Data Integrity

Discussions about chromatography data systems, LIMS, controllers, computer issues and related topics.

7 posts Page 1 of 1
Good morning everyone. Does a physical test (such as "color of solution") need double checking by another analyst?
Thanks
crimelist wrote:
Good morning everyone. Does a physical test (such as "color of solution") need double checking by another analyst?
Thanks

If you investigate according to ISO standard - do as relevant standard states.
Same if your source method is ASTM method, EPA method, SOP etc.

If none of above apply do as to obtain best results.
Depends whether some a**hole defense attorney starts screaming about it. Or whether one had a witness when he used the restroom.....
Yes, I have a problem with an inspector.
According to your MAJOR OBSERVATION, each analysis should be done by 2 analysts.
If you work in a crime laboratory then they probably require it. Just like to show a white powder is cocaine you have to run it by mass spec and FTIR, must be two different methods to confirm even though mass spec should be reliable enough on its own.

Just like with FDA, if you change the autosampler tray to a different serial number you have to revalidate the entire system because it is now a different instrument, even though the tray only moves the sample into position and has no effect on the result.

Too many lawyers and not enough scientist deciding what constitutes good data.
The past is there to guide us into the future, not to dwell in.
crimelist wrote:
Good morning everyone. Does a physical test (such as "color of solution") need double checking by another analyst?
Thanks



Maybe you could compromise. Analysts with two working eyes could sequentially check the color with each.
James_Ball wrote:
Just like with FDA, if you change the autosampler tray to a different serial number you have to revalidate the entire system because it is now a different instrument, even though the tray only moves the sample into position and has no effect on the result.


I have zero memory of doing or not doing anything so ridiculous and worrying about revalidation.

My supervisor was super-anal about stuff like whether "moving an instrument" required revalidation, like what if a GC was moved an inch on the bench to tighten a leaky fitting.

I seem to remember that we could not put an instrument on a cart to move it to a different location but could slide it over/down the bench....

Maybe the feds need to knock on my door....
7 posts Page 1 of 1

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