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GHS 開発ガイドライン 適合宣言 実施ガイド
Contents
1.
2. GHS 1 8 GHS GHS GHS GHS HS http good hs jp
3. a http 7 www meti go p committee kenkyukarshoujo iryou software report 002 html b 2014 http www meti go p polcy mono info service service iryou fukushdownloadfiles 201407 1 pdf 2 2
4. GHS GHS Level 1 83 3
5. MMP O 5
6. GHS 1 2 3 4 GHS GHS http good hs jp GHS Ver 1 00 13 20 3 5 8 5 1 1
7. 6 Web URL Web GHS Web 8 5 2 GHS
8. 3 GHS GHS 4 GHS GHS Good Health Software http good hs jp GHS Ver 1 00 19 20 GHS
9. GHS PDTF GHS Web A4 1
10. GHSS http good hs jp GHS Ver 1 00 11 20 3 8 1 a GHS GHS GHS Level
11. 1 1 2 GHS H H GHS
12. Ver 1 00 18 20 GHS 5 6 GHS 5 1 8 GHS 5 2 1 GHS GHS 2
13. 2018 11 27 FE Ne 1H Ver 1 00 os HH
14. GHS GHS A 1 3 2 1 1
15. 8 2 2 3 2 3 http qood hs jp GHS
16. GHS http good hs jp GHS Ver 1 00 2014 11 GHS Ver 1 00 100 0004 1 1 3 03 3217 2555 Good Health Software Promotion Council 2014 GHSS http good hs jp 20720
17. 5 II Guideline Version Ver 1 00 iClause 13 2 Compliance Conformity result Remark IN A Test date 2014 12 01 2014 12 12 Guideline Approved date 2014 12 15 Approved by Signature This report shall not be reproduced except in full without the written approval of Good Health Software Promotion Council Copyright 2014 All rights reserved 5 GHS
18. HS Good Health Software http good hs jp 5 5 1 5 1 1 GHS GHS 1 3 2 4 5 2 5 1 2 GHS 1 2 3 4
19. GHS GHS GHS GHS Web 2 16 20 b 5 k GHS GHS GHS lt
20. Pass Fail N A Not Applicable SE a FE TT 4 GHS http good hs jp GHS Ver 1 00 10 20 T
21. 5 20 Ve GHS 4 1 2
22. 3 5 8 8 6
23. ee GHS 6 a GHS iii GHS 5
24. 7 GHS 4 1 GHS GHS GHS GHS GHS GHS GHS 4 2 GHS GHS GHS GHS
25. GHS GeHs GHS GHS 1 GHS GHS GHS GHS Web 1 Good Health Software http good hs jp GHS Ver 1 00 7 20 2 2 1 2014
26. il GHS 8 0 Cc 5 GHS Level 2 SO9001 support ooxx com TEL 03 0000 0000 FAX 03 0000 0001 100 0000 OO OO0 0 0 Web http www ooxx com products HealthSoftware GHS GHS GHS GHS
27. 4 a b GHSS http good hs jp GHS Ver 1 00 14720
28. GHS a a
29. 4 3 2 GHS GHS GHS 2014 12 2015 12 GHS HH 1 GHS 2 1 2 2 Level 1 Level 2 Leve 3 20 000 20 000 30 000 20 000 20 000 30 000 4 8 8
30. 2 GHSS http good hs jp GHS Ver 1 00 15 20 4 GHS GHS GHS 7 GHS _ GHS Web _ GHS
31. GHS GHS HS Good Health Software http good hs jp GHS Ver 1 00 17 20 GHS Level 1 2 Level 3 4 8 4 GHS GHS GHS Web
32. Ver 1 00 12 20 3 2 4 MO 2
33. GHS GHS E GHS GHS GHS GHS H Dy i GHS GHS GHS
34. kk 8 5 8 ki 3 6 kk AGHS 4 1 GH8S 4 2 GHS 4 8 ki 4 8 1 kk 4 3 2 GHS kk 4 8 3 kk 4 3 4 GHS i 4 4 GHS 5 1 kk 5 1 1 5 1 2 GHS http qood hs jp 3720 0332458888 2 6 SN 7 GHS Ver 1 00 4720 5 1 8 GHS kk 18 5 2 i 18 ki 19 http qood hs jp GHS 1 1
35. 3 GHS 5 GHS GHS GHS GHS GHS 6 GHS GHS 7 GHS GHS GHS
36. GHS GHS Dl 1 2 3 4 5 6 Web 7 8 GHS GHS GHS GHS GHS GHSS http good hs jp GHS Ver 1 00
37. A B C D ISO 14971 2007 ISO 9001 2008 IEC 82304 1 CD IEC 62304 2006 3 2 3 1 4 2 4 6 2 5 6 4 NG Level 1 Level 2 1 2 Level3 1 Leve 3 A D ALL 2 2 IEC 82304 1 2 5 4
38. 5 2 8 4 Level 1 8 Level 2 1 2 Level 3 4 2 GHSS http g
39. 3 IE 2 Er EE 9 2 te ETIDET 3 RE gg 9 Ra cp SPe Ora ame ys PF i co GHS et Ie Pt oor Good Health Hs 3 http qood hs jp GHS Ver 1 00 9720 5 A D ALL 1 1
40. GHS GHS 4 4 GHS GHS GHS GHS GHS GHS GHS 1
41. Good Health Software GHS Ver 1 00 6 20 GHS GHS GHS GHS GHS GHS 1 4 1 2 GHS
42. GHS Good Health Software GHS Ver 1 00 2014 11 19 http qood hs jp GHS Ver 1 00 2720 Ver 2014 11 19 1 00 GHS http dood hs jp GHS Ver 1 00 11 N14 1 2 kk 1 8 GH8 kk 1 4 kk 2 i 2 1 Lk 2 2 kk 2 8 i 2 4 kk 2 5 i 3 kkk 2 8 2 kk 8 2 1 3 2 2 Dy 8 2 8 8 2 4 kk 8 8 kik 34 NSR El 8 5
43. GHS GHS GHS GHS GHS H GHS GHS
44. ood hs jp Q ej N J a MM Ver 1 00 8720 SO 13485 NH GHS 2 GHS 2 4 1 3 Good Health Software A ER Tri Tue rmpod tomit a de zseptin A watnout the wrtan approrai of G00 ham et occ HS ee LE GHS 2
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