VALIDATION OF COMPUTER SYSTEMS IN PHARMACEUTICAL, BIOTECHNOLOGY AND MEDICAL DEVICES INDUSTRIES

1
VALIDATION OF COMPUTER SYSTEMS IN PHARMACEUTICAL,
BIOTECHNOLOGY AND MEDICAL DEVICES INDUSTRIES

• By
• Gati Michael

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Introduction to Validation of computer systems

• What is validation
• Types of validation

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Requirements for validating computer systems

• System definition
• Software development by qualified personnel with
  written standard operating procedures
• Qualification standards (installation, operation,
  performance)
• Maintenance and change control procedures

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PRATICAL VALIDATIONScope /definition

• Operation and performance of software testing
• Acceptance criteria
• All documented activities results should be
  approved with the predefined specifications for
  acceptance

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Computer controlled fluidized bed spray-dryer and
granulator
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Review of Control program

• Source code was not available
• Control program list was available but not
  commented
• properly
• Help from team work, review of the control
  program and
• the operation of the system from Biothechnology
  
• process engineers
• Able to identify major computer controlled
  parameters and
• and how they are connected in the process
  (Process control
• technology) from the control program

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Control system design
Process
Actuators
Controller
Set point/ desired input

F
J
e

-
Controlled value (C)

• Transmitter
• Sensor
• Transducer

Measured value(B)
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Identified computer controlled Parameters

• Temperature
• Air flow
• The liquid
• Roller (disintegrator) M1

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Process control design
1 Inlet temperature Tb CFOK 0,3.0,1 // 0
analog input 013,10 possible mearsured value
(-10V-10V) 0.5,0.1,35.7 0.02197,2300.0 0.0
,110.0 // min and max value 2 T lev
KI
10

• 43 desired input
• El
• CK
• 4,301.0,0
• 0
• 0.0
• 44 17,0.427198,0.366667 44
  Temperature Controller
• 5,6.0,1
• 43,1,1
• 80.000000,1.0,80.0,20.0 P,I,D
• 0.000000,100.000000

2
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Security control
3
12
Temperature Controller 44
Security action
Controller
25 26 50
F
PID 44
43
e

-
Temperature (celcius degree)
1
13

4
14
(No Transcript)
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Air Flow Controller 33
Controller
F
PID 33
30
e

31
-
Air flow (volume per hour)
32
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Testing design and results Operation and
performance

• Default values used for testing
• Temperature
• Air flow controller
• Roller M1
• Valve control verification log
• System continous security testing
• System closing
• Overal results (Performance)

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Conclusion

• Gained validation experiences