ii

.1

...3
3
(1) .....3
(2) ....3
..4
..4
(1)
4
(2)
5
.5
.6
(1)

(2)

...7

(3)

...7

8
...9
9
9
(1)

.....10

(2)

....
10
.....

(3)
10

.12
..12
iii

..13
..13
.14
.14
.14
.14
.15
..15
16
1 ...16
2 ...18
(1)

.18

(2)

.18

(3)

.18

(4)

.19

(5)

.19

(6)

.20
1. ..20
2. ..21
3. ..21

3 .22

pH .23

24
..
..28

31
..
iv

..34
...39

88 5 1
18

88 4 13

(1) :

(2)

(1) :

(2)

(1)

MS-DOS UNIX

Lotus 1-2-3

(2)

(3)

(1)

(2)

(3)

10

11

(
)
()

2
/

12

13

8
14

15

16

(1)

(2)

(3) EPROM

(4)

17

(1)

(2)

1.
2.
3.

(3)

1.

18

2.
3.

4.

(4)

1.

2.

3.

(5)

4.

5.

6.

1.

2.

19

3.

(6)

1.

:
(1).

(2).

(3).

(4).

(5).

2.
20

(1).

(2).

(3).
(4).
(5).

3.

21


pH
pH

1.

2.

pH

3.

4.

22

1.

2.
,

2-1

2-2
23

2-3

3.

3-1

3-2
3-3
3-4

4.

4-1

4-2
4-3

24

4-4

4-5

4-6

5.

6.

6-1

6-2

6-3

25

6-4

6-5

6-6 /

6-7

6-8
6-9

26

1
1
(1)
(2)
(3)
2
(1)
(2)
(3)
(4)
(5)
3
(1)
(2)
(3)
4
(1)
(2)
(3)
(4)
5
(1)
(2)
(3)
(4)
6
(1)
(2)
(3)
(4)
7
(1)
(2)
(3)
(4)
(5)
27

(6)
8
(1)
(2)
(3)
(4)
(5)
9
(1)
(2)
(3)
(4)
10
(1)
(2)
(3)
(4)
(5)
11
(1)
(2)
(3)
(4)
(5)
12
(1)
(2)
(3)
(4)
(5)
(6)
13
(1)
(2)
(3)
(4)
(5)
(6)
14
(1)
28

(2)
(3)
2
1
(1)
(2) /
2
3
(1)
(2)
4
(1)
(2)
(3)
(4)
5
(1)
(2)
(3)
(4)

29

1
1
2 GMP
3
(1)
(2)
4
(1)
(2)
(3)

2
1
2
3
4

3
1
(1)
(2)
(3)
(4)
(5)
2
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
3
(1)
(2)
30

(3)
(4)
4
(1)
(2)
(3)

4
1
(1)
(2)
(3)
(4)
(5)
(6)
2
(1)
(2)
(3)
(4)
(5)
(6)
3
(1)
(2)
(3)
(4)
(5)
(6)
(7)
4
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
31

5
(1)
(2)
(3)
(4)
6
(1)
(2)
(3)
(4)
(5)

5
1
(1)
(2)
(3)
(4)
(5)
(6)
2
(1)
(2)
(3)
3
(1)
(2)
4
(1)
(2)
(3)
(4)
(5)

1
1
(1)

32

(2)

(3)

(4)

2
(1)

(2)

(3)

3
(1)

(2)
I/P

2
1
(1) CPU
(2)
(3)
(4)
(5)
2
(1)

(2)

(3)

(4)

(5)

3
1
(1)
(2)
(3)
(4)

2
(1)

(2)

3
(1)
(2)
(3)
(4)
33

(5)
(6)
4
(1)
(2)
(3)
(4)
(5)
(6)

5
(1)
(2)
(3)
(4)
(5)

4
1
(1)
(2)
(3)
2

5
1
(1)

(2)

(3)

(4)
2
(1)
(2)
(3)
(4)
(5)

6
1
(1)

(2)

34

(3)
2
(1)

(2)

(3)

3
(1)

(2)

(3)

4
(1)
(2)
(3)
(4)
(5)

5
(1)
(2)
(3)
(4)
(5)
(6)
6
(1)
(2)
(3)
(4)
(5)
(6)

7
1
(1)
(2)
(3)
(4)
(5)

2
(1)
(2)
35

(3)
(4)
3
(1)
(2)
(3)
4
(1)
(2)
(3)
5
(1)
(2)
(3)
(4)
(5)

(1)
(2)
(3)

(6)
6
(1)
(2)
(3)
(4)
(5)
(6)
7

36


(Acceptance criteria)

(Access control)

(Analog)
0 1
(Analog Data)

(Application software)

(Batch testing))
(Boundary value)

(Branching test)

(Change control)

(Commissioning)
(Computer system)

(Computer-related system)
37


(Computerized system specification)

(Computerized system)

(Computer-related system validation)

(Configurable software)
Excel
(Controlled function)
(Critical process parameter)

(Data integrity)

(Default value)

(Design specification)
(Digitalized Data)
/
(Embedded program)

(Environmental factors)

(Final Data)
38


(Firmware) EPROM
(Firm acceptance test, FAT)

(Functional requirement)

(Functional specification)

(Functional testing)

(Installation qualification)

(Laboratory data acquisition system LDAS)

( Life cycle)
(Module)

(On-going evaluation)

(Operating environment)

(Operating system)

(Operational qualification)

(Packaged system)
39


(Path testing)
(Performance qualification)

(Policy)
(Process)
(Processed data)
(Process validation)

(Program listing)
(Programmable logic control, PLC)
(Real-time testing)
(Resources allocation)

(Security control)

(Source code)

(Standard operating procedures, SOP)

(State of control)

(Statement testing)
40

(Structural verification)
(User)
(Vendor) deliver

Computerized System. Guide to Good Manufacturing Practice for Pharmaceutical

Products. Pharmaceutical Inspection Cooperation Scheme.May 1992

Guide to Inspection of Computerized Systems in Drug Processing. U.S. FDA (Feb.

1993).

Validation of Computer-related Systems. PDA Technical Report No. 18 (June 1995).

Validation and Qualification of Computerized Laboratory Data Acquisition Systems.

PDA Technical Report No. 31 (June 1999).

Huber L (1995). Validation of Computerized Analytical Systems. Interpharm Press,

Inc., Buffalo Grove, Illinois, U.S.A..

21 CFR Part 58.190. Good Laboratory Regulations. U.S. FDA.

In Microsoft Computer Dictionary 4th Ed. (1999). Microsoft Press, Redmond,

Washington, U.S.A. [ 2000].

41