We are currently looking at the possibility of purchasing an Agilent 1100 LC system for use in a cGMP environment (possibly two LCs.) We have other 1100 systems in our lab which use the ChemStation software, but none are used for cGMP, so I don't have a lot of experience with the software used for Part 11 compliance. From the info on the Agilent website, it appears that one can use the ChemStation Plus or Cerity. I've not heard much about Cerity, so I don't have an opinion about it. From previous messages, it appears that the ChemStation with SecurityPack is difficult to work with. Is Cerity any better? Does anyone have an opinion on which would be the best choice?

Anonymous,

We also use ChemStation (Rev.08). We have 4 stand alone pc's each coupled with two LC-DAD systems. We asked Agilent about the possibilities to create a network. They now selling ChemStore and ChemAcces. They advised us to buy ChemStore with a Securitypack. They also told us they are now creating Rev.10 and 11. After three years from now they are putting ChemStation, ChemStore and Cerity in one software system. They advise to use Windows XP.

Durk

FYI for Durk,

Cerity is in no way related to Chemstation (other than being made by the same company).

We use Chemstation and Chemstore A.09.01. The only real differences are the steps to get into the Chemstation software. For example, when coming in any morning, opeator must log onto Windows 2000 (we use a shared Win2000 password). Then the operator must log onto Chemstation using his own password (administrator can only clear operator's password, doesn't know what it actually is). Then Chemstation operates normally and data is automatically, transparently, un-alterably saved in a Chemstore database. The Chemstore Review Client portion is used to create "studies" which are essentially folders for different types of assays , to administer users, and retrieve data, and usually accessed only by administrators. For us, by far the biggist pain in the butt is the frequent password-entering required by 21CFR11.

We use Chemstation and Chemstore A.09.01. The only real differences are the steps to get into the Chemstation software. For example, when coming in any morning, opeator must log onto Windows 2000 (we use a shared Win2000 password). Then the operator must log onto Chemstation using his own password (administrator can only clear operator's password, doesn't know what it actually is). Then Chemstation operates normally and data is automatically, transparently, un-alterably saved in a Chemstore database. The Chemstore Review Client portion is used to create "studies" which are essentially folders for different types of assays , to administer users, and retrieve data, and usually accessed only by administrators. For us, by far the biggist pain in the butt is the frequent password-entering required by 21CFR11.

ChemStation Plus consists of ChemStation that does the acquisition/processing and some reporting, with ChemStore, which is the database that stores all the data and the optional Security Pack, which gives a "secure" system and meets the requirements of 21CFR11. ChemStation is currently on rev 9.x and ChemStore on rev 2.x. I understand that new full point versions (10.x, 3.x) will be out later this year. ChemStation Plus is an established product, with a large user base and support for all models of Agilent HPLC/GC/CE. The main issue we have with it is that ChemStore and the Security Pack were devised to provide 21CFR11 compliance for ChemStation users, which creates a hybrid product that can be tricky to use and it is not always clear why new result versions have been created. Also, because it needs to be backwardly compatible and is used by people who don't need 21CFR11 compliance, some of the functionality in that respect is not as felixible as you might need. Agilent have said that ChemStation Plus will be developed (i.e. new versions will be released) for at least 5 years, so there will be at least 10 years support for it.

Cerity is Agilent's all-in-one Next Generation CDS and will eventually completely replace ChemStation. It was built from the ground up, i.e. doesn't use code from ChemStation (though is is apparently compatible with ChemStation data and I believe uses the same algorithms for integration, etc.) and is an integrated product. This makes acquisition/processing/storage/reporting much easier (similar to other CDS packages like Waters Millennium, Dionex Chromelion? and others). Cerity version 2.x has just been released and now has support for DAD, though I understand that some parts of the spectral analysis are not yet included. I also do not think it has support for the older Agilent models (1050/1090 HPLC, 5890 GC, etc.) yet.

Both systems have their good and bad points. The best thing you can do is to see if Agilent will either give you a long demo of each, or even better let you have them on loan. Always remember that the opinions you get from posters will be usually biased towards the negative aspects of each package, whilst sales reps will show the positive.

WE use Turbochrom Version 6.0

Cerity is very locked down and difficult to use. I would suggest a demo. We could not use it because it would not allow cross calculations (if the sample were not run in the same set.