4 0 8 5

24 2 29

22 10 21 1021 11

24 4 1

24 4

06-6941-0351 4554

FAX 06-6944-6701

1

major

2

minor

recommend

*1 16 136

*2 16 179

Programmable logic controller

-0025-01

ATn) (WTn) (mg) ( )1 #DIV/0!2 #DIV/0!3 #DIV/0!

AVE #DIV/0!SD #DIV/0!

RSD #DIV/0!

(%) WS/WTn×P×ATn/AS×a/b×k

/

1 / 32

CSV

IT

2 / 32

1 CSV

CSV CSV

GMP/GQP

CSV

GMP/GQP CSV

GMP GQP CSV

CSV

CSV

PLC

GMP/GQP

IT

GMP/GQP

IT

3 / 32

PLC

PLC

PLC

IT

IT IT

CSV IT GMP/GQP

Q&A

4 / 32

CSV

GMP/GQP

GMP/GQP

GMP/GQP

IT

5 / 32

Excel GMP/GQP

GMP/GQP

GMP/GQP

CSV

CSV

CSV

CSV

6 / 32

CSV

GMP/GQP CSV

CSV

Q&A

Q&A

IT

CSV

1

7 / 32

CSV

CSV

GMP/GQP CSV

CSV

CSV

CSV

8 / 32

CSV

GMP/GQP

GMP/GQP GMP/GQP

CSV

GMP/GQP

PLC

IT GMP/GQP

GMP/GQP IT

IT

GMP/GQP

9 / 32

CSV

GMP/GQP

GMP/GQP

GMP/GQP

http://www.fpmaj.gr.jp/documents/sysutem666.pdf

GMP/GQP

GMP

GMP/GQP

GMP/GQP

PLC

10 / 32

GMP/GQP

CSV GMP/GQP

GMP/GQP

GMP/GQP

GMP/GQP

GMP/GQP

GMP/GQP

11 / 32

http://www.fpmaj.gr.jp/documents/sysutem666.pdf

CSV

IT IT IT

Y21041 1 PLC 3 2000/06/06 2012/01/10

Y12001 1 PLC 3 2001/01/26 2012/01/06 11003

2.1

IT

LIMS 3.2

4 2008/04/11 2008/04/20 MM 13021 13022 1

13023 2

13024

13025 HPLC

20188 QC 1.2 4 Excel2001 2004/06/12

22530 1 A 2.1 4 Excel2007 2008/06/15 CD

22531 1.3 4 Excel2007 2008/08/01

IT

20227 QA SAP 2.1 4 2003/06/27

13 / 32

IT CSV

CSV

Q&A

CSV PLC

14 / 32

PLC

PLC

PLC

IT

IT

CSV IT

GMP/GQP

GMP/GQP

15 / 32

Y12001 1

2012/01/06

Y12010

1

2012/01/06

Y21001 PTP

1 2012/01/10 PTP

Y21041

1 2012/01/10

Y40002

2012/02/01

10110

GMP

2012/01/11

10112

GQP

2012/01/11

Y51005 HPLC 2012/01/11

HPLC

16 / 32

17 / 32

: -001-01 : 201X-00-00

: : GMP GQP : : 9

GQP GMP

22

10 21 1021 11

GQP GMP

22 10 21 1021 11

-1

18 / 32

-1

. 1

-1

-1

3(

)

OS

PLC

LIMS SCADA ERP MRPII DCS EDMS

3 4

IT PLC

19 / 32

5.2

5. 3

5.1 5.2

5.4

GAMP

-2

2

5.5

GMP (1) (2) (3)

20 / 32

DQ,IQ,OQ,PQ

5. 6

GMP (1) (2)

(3) (4)

5.7

-3

5.7.1

5.7.2

5.7.3

5.7.4

21 / 32

-3

No.

3 4 5

( )

/

DQ

IQ

OQ

PQ

OQ PQ

5.7.5

5

DQ

5.7.6 (1)

5.1 (2)

5.2 (3)

5.3 5.7.7

22 / 32

5.7.8

FAT

SAT 5. .9

OQ OQ PQ

5.7.10 DQ

5.7.11 IQ

5.7.12 OQ

5.7.13 PQ

5.7.14

-4

23 / 32

-4

No

1 3 4 5

2

5.7.15

5.8

5.9

( )

.

. 1

24 / 32

.2

6.3

6.4

.

-5

5.5

GQP GMP

.

8. 1

25 / 32

8.2

-5

No.

3 4 5

( )

/

DQ /

IQ /

OQ /

PQ /

GQP/GMP

( ) ( )

26 / 32

. -Cxxx-01 GQP GMP

. -Cxxx-01 GQP GMP

201X-00-00 Ver. 1.0

:

:

:

27 / 32

: -001-01 : 201X-00-00

: : : :

( 22 l0 21

1021

11 ) (GXX-001-01)

(1)

(2)

(3)

(4)

(5)

(6)

(7) ( )

(8)

(9)

.

3.1

3.1.1

3.1.2

(

)

3.1.3

3.2

3.2.1

)

( ) 4.1.2

28 / 32

3.2.2

( )

3.2.3

3.2.4

3.1.2

,

3.3

3.3.1

3.2.l

,

3.3.2

3.2.1

3.3.3

(Service Level Agreement: SLA)

3.4

3.5

29 / 32

3.6

3.6

3.7 ( )

( )

4.8

4.9

1 1

4.10

1 1

5.

30 / 32

6.

:

201X-00-00 Ver. 1.0

:

:

:

31 / 32

(1)

(2)

(3)

(4)

(5)

6

(1)

(2)

32 / 32

1-8-2

3-2-5 5

1-12-29

1-2-40

1-30-3

1-5-51

2-5-8

3-2-2