Chromatography Forum

Dear all,
I work in a quality control lab. of pharmaceutical industry. One of our 1100 agilent HPLC is conected to an old PC that now must be replaced with a new one. Agilent ask us about 2000 euro to reinstall Chemstation (standalone version, without Chemstore) and perform a new IQ/OQ of the software.
What is your opinion about this ? Is it a right price or it seems a little higher ? Do you perform IQ/OQ of software yourself ?
Thanks

Hi GT

I can't comment on the price as our installs are covered by our support contract.

For our systems we had Agilent do their IQ/OQ to give proof that they have installed it correctly and that it is working to the manufactures specification.

We then ran our own scripts to ensure that the functionality we use is working the way we want to use it and is compliant with the appropriate regulations.

Hope this helps

Hi GT,
2000 euros is the price for their job (is travelling cost included ?). You certainly may save 1000 euros for your employer by installing ChemStation on new PC yourself - remaining 1000 euros would be nice prize for you from employer

Is it A or B version of ChemStation ? In fact it's not too difficult to install this software, provided you have license numbers handy (you probably have them on self adhesive stickers attached to one of 1100 modules).

As to IQ/OQ....

a) IQ is much easier than software installation itself: press Start button, Programs, ChemStations, Installation Qualification and after a while of analysing files nice ChemStation Installation Verification Report will be ready for printing

b) OQ ????? I haven't the faintest idea whether it is performed after ChemStation installation. Always thought it's performed rather with hardware not software.


BTW - is your company obliged to have CDS installations performed by manufacturers reps ? If no, you have nothing to loose installing it yourself.

(or just send me 1000 e and I'll come and help you to print IQ report - you don't have to treat this seriously - only joking)


Wojtek
Sz-n, PL

As you are only using Chemstation, you may not have to be GLP/GMP, but if you are, then the person performing the IQ/OQ/PV must have documented training to show they are competent to perform the task.

If you are audited by a regulator or client, one of ther first things they will ask for evidence that the people who performed instrument and software installation were qualified to do so. That means that when the Agilent installer gives you the documentation, he/she will include a copy of their training record. As with all quality stuff, it's the pieces of paper that create expense.

If you can save a 1000 Euro, that's good, but first make sure that you don't need to be compliant with any form of cGxP. Also, ensure that you have a good relationship with Agilent, because if you have subseqiuent problems and call them in, they may want to repeat the install before any problem solving....

Bruce Hamilton

Dear all,
thanks for your hints, now I would like to add some datails to go deeper into the problems.
Scottie What are "our own scripts", are they the macros that you use in calculations ?
dblux I know about automatically IQ of software and so we perform routinely this check once for year, about OQ it's the verifications of possiblity to change the method with "manager" profile, the impossibility to do it when log as "operator", the functionality of access by password (after set this option) and then the execution of about 15 files with extension .val for the verification of correct elaboration of raw signal.
Bruce Unfortunatly we have to be cGMP, we are using only chemstation (and not Chemstore, security packor so on...) but togheter with some SOP to guarantee the security, traceability ... . Are people from IT qualified "for definition" to perform this kind of test ? If these tests are performed and documented by them do you think thata some autority can make some observations ?

I'll wait for your kindly reply
by

GT:

possibility of performing OQ/PQ tests is done by your SOPs. If your SOP is written in such manner, you can perform these tests yourself. It is easy routine - just run several .val files and check whether the test results are PASS. Our company have own documentation.

Installation of CHS is quite simple procedure and may be performed by average IT skilled person. Please be careful and note comunication settings and license numbers. If you are using GPIB interface note settings of SICL (detailed description in installation manual). If you are using TCP/IP note communication address and mask.

Regards

Bruce Unfortunatly we have to be cGMP, we are using only chemstation (and not Chemstore, security packor so on...) but togheter with some SOP to guarantee the security, traceability ... . Are people from IT qualified "for definition" to perform this kind of test ? If these tests are performed and documented by them do you think thata some autority can make some observations ?
by

In my opinion, you're doomed. If you have to be cGMP compliant, you are not going to pass any diligent audit of your systems by just using Chemstation without another carefully-designed layer of data security.

The second reason Agilent sells Chemstore is because Chemstation alone can not be made cGMP compliant, the first reason is obviously to try and make money...

One requirement of 21CFR is that the original data must be available and untouched, and Chemstation permits manipulation and even deletion of the data. We were told by the local Agilent people that they would not even pretend the Chemstation software was compliant.

If your management don't believe this, or Agilent's documentation, request a review from a cGMP consultant that specialises in laboratory systems for cGMP.

Also, I highly recommend visiting Huber's www.labcompliance.com site, as he conveniently offers lots of hints on Agilent software, along with abstracts of the FDA reports on laboratories that have issues.

If you are going down this path with Chemstation, I wouldn't worry about paying for Agilent to install your Chemstation, just document what is done, follow the easy instructions in the mnauals, and let anybody perform the install. It's going to be the least of your problems in an FDA or Client audit.

Please keep having fun,

Bruce Hamilton