大阪府における「コンピュータ化システム適正管理ガイドライン』に係る
Contents
1. 5 32. 6 6 1
3. CSV 1 4 GIMP GQP 1 GM
4. CSV
5. 23 32 6 2
6. 4 22 32 4 No 4
7. 6 3
8. 2 13 32 PLC
9. PLC 2 1 O x 3 7 7 PLC PLC 72001 7 7 7 7 12010 7 7 7 10O41 7 2 H30011 0 7
10. 8 32 GMP GQP GMP
11. 4 5 22 10 21 1021 11 GQP GMP
12. OQ OQ PQ 5 7 10 DQ 5 7 11 IQ
13. 06 6941 0351 4554 FAX 06 6944 6701 CSV 1 CSV 1 1 2 4 2 5 2 2 4 4 2 2 4 2 5 GMP 2 CSV
14. 21 32 5 7 8 FAT SAT 5 7 9
15. 5 5 GQP GMP 8 8 1
16. CS V P LC GMP P LC 1 C SV PLC CPU ON OFF
17. 2 5 7 15 5 8 5 9
18. GMP 1 2 3 4 5 7
19. 5 1 5 2 5 4
20. 27 32 3 2 2 3
21. 1 2 4 4 1 2 4 4 1 1 major 2 2 minor
22. 3 4 3 5 28 32
23. PLC PLC 2 IT TIT
24. 6 4 7 5
25. 5 7 5 5 DQ 5 7 6 1 5 1 2 5 2 3 5 3 5 7 7
26. 3 2 1 3 3 3 Service Level Agreement SLA
27. GMP GQP GMP GQP 2 1 1 1 7 2 6 2 http www fpmgi grjp documentssysutem666 pdf HP 2 7 2 9 32 2 1 2 3 GMP GQP 4
28. 5 7 12 OQ 5 7 13 PQ 5 7 14
29. 2 CS V GQP GMP 2 4 4 1
30. CSV IT TT 3 1 2 4 3 3 1
31. 6 CSV 2 4 3 3 1 Q amp A 2 1 1 CSV PLC 1
32. 15 32 16 32 O OO 001 01 201X 00 00 GMP GQP OO 9 1 GQP GMP 2 22 10 21 1021 11 3 GQP GMP
33. 1 3 IT 60001 ET T 1 IT CSV IT GMP GQP Q amp A 3 32 1 x IT
34. GMP QP 3 1 3 3 2 3 2 1 4 1 2
35. 24 32 8 2 5 LL hae e WwW
36. 5 2 6 2 1 1 6 32 2 2 CSV 1 2 2
37. GQP GMP 1 17 32 eA TD 1 5 1 1 1 RE OS 2
38. 3 7 3 GQP GMP
39. 2 1 2 3 4 5 6 8 9 3 3 1 3 1 1 3 1 2
40. VPLO LIMS SCADA lt ERP MRPII DCS EDMS IT ei ed 3 4 PLC 18 32 5 2
41. PLC IT GIMPGQP GIMPGGQP IT IT GMP GQP 1 CSV
42. GMP 1 2 3 19 32 DQ IQ OQ PQ 5 6
43. 3 5 7 1 5 7 2 5 7 3 5 7 4 20 32 3 3 4 as ee ee
44. 3 GIMPYGQP GMPGQP GMP GQP 10 32 4 4 1 1 4 2 http www fpmgi grjp documents sysutem666 pdf H P 2 8 3 2 1
45. PLC Programmable logic controller CS V CS V CSV 1 CSV
46. 22 10 2 1 1021 1 1 Q amp A Q amp A 22 10 21 2 TT 3 DO 2 CSV 4 2
47. CSV GMP GQP GMP GQP GMPGQP 1 1 1 GMP GQP
48. 3 6 3 6 GQP GMP GMP
49. 1 GMPGGQP GMP GQP PLC 2 1 2 1 2 32 1
50. GMPGQP GMP GQP PLC CSV GMP GQP
51. CSV CSV CSV 5 32 2 CSV 2 2 1 2 4 4 1 1 GIMP GQP CSV CSV
52. 1 8 2 3 2 5 5 1 12 29 1 2 4O 1 3O 3 1 5 51 2 5 8 3 2 2 32 32 540 8570 2 1 22 TEL O6 6942 035 1 4554 O6 6941 8079 FAX O6 6844 670 1
53. GAMP 2 2 5 5
54. 29 32 6 QP GMP 1 201X 00 00 Ver 1 0 30 32 1 GQP GVP GMP QMS 2 1 GQP GMP QMS 2 3 4 5 GVP 6 3
55. DQ IQ OQ PQ O CS OO OO GQP GMP OQ AN Oo Fo wm D
56. GMP 4 8 GQP GMP 4 9 GQP GMP 1 1 4 10 1 1 5 GQP GMP
57. 3 1 CSV GMP GQP GMP GQP GMP GQP 2 1 D 2 7 3 0 2 3 0 0 3 1 2
58. CSV GMP GQP CSV CSV 3 CSV 4 2 CSV 2 4 3 3 1 7 32 2 1
59. CSV TT 3 GMPGGQP GIMPGGQP 14 32 4 Y12001 Y12010 Y21001 Y21041 Y40002 10110 10112 Y51005 HPLC 2012 01 06 2012 01 06 2012 01 10 2012 01 10 2012 02 0
60. 25 32 9 OOO Cxxx 01 GQP GMP 1 0 OOO Cxxx 01 GQP GMP 1 201X 00 00 Ver 1 0 _ 26 32 O OO 001 01 201X 00 00 4 1 22 10 21 1021 11 GXX 001 01
61. Excel 1 GMP GQP C SV A 0025 01 Am Wm mg WgyWrxPxAr Asxa bxk 1 CSV 1 IT OWN 2 2 1 2 2 2 DR DS 1 2
62. 8 1 2 2 4 5 3 6 2 2 7 6 1 1 4 17 5 3 0 2 1 4 1 31 32 2 4 2
63. 1 2 recommend 3 CSV CSV GQP GMP GQP GM P 16 136 2 16 179 24 2 22 10 2 1 102 1 1 1
64. 6 O Oo O 6 Oo A O A O EE EE EE EE DQ laA lo QI O O O OOO A O PQ O ol ol kz amp l elio il OQ PQ
65. 2 4 4 1 2 2 4 4 1 11 32 gE 4 1 IEEE om on on FT Y21041 1 2000706706 2012701 10 FT Y12001 1 2001 01 26 2012 01 06 11003 2 1 ll 2 IT Ca Wa me lt m eaes gear lmes Taam LIMS 3 2 20080411 2008 04 20 13021 5 gt 1 3 1 EE 9 O RE 2 Epon oo CO 4 IT 5
66. 1 1 32 1 CSV T T OO OO CSV CSV GMP7GQP CSV 1 GIMPGQP CSV GMP GQP CSV CSV 1 1 3 CSV
67. CSV Q amp A 22 10 2 1 Q amp A 2 4 4 1 GMP CSV CSV 4 2 2 1 1 1
68. 4085 24 2 29 22 10 21 1021 11 T CSV 24 4 1 CS V C SV 24 4
69. 2 3 3 2 4 3 1 2 3 3 3 3 1 3 2 1 3 3 2
70. 1 2012 01 11 2012 01 11 2012 01 11 PIP HPLC
71. PGQP 1 2 1 3 GIMPGQP 4 32 2 1 Excel GMP GQP GMP GQP 1 RTT 2 2 Leeewm zw ol 5 1 2 1 4 CSV 2 1
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