Im on a finished product warehouse, and we have some hum/temp sensors (dickson, elpro). We use standard software from datalogger maker to get the data from the dataloggers, and we’re planning to validate this software.
What should be our approach?
Also, we use a excel spreadsheet to calculate the Mean Kinetic Temperature (MKT) and to keep a record of hum/temp lectures, we have no macros here just formulas,
Should we also validate these spreadsheets?
Thanks a lot for your help.
[quote=rockdrigo]Im on a finished product warehouse, and we have some hum/temp sensors (dickson, elpro). We use standard software from datalogger maker to get the data from the dataloggers, and we’re planning to validate this software.
What should be our approach?[/quote]
Intended Use - Part 11 Assessment - Validation Plan - URS/FRS/IQ/OQ/PQ etc, this is a very broad question can you be more specific?
[quote=rockdrigo]
Also, we use a excel spreadsheet to calculate the Mean Kinetic Temperature (MKT) and to keep a record of hum/temp lectures, we have no macros here just formulas,
Should we also validate these spreadsheets?
Thanks a lot for your help.[/quote]
Check out this link, it should help.
http://www.askaboutvalidation.com/featured_articles_expanded.php?uid=34
Rgs
Intended Use - Part 11 Assessment - Validation Plan - URS/FRS/IQ/OQ/PQ etc, this is a very broad question can you be more specific?
We use the software to get the data out of the sensors, later we use a excel spreadsheet to calculate means, average and the MKT.
Were planning to validate using GAMP, im not that experienced so I want to get some hindsigths from more experienced people.
From a validation point of view you need to prove that this software is transferring the data correctly from the loggers then validate the spreadsheets to ensure that the corrections are perfomed correctly.
You can contact me directly, if you need some consultancy work performed to help you with this project.
rockdrigo you have not told whether you have received any confirmity certificate from the vendor who has supplied the data logger. the other questions are,
is the down loaded data saved in excel.(do you extract the data for calculation)
is the data saved in a read only format of the acquisition software.
do you have the option to save the data in the excel form and the data logger software format (dual option).
let me know this i shall tell you more.
rockdrigo you have not told whether you have received any confirmity certificate from the vendor who has supplied the data logger. the other questions are,
is the down loaded data saved in excel.(do you extract the data for calculation)
is the data saved in a read only format of the acquisition software.
do you have the option to save the data in the excel form and the data logger software format (dual option).
let me know this i shall tell you more.
No confirmity cert was puchased w the loggers,
We save the data in excel,
no saving in read only format,
yes we could save both formats.
Thanks a lot!
[quote=gokeeffe]From a validation point of view you need to prove that this software is transferring the data correctly from the loggers then validate the spreadsheets to ensure that the corrections are perfomed correctly.
[/quote]
That seems to be tricky, how coul I prove data transferred is rigth?
from an OQ point of view?