コンピュータバリデーション

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1 HP

2 ?????????

3 HP Report

4 21 CFR Part 11, : FDA Observations and warning letters Choose View, Header and Footer to enter text here sa

warning letters http://www.fda.gov/cder/esig/index.

5 FDA 21 CFR Part 11: validation record

6 21 CFR 11 GMP

7 21 CFR Part 11 voltage page x of y area slice chromatographic line zero line time ( )

8 =? FDA ==>??

10 , sa Choose View, Header and Footer to enter text here

11 ? HP Agilent/YAN

13 Design Qualification Installation Qualification Operation Qualification Performance Qualification

14 (DQ) (DQ) (IQ) (IQ) (OQ) (OQ) (PQ) (PQ)

15 Q Q DQ IQ OQ PQ

16 Q DQ IQ OQ PQ

17 (DQ) (DQ) (IQ) (IQ) (OQ) (OQ) (PQ) (PQ)

18 DQ IQ IQ OQ PQ

19 2

20 Responsibilities of Vendors/Users "It is the responsibility of the user to ensure that the software program has been validated" "It is acceptable for formal validation of software to be carried out by the supplier on behalf of the user, provided that the user undertakes a formal acceptance test" OECD OECD GLP Principles, Monograph 49 The responsibility for demonstrating that systems have been validated lies with the user" "Without prior written assurance from the vendor, the laboratory should not automatically assume that the vendor supplied software has been properly validated" FDA Tetzlaff, FDA Inspector, Pharm.Technol., May 1992, 71/82 sa OECD=Organization of Economic Cooperation and Development FDA = Food and Drug Administration Choose View, Header and Footer to enter text here

validated lies with the user" "Without prior written assurance from the vendor, the laboratory should not automatically assume that the vendor supplied software has been properly validated" FDA

21 Let s Start! DQ IQ IQ OQ PQ

22 HP

23 ? SOP

24 OS PC

25 ( ) Windows NT Windows 95 Unix Agilent

26 / / Certified by ISO 9001 and ITQS/ TickIT / 7673 HEWL PACKA ETT RD A START FAULT RUN AUTOMATI SAMPLE READY STOP RC /

27 OS Agilent Windows NT Windows 95 Unix

28 PC

29 vs OS PC

30 DQ DQ IQ IQ OQ PQ

31 (DQ) (DQ) (IQ) (IQ) (OQ) (OQ) (PQ) (PQ)

32 DQ HP

33 HP

34 Permission Denied!! OS Windows NT

35 40 40

37 min ( V min) mv

38 DQ

39 DQ sa Choose View, Header and Footer to enter text here min ( V min) mv

40 DQ-3 Windows NT

41 DQ-3 OS:Windows NT CPU:>Pentium 250MHz HD >2G RAM:>48MB CD-ROM drive:yes Display:Super VGA, >17inch Printer:>Laser Pinter HP

42 DQ-4 ISO 9001 TickIT ITQS(ISO ), IQ/OQ : GLP/GMP

43 Q DQ IQ OQ PQ

44 DQ IQ IQ OQ PQ

45 (DQ) (DQ) (IQ) (IQ) (OQ) (OQ) (PQ) (PQ)

46 IQ Agilent

47 (RAM) ( ) CD ROM

48 ???

49 PC 523 ChemStation 06.01

50 IQ

51 OQ DQ IQ IQ OQ PQ

52 (DQ) (DQ) (IQ) (IQ) (OQ) (OQ) (PQ) (PQ)

53 OQ DQ Agilent

54 ( ) Agilent /

55 GLP/GMP FDA 21CFR Part 11 Implentation on Agilent ChemStation Plus (21CFR Part 11)

56 OQ : OQ? :.

57 Agilent

58 OQ

59 OQ -

60 OQ y=ax+b a,b 1 2 min ( V min) mv

61 1 2 3

63 OQ

64 OQ HP

67 X Y Z Y

68 OQ NT

69 PQ DQ IQ IQ OQ PQ

70 (DQ) (DQ) (IQ) (IQ) (OQ) (OQ) (PQ) (PQ)

71 PQ

72 DQ IQ IQ OQ PQ

73 YAN/Agilent 1 2 Agilent 1100 OQ/PV

74 HP A.06.XX HP HP Rev HP A.06.XX HP HP HP1100 HPLC HP HP Rev Rev

75 Agilent IQ

76 IQ 1 instrmnt.ini repstyle library.mac 1 verify default.val integ.reg helpenu hpsc6a00.hlp Initialization Macro Register Help core 800 eevempt.ini core 800 eevtool.ini editor.hlp apg_top.exeapgdde.dll sa Initialization Initialization HELP DataComm HP APG Choose View, Header and Footer to enter text here

77 Agilent 1100 OQ/PV OQ/PV Supporting documents HP sa Choose View, Header and Footer to enter text here

78 IQ IQ Agilent 1100 IQ IQ OQ/PV f o r Agilent 1100 OQ/PV f o r f o r EN GUIDE 25 f o riso

79 Agilent/YAN DQ IQ Agilent1100 IQ IQ OQ Agilent1100 OQ/PV OQ/PV PQ SST EMF CD-ROM

80 Agilent 1100 Agilent 1100 HPLC Agilent 1100 IQ IQ OQ/PV Agilent 1100 Ehanced OQ/PV Agilent 1100 OQ/PO IQ Agilent 1100 Enhanced OQ/PV

81 OK, Agilent/YAN is the only one vender who has a perfect solution for Computer System Validation

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