Qualify the HPLC software?

[zheyin]

Our HPLC system is due for annual PM/qualification.
In order to make it fully complaint of GMP,
do I also need to have Empower 3 workstation qualified annually?
It's been installed one year ago with IOQ and AQT on the software.
Please share your experience if you are in a GMP lab. Thanks

[JGK]

Our HPLC system is due for annual PM/qualification.
In order to make it fully complaint of GMP,
do I also need to have Empower 3 workstation qualified annually?
It's been installed one year ago with IOQ and AQT on the software.
Please share your experience if you are in a GMP lab. Thanks

I only have GLP experience but you should Have SOPs in place for this type of annual qualification. Minimally you need to check:
Pump flow accuracy (set vs actual)
Oven temp across working range (set vs actual)
Sample compartment temp across working range (set vs actual)
Using a standard method check
Injection reproducibilty (across full injection volume range)
Detector wavelenght accuracy
Dedector linearity

For the software, if the vendor installed and qualified the software they will have done so on the unconfigured software (all user selectable options off). To be fully CFR part 11 compliant, once you configured the user selectable options on the software to fit your facility's requirements you should have run additional OQ test scripts to test these selections were functioning correctly. This would be done prior to allowing the instrument into the working environment.

For the software qualification we would rerun these additional scripts to confirm the same result as the initial testing.

[Gremlin76]

If you are following Waters documentation and recommendations, your data systems should be requalified every "12-15 months". Waters qualification documents also provide reccomendations for qualification considerations following repairs. You'll need strong justification from your own SOP's or other documentation if you're not following Waters recommendations. We operate in a GMP environment and the software part of HPLC systems have always been considered just as critical as the equipment for routine maintenance and qualification. In the end make sure you have a clear SOP that states what you should do and follow it.

To be clear, fully compliant with GMP goes well beyond routine qualifications. SOP's, change control, routine maintenance, qualifications, IT infrastruction, operator training and qualification, and 21 CFR 11 compliance are just parts of what it takes to be fully GMP compliant. Unfortunately any one of these parts is a discussion to itself.

My experience is - use and follow Waters (or some other qualified company) recomendations for maintenance and you'll minimize your risk in this one area.

Thanks
sTeven

[aceto_81]

sTeven,
just curious, what is included in the annual software validation?
Is it just a verify files, or do you run every year the software AQT?
Do you test system policies every year?

Thanks

Ace

[zheyin]

A follow-up:

I talked to Waters,
their recommendation is:
The software is AQT'd upon installation;
Needs to be qualified whenever there is upgrade or changes.

[venugopalv]

i have two queries,
1) what aspects/criteria are applied for periodic requalification
2) in a scenario of reinstallation of server application, what aspects to be re-qualified....
is it adequate to perform OQ?

[Johnny Rod]

Something like the Waters AQT (automatic qualification tool) is great because it does IQ (file listing) and also OQ (by running example data through processing and reporting functions). If you don't have something like that in your CDS then use a set of data and reprocess this one each time to show the results are the same (using the same method).

For server reinstallation you have a much bigger job. You need to IQ and OQ both the hardware and software, and you should do some or all of your original validation (the parts relating to the central server, not the parts like instrument control by acquisition servers for example, as these should not be affected). I would suggets that at least you shodl validate the security settings and disaster recovery parts as a database must be secure and robust, or it's worthless.

[dimitrije]

Is it really necessary to performe qualification of Empower nodes (LACe-s) and PC Clients on annual basis, or is it enough to have a server qualified?

[DR]

1) If your SOP calls for annual qualification of LAC/Es and fat clients, then you need to do it.
2) If any significant changes are made to same, it's a good idea to do it.
3) One major reason we like the client/server (enterprise) version is that we need only requalify Citrix servers after major upgrades. For adding ICS and the like, we just generate fresh checksum files after such installations (verify files).