untitled

http://www.ecompliance.co.jp 1.0 2006/05/26 1.1 2006/07/24 1.2 2007/03/28 Copyright(C) 2006 ecompliance Ltd. All Rights Reserved.

1....1 2....1 2.1...1 2.2...1 3....1 3.1...1 3.2...1 3.3...1 3.4...1 3.5...1 3.6...2 3.7...2 3.8...2 3.9...2 3.10...2 3.11...2 3.12...2 3.13...2 3.14...2 3.15...3 3.16 ER/ES...3 3.17...3 3.18...3 4....3 5....4 6. ER/ES...4 6.1 ER/ES...4 6.2 ER/ES...4 7....5 7.1...5 7.2...5 7.2.1...5 7.2.2...5 7.2.3...5 7.2.4...5 7.2.5...6 Copyright(C) 2006 ecompliance Ltd. All Rights Reserved.

7.2.6...6 7.2.7...7 7.3...7 7.4...8 7.4.1...8 7.4.2...8 7.5...9 7.6...9 8....10 8.1...10 8.2...10 8.3...10 8.4...11 8.5...11 9....11 9.1 ER/ES...11 9.2 ER/ES...11 9.3 ER/ES...13 9.4...13 10....14 10.1...14 10.2 ID...14 10.3...15 10.4...15 10.5...15 10.6...15 10.7...15 11....16 12....16 12.1 ER/ES...16 12.2...16 13....16 14....16 15....16 Copyright(C) 2006 ecompliance Ltd. All Rights Reserved.

1. 0401022 17 4 1 ER/ES 2. 2.1 1) 2) 3) 1) 2) 4) Contract Research Organization: CRO CRO 2.2 1) ER/ES ER/ES 3. 3.1 3.2 3.3 3.4 3.5 Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 1

3.6 3.7 3.8 3.9 3.10 1) 2) 3) 3.11 1) 2) 3) 1) 2) 4) 1) 2) 3 3.12 USB 3.13 3.14 3.15 3.16 1 Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 2

3.17 3.18 ER/ES 3.19 3.20 1) 2) 4. 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 3

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

7. 7.1 3. 3.1. Computerized System Validation CSV CSV 1) CSV CSV CSV 2) 3) 4) CSV 7.2 3.1.1. 7.2.1 7.2.2 7.2.3 7.2.4 ER/ES 1) 2) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 5

3) 4) 7.2.5 3.1.1. (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) 7.2.6 3.1.1. (2) 1) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 6

2) 3) 4) 5) 1) 2) (1) (2) (3) EDC 3) (1) (2) (3) (4) 4) PDF XML 5) 7.2.7 3.1.1. (3) 1) 2) 3) 1 1 4) 5) 6) 7) 7.3 3.1.2. Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 7

1 2 (1, 2) 1) 2) CD-R 3) 7.4 3.1.3. 1) 2) 3) 1) 7.4.1 3.1.3. (1) 1) 2) 3) (1) (2) (3) (4) (5) (6) (7) 7.4.2 3.1.3. (2) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 8

1) 2) 3) PDF XML SGML 4) 1) 2) 3) 4) 7.5 3.2. 3.1 4. 7.1 7.4 8. 7.6 3.3. 3.1 4. 7.1 7.4 8. 1) 2) GxP Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 9

8. 4. 1) 2) ID 8.1 8.2 4. (1) 12 5 31 102 12 5 31 102 1) 2) (1) ID (2) 3) 4) 1) 8.3 4. (2) 1) 2) 3) 4) (1) ID Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 10

(2) 8.4 4. (3) 1) 8.5 4. (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

3) ER/ES 4) ER/ES Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 12

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

10. 10.1 1) 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

10.3 1) 3 ID (1) (2) 2) 3) etoken SecureID 4) 10.4 1) (1) (2) (3) 2) (1) (2) 10.5 1) 10.6 1) JST 12:34:56(GMT) 2) 24 3) 02March2006 2006 3 2 10.7 1) UPS 2) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 15

11. ER/ES 12. 12.1 ER/ES ER/ES 1) 2) 3) 4) 5) 6) 12.2 1) ER/ES 2) ER/ES GxP 13. 14. 0401022 17 4 1 12 5 31 102 16 149 44 17 3 25 Title 21 of the Code of Federal Registers Part 11, Electronic Records; Electronic Signatures FDA 1997 8 20 Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application FDA 2003 9 5 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

0401022 17 4 1 1. 14 151 16 149 e- 13 3 30 39 334 16 5 27 0527001 2. 3. (1) (2) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 17

4. 17 4 1 5. Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 18

1. 2. (1) (2) (3) (4) (5) (6) 3 3.1. 3.1.1. (1) (2) (3) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 19

3.1.2. 3.1.3. (1) (2) 3.2. 3.1 4. 3.3. 3.1 4. 4. (1) 12 5 31 102 (2) (3) (4) 5. Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 20