. ER/ES ER/ES OJT 1) 2) 3) 9.1 ER/ES ER/ES 1) ER/ES ER/ES ER/ES 2) ER/ES ER/ES 3) ER/ES ER/ES ER/ES ER/ES 9.2 ER/ES 1) 2) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 11
15 3) ER/ES 4) ER/ES Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 12
16 9.3 ER/ES 1) (1) ER/ES (2) (3) OJT 2) (1) (2) (3) OJT 3) (1) ER/ES a) b) c) d) e) 4) (1) 1/3 ER/ES a) b) c) d) 9.4 1) OJT ER/ES 2) 3) ER/ES GxP Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 13
17 ) 2) 3) 4) 5) 6) 7) * 8) (1) (2) 9) 10.2 ID ID 1) 2) ID 3) 4) ID 5) ID 6) ID 7) (1) 90 (2) 6 (3) (4) (5) 8) 9) 10) 11) 12) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 14
18 10.3 1) 3 ID (1) (2) 2) 3) etoken SecureID 4) ) (1) (2) (3) 2) (1) (2) ) ) JST 12:34:56(GMT) 2) 24 3) 02March ) UPS 2) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 15
19 11. ER/ES ER/ES ER/ES 1) 2) 3) 4) 5) 6) ) ER/ES 2) ER/ES GxP Title 21 of the Code of Federal Registers Part 11, Electronic Records; Electronic Signatures FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application FDA CSV 200X X X CSV 200X X X 200X X X 200X X X 15. Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 16
20 e (1) (2) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 17
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