The Agilent - Waters control code exchange agreement was (as far as I am aware), the first of it's kind. How everyone else offering "control" of another vendors HPLCs i.e. full HPLC control of all instrument parameters that the HPLC vendor themselves can control, plus acquisition, analysis, calculation and reporting in a manner which meets *their* interpretation of 21CFR11, does it, I am uncertain of.

My questions are aimed at those who have cross-control setups in place (i.e. HPLC controlled by another vendors CDS) and to get some opinion on the "officially sanctioned" control being (or to be, in the case of Cerity for Pharma - will it ever appear?) offered by Waters and Agilent.

First, if something goes wrong, who do you call to sort it out? One of our concerns is over the potential blame culture that this "hybrid" system can engender. Plus of course the potential lack of diagnostic functions available when someone does come in.

Second, if the hardware vendor brings out a new module for their HPLC, or upgrades the firmware installed on their modules, what do you as a user, or the vendor of your CDS, do to ensure that you still have full control of your HPLC?

Third, what feedback have other evualtors of Waters/Agilent CDS-HPLC, had over the continuation of the agreement for the foreseeable future. We have heard that the agreement is ratified annually, but that just means they only have to continue with it for another year and could pull the plug when it comes to renewing it again (though they claim that this wouldn't make any sense for either of them...).

Thanks

There are 2 ways for a software vendor to control a peice of hardware. The best way is to have an agreement in place and trade code (the Waters/Agilent agreement of which you speak). Under these agreement both parties agree to trade code, provide information, keep each other updated on firmware revisions, provide instruments and support and generally play fair. The other way (a much more popular way) is to reverse engineer the instrument control code. Of course doing it this way you have a zero level of support for the hardware vendor. They bring out new firmware, hardware or whatever you are on your own.

Who do you call when something goes wrong? A good question, hardware problems - call the hardware vendor. Control problems - call the software vendor. Don't know what youve got, call one, if they cant (wont) help you, call the other.

As far as the exact nature of the agreement between Waters and Agilent, who knows? I am guessing that if you really needed to know this information, either party should be able to provide the details (maybe only if a sale was on the line).

We have 1100's controlled by Millennium and I am not a fan of the setup. The instrument control does work but has many limitations. Specific instrument errors are only reported as general instrument errors by Millennium. Millennium cannot run diagnostic tests or 1100 OQ/PV tests. There is no support for diode array detectors or spectral library functions.

There is a lag between the release of new firmware for the 1100 and Millennium support for it. On the usability side, a Millennium instrument method is configuration specific. Thus if you have different 1100 detectors, thermostated autosampler, switching valve, etc. you need a different Millennium instrument method for each configuration.

On the compliance side you will need to think about how you are going to qualify the system. Agilent will use a portable ChemStation to qualify the 1100 if you call them in. However, this is not how you will be using the system. You will have to decide how compliant this is.

For a regulated lab I still think level 4 control is more valuable than a standardized CDS. I think any company wide standardization should be downstream of the chromatograph.

I am currently re-writing the 1100 OQ/PV to use Millennium instrument methods and processing. If anyone else has already done this and can save me time please let me know. If anyone wants this once I have finished I can post it for download.

Thanks for the responses so far.

In response to Tom's query, I am aware that Waters have put together a PV for qualifying 1100s through Millennium. You can contact them to see exactly what they do, but I believe it is similar to what they already offer for the Alliance qualification.

Hi Tim,

I have run the Waters Millennium/1100 PV. I guess it is ok as a performance verification. It uses a single concentration of a four component standard and calculates precision of replicate injections and linearity from 5-20ul injections. It is not a very complete test as it is supposed to be run after an OQ. Waters does not have a Millennium/1100 OQ procedure.

I need a complete OQ that will be run annualy following a PM. Flow accuracy, gradient linearity and accuracy, dwell volume, injector precision and linearity, detector noise and response lnearity, column heater accuracy, sample cooler accuracy, etc. Basically I need the Chemstation/1100 OQ/PV ported to Millennium/1100. Thanks.