does anyone have experience of Millenium 32 version 4, Chemstation plus and Dionex Peaknet/Chromeleon software in a networked 21-CFR-11 compliant environment? I would like a usrs comparison prior to commiting to purchasing a new CDS.

I have used both Millennium 32 and Chemstation. I have found Millennium to be the superior software package. The interface is generally more intuitive, data is presented better, and (while this might be hardware related) the system is more stable. I've run into many problems with Chemstation crashing during runs, affecting data collection; not so with Millennium (knock on wood). Installation of Millennium is easy, validation is layed out in a step-wise manner within the manual, and security is tight. Just my opinion. Hope this helps.

I am in charge of a large networked 21-CFR Agilent ChemStation Plus system and have no problem with it.
I think you might consider Agilent, Waters, Thermo-Labsystems and Dionex.
One key point in your choice is what instruments you have to connect (HPLC only or GC also, one or many brands, old and new systems ...).
If you have a great variety, you may consider a generic CDS like Thermo-Labsystems ATLAS or Dionex CHROMELEON (although Dionex sells HPLCs, their CDS is "open").
If you are HPLC and Waters oriented, Millenium will be fine.
If you already have Agilent instruments, I would recommend you to wait a few weeks for the new Agilent CERITY for PHARMA (available in January 2002).

Agilent CERITY for PHARMA (available in January 2002) - do you mean revision A.09?

No, while continuing to develop ChemStation family (i.e. rev A.09), Agilent is about to launch a completely new product dedicated to QC activity in regulated pharmaceutical environment.
This will be the second product of the Cerity family (a "Cerity for Chemical QC" is already available typically for GC in petrochemical QCs).
You may have a look at their site http://www.chem.agilent.com under Information Management.
PS : I am not with Agilent, just a customer.

thanks for the info. I have seen the Waters, Agilent,and Dionex software. Dionex is easy to use but have been advised that not so compliant. Will assess Atlas next week.

All I can add to this discussion is a word of advice. Colin, if you decide to go with Chemstation, make the sales rep show you step by step how to use the SW in a compliant fashion (before you buy it) or you will be sorry. I am sure that the rep will tell you that it may be a little hard to use, but don't worry, Cerity is coming soon (they have been using that line for the past couple of years!). As the joke goes, all are looking forward to the 3rd annual release of Cerity at Pittcon 2002. :~)

Good Luck

Although I said I have no problem with ChemStation Plus, I agree with Droid's opinion.
When time came to get in complance with CFR, all our GCs and HPLCs (a dozen of each) were from HP/Agilent and equipped with ChemStation, so two years ago we "naturally" went to ChemStation Plus.
The product is complete, stable, rather easy to administrate and well serviced.
But as Droid said, not very straightforward to use in a totally compliant manner; this is why I made advice to Colin to wait for Cerity if he wants to go with Agilent.
Unfortunately Cerity for Pharma has already been delayed several times. I have seen the product last summer and indeed it was not totally stable at that time; I hope for Agilent and their customers that the product will be available next January as promised.

I am faced with a balance of system control (of TSP and waters equipment) Vs Compliance capabilities at present. I have been advised by a consultant that Waters Millenium 4 is technically the most compliant, followed by Agilent. Have seen the Dionex software and its clearly a very simple to use piece of SW, however there are issues concerning compliance. Has anyone else evaluated the various SW for levels of compliance readiness? CFR-11 seems such a moving target that it seemms like every vendor has interpreted its rules in a different way. Obviously, the FDA will not rule openly on who is the tightest in terms of compliance.

I have no experience with Dionex; my opinion is that Millenium 4 and ChemStation Plus both provide the necessary tools and environment for compliance, provided you use them in an appropriate manner.
Then comes the ease of use ...
Control of instruments is an important issue from compliance and reliability points of view. Let me take an exemple : if your HPLC detector settings are note "engraved" in a protected global method, a change of the time constant/noise filter that may alter the Limit Of Detection of your validated method will be possible and will never be seen/reported by the CDS.
Unless you are in the "ideal" situation where all your instruments are of the same brand as your CDS, and recent enough to be totally controlled, you will have to make compromises and to use procedural workarounds to deal with this issue.
Another point to consider : "foreign" instrument control can be established in two ways : 1)using the original source code 2) retroengineering; of course 1) is better and 2) is almost impossible to validate.
I do not think generic CDS makers like Dionex or ThermoLabSystems (Atlas) have got any source codes (even Atlas for TSP instruments that come from another subsidiary or Thermo!).
Due to customer pressure, Waters and Agilent have exchanged codes for Alliance and 1100 (not including DAD and MS); but Waters' claimed control over Agilent GCs is retoengineering (from what I know).
Some customers have requested Waters and Agilent to get control of Thermo HPLCs; I have no idea if one of them will succeed in getting the source codes.
My overall opinion is :
* if you have Agilent GCs and Waters Alliance and TSP HPLCs, consider Agilent Cerity (when available! ChemStation is not for future ...)
* if you have no GC and only Waters and TSP HPLCs, consider Millenium.
In both cases you will have to set up procedural control for TSP and you will remain free to replace TSP with either 1100 or Alliance in the future if Thermo does not make their codes available.

We have 20 HPLCs, a mix of Waters Alliance and Agilent 1100s. We were running all Alliances with Millennium32 and all of the 1100s with ChemStation Plus. We have recently migrated all 1100s to Millennium32. Here is what I have learned.

I would not trade level 4 instrument control for the sake of a common data system. Millennium32 is the best software for the Alliance and ChemStation is the best software for the 1100.

ChemStation has much better instrument OQ/PV and troubleshooting support than Millennium32. ChemStation is a 16 bit application and has stability issues when run on a modern 32 bit OS. Agilent has had difficulty staying on top of memory leaks, sometimes point releases have reintroduced memory leaks that had previously been fixed. If running ChemStation buy lots of memory and restart periodically.

Millennium is a more powerful software application, however, many functions are several screens deep and it does seem to take analysts longer to get comfortable with the software.

Due to being built on top of Oracle, Millennium32 has a large hardware and administrative overhead.

Before buying Millennium32 explore technet.oracle.com and look at recommended server hardware, recommended disk configurations, and backup strategies. While you are there sign up for some DBA training :-)

Waters will sell you Millennium loaded on a single disk PC but Oracle is NOT a desktop application. If you are currently running other "enterprise" software built on top of Oracle and have in-house DBA expertise that you can leverage, Millennium32 is a fine application. However, I have seen a few installations that are an absolute disaster waiting to happen.

I played with a pre-release version of Cerity so I cannot comment on it much. It is built on top of an object oriented(OO) database. I think this was done to reduce the overhead that Oracle forces you into. However there are non trivial object relational mapping issues when using an OO database. It will be interesting to see how Agilent has solved or worked around these.

If I were setting up a new lab today I would go with 1100s and ChemStation and put the database futher downstream (LIMS or Laboratory Resource Planning). Good luck.

Thanks to all who contributed to this interesting thread. Most of the comments parallel my own assessment of the current CDS market situation, but I'd like to set the record straight on a couple of points.

Colin, I don't know the origin of your consultant's opinion about the compliance-readiness of Dionex software - perhaps he or she was only familiar with the older PeakNet 4 or 5. The Chromeleon software, which is also sold into the IC market under the PeakNet 6 name, is fully 21 CFR 11 ready. I'd suggest that you check out Dionex Technical Note 54, a 16-page document that systematically details the compliance aspects of the software. You can request a printed copy, or if you don't mind the screen images being a bit fuzzy, you can download a PDF version from the Dionex Web site (there's a link at the bottom of the page http://www.dionex.com/app/tree.taf?asset_id=12451).

Regarding control, Chromeleon offers full control of Agilent 1100s, 6890s, and 5890s, ThermoFinnigan Spectrasystem LCs, and many other LCs and GCs. Control software was developed using protocols published by the respective suppliers. Waters pump control is available today through a pump control card, but full control of Alliance systems is probably a year or so down the road.

An integral database is extremely valuable for tracking samples and collating results, if implemented well. Oracle is very secure and fault-tolerant, but it definitely carries a lot of administrative overhead, so it's only practical for large multi-user installations. Because Chromeleon's database functions are implemented via ODBC, any ODBC-compliant database platform can be used. The software is validated with Oracle, MS SQL Server, and MS Access back ends.

Having worked many years in chromatography software marketing, I have plenty of additional information, including customer references, but it's not appropriate to post such material here. Please contact me offline if there's anything I can offer to help you arrive at the best solution for your needs.

I really have to disagree with the following statement from the previous message. "Oracle ..., so it's only practical for large multi-user installations." This is an absolute myth. Small multi systems (4-5 LC's, and a couple of users) or even single systems with a single operator function very well on Millennium32 with its Oracle database. The database is embedded so the user really dosent even know its there. The administrative overhead only really begins when you move into the larger client server installations (up to 100's of LC's and users). And of course this overhead impacts any CDS from any vendor in these large systems. The lab I previously worked in had 4 seperate LC systems and 3-6 users (depending on the number of post docs around) running on 4 seperate Millennium32 systems. I don't recall any extra overhead to administer the database, it was just there and did its job.

Just another 2 cents worth.