Chromatography Forum

Hello all. I was hoping some other folks have had to explain/justify keeping the handheld control module from Agilent. Since you can do injections without traceability it is now being said that's a compliance risk by several agencies and clients alike. I am trying to put together a justification as to how to mitigate this risk. Thanks for the help in advance.

If there is no traceability then it would be obvious in LIMS that the injection was made that way, otherwise it would be traceable back to a data system. Seems the lack of traceability would in itself be a security protocol for securing data that is reported.

If it is just that they want to trace every injection, even ones that might be done during trouble shooting then that might be a problem, but the autosampler I believe has an internal injection count that keep track of how many injections are made, and that can be reconciled against injection logs to show if any were made on the hand held, and if the injections on the hand held are recorded in the instrument maintenance log and they total injections agree with the sum then that would be a way to trace them.

Not just the Agilent gameboy pose this risk. I believe every LC/GC that has an on board interface allows for this as companies make the equipment for every industry not just regulated ones! For example the Waters 2695's allows you to inject from its interface. They make them so that they can still be fully operated independently from a computer system as not everyone needs computers/regulation.

It may be more important that your company has an SOP dealing with this explaining the on board controllers use with what is allowed and what is not. At least with the Agilent design you could always choose to unplug the gameboy to disable the analyst from using it as an unreported injection device! The same can't be said for other equipment I've used.