GT wrote:
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