Friday, 5 July 2019

Performance Qualification of Data Logger


Performing the Performance Qualification.
Test the performance of the Data Logger as per the Check List and record these in the Performance Qualification Report. The frequency of recording results has been decided based on the results of the Operation Qualification. The test methodology is defined in the check list.
The Data Logger shall be handed over to Quality Control only after successful completion of Performance Qualification. 
Record all observations and deviations in the report. In case of deviation prepare a deviation report with justification and get it approved by Head Quality assurance, Head Quality Control.
Check list for Performance Qualification

EQUIPMENT / SYSTEM: DATA LOGGER

Test  ( S) Required
Test Description
Acceptance Criteria

Results
Checked by
To check the data scanner is functioning or not.
Plug the cord of instrument into the main electrical supply and observe  for blinking the scanner
It should  blink the scanner when it is in ON condition


To check the  all key’s (8 no.)on the data scanner are functioning or not.
When it is in ON condition check all key’s by entering any data into the instrument.
All key’s on the data scanner  should work properly.


To check the RTD probes  supplied by manufacturer for showing temperature on the data scanner.
Connect the RTD probes to the data logger unit as per method
Given in the Manual. Observe the readings on display by putting these probes into the water.
RTD probes should show temperature on the display.


To check & compare the temperature of both temperature indicator and probe are near about similar.
Fix the required number of probes to the data logger and place in autoclave at different locations and run the autoclave as per procedure and observe the temperature of both temperature indicator of autoclave and probes.
Both the probe and indicator should show similar Temperature.



Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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