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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

21 Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 18

22 1. 2. (1) (2) (3) (4) (5) (6) (1) (2) (3) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 19

23 (1) (2) (1) (2) (3) (4) 5. Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 20

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