CDS for QC lab

[GT]

Hi All,
we are selecting a CDS for QC laboratory to be compliant to 21CFR11.
At the moment we are evaluating 3 different CDS: Empower 3, Chromeleon 7.1 and Agilent Openlab with Chemstation ver. C.
Actually we are using Chemstation ver. A or B so we are more oriented to Openlab / Chemstation.
Could you please indicate, on the basis of your experience, the strength and weak points of these CDS.
Thanks in advance for help
Regards

[Csaba]

Hi,
You will have to write a serious URS! A very condensed list is:
Suitable for QC labs: all three a well suitable for an ordinary QC lab!
Future: Empower will be replaced by Unifi, so that is a drawback.
Track Record: In my opinion, support of Chromeleon is the only one I can recommend.
Quality, performance and support of the their own instrument: You can find many heated arguments in this forum about that. Write your URS and test! I believe all three has good LC hardware but, there is more than just LC...
Support of other vendors instruments: Chromeleon is superior.
Unique advantage: CE and GC-MS: Chemstation. IC: Chromeleon. SFC: Chemstation & Empower.
Easy of use: Chromeleon is superior. But in a QC lab you have plenty of time to learn Empower....
Functionality: Chromeleon is superior, but write your own URS and test!
Only Chromeleon has reports that you can copy column of data from. Something I'm very dependent on in an agile research lab and changing conditions. The opposite to a QC lab.
Then you have to consider the cost...
I’m sure others have other opinions. So it time to fix some pop-corn and lay back and read all the arguments…

[bgranot]

Hi All,
we are selecting a CDS for QC laboratory to be compliant to 21CFR11.
At the moment we are evaluating 3 different CDS: Empower 3, Chromeleon 7.1 and Agilent Openlab with Chemstation ver. C.
Actually we are using Chemstation ver. A or B so we are more oriented to Openlab / Chemstation.
Could you please indicate, on the basis of your experience, the strength and weak points of these CDS.
Thanks in advance for help
Regards

You have to weigh cost vs benifits. In this case Chromeleon and Agilent Openlab wins.
If you are oriented to Open lab/ chem station, Agilent may be the way to go.
It is worth while to check out chromeleon as well.
I have heard that Norvitis move to chromeleon from Empower due to cost vs benifits analysis.

It is also pending how long you want to keep your job. If you hate your employer and plan to leave the employer in few years, I suggest to buy the Empower, which takes long to implement. It will take about three to five years of pain and suffering of the Empower users to make your employer relize that it was your fault.
The referance for it is the Norvitis case.

Take it eazy and enjoy the ride

[Karen01]

I have no experience with Chromeleon and have not used OpenLab but have used Empower and Chemstation. The QC lab at my last company used Chemstation with Chemstore.

1) Between Empower and OpenLab, OpenLab is a relatively new product and Empower has been 21CFR11 compliant for a long time. New software tend to have more bugs and usability issues

2) I find Empower to be my put together MUCH more logically and coherently than Chemstation.

As it is all one product and was built that way from the ground up all aspects, including reporting, go together seamlessly.BTW I used it for many years to control and do data acquisition/reporting with Agilent GCs

It is essentially the same to an end user from a single isolated workstation controlling a single instrument, to client server installations

Also it is much more flexible than Chemstation can be WITHOUt having to learn a macro language.

I found Empower easy to use and learn (much easier than Chemstation which seems a hodgepodge to me), and that goes for it's reporting and export capabilities which I found to be very flexible and useful.

What I find though is that those who have used Chemstation long time tend to have hard time adjusting to Empower because it is put together so differently and uses a database not only for data but also for methods, instead of simple files.

Empower can be setup to be very automated and locked down if you need it that way, but it does take someone who understand it well to set it up that way. It's very deep package in terms of functionality so there is a lot to learn, but the logical organization makes picking it up very easy once you understand the core philosophy behind the design and teh role the underlying database plays.

After a layoff of several years I was able to step back into Empower almost as if I never stopped using it because of that

My impression of Chemstation is package that has a lot features that were added at different times without a unifying philosophy, and overlapping functionality. That's why I found it hard to learn.

BTW I have been told that Unify is very empower like.

Anyway that is my 0.5 cents.

- Karen

- Karen

[bgranot]

I have no experience with Chromeleon and have not used OpenLab but have used Empower and Chemstation. The QC lab at my last company used Chemstation with Chemstore.

1) Between Empower and OpenLab, OpenLab is a relatively new product and Empower has been 21CFR11 compliant for a long time. New software tend to have more bugs and usability issues

2) I find Empower to be my put together MUCH more logically and coherently than Chemstation.

As it is all one product and was built that way from the ground up all aspects, including reporting, go together seamlessly.BTW I used it for many years to control and do data acquisition/reporting with Agilent GCs

It is essentially the same to an end user from a single isolated workstation controlling a single instrument, to client server installations

Also it is much more flexible than Chemstation can be WITHOUt having to learn a macro language.

I found Empower easy to use and learn (much easier than Chemstation which seems a hodgepodge to me), and that goes for it's reporting and export capabilities which I found to be very flexible and useful.

What I find though is that those who have used Chemstation long time tend to have hard time adjusting to Empower because it is put together so differently and uses a database not only for data but also for methods, instead of simple files.

Empower can be setup to be very automated and locked down if you need it that way, but it does take someone who understand it well to set it up that way. It's very deep package in terms of functionality so there is a lot to learn, but the logical organization makes picking it up very easy once you understand the core philosophy behind the design and teh role the underlying database plays.

After a layoff of several years I was able to step back into Empower almost as if I never stopped using it because of that

My impression of Chemstation is package that has a lot features that were added at different times without a unifying philosophy, and overlapping functionality. That's why I found it hard to learn.

BTW I have been told that Unify is very empower like.

Anyway that is my 0.5 cents.

- Karen

- Karen

Karen,

If you want to pay $10,000 for empower license to work offline on your PC and this is without the validation
IQ/OQ, this is ok with me.
If I was your employer, it would pay me to get the other software with IQ/OQ and send you to training for a week with agilent or Dionex or others.. and financialy will be ahead of empower.
Agilent was pioneer in software validation. They even wrote 'the book'. This is before Waters even had the millenium software ( which came before empower).
The FDA was consulting Agilent (HP) software experts before they put together the 21CFR Part 11.
Do not try to give the impresion that empower has the monopoly on 21CFR part 11, because thay do not.
The reason why Empower is so big is becuase of the deception that the Empower has the monopoly on 21CFR part 11, and I hate the deceptions that was used by very pushy marketing people of Waters.
I am not working for Agilent or Dionex, and I personaly like Turbo chrom which the software was written by chromatographers not computer scientists who are not familiar with the work we do.
The last time I used Turbochrom was ten years ago, and I lerned millenium, empower, chem station EZ Chrom, Chromeleon over the years. I work with the software available given to me by my employers and do the best I can with these softwares.
You are very lucky to be able to choose the software you want to work with.
Most of us are not that lucky.
It is in our job description to lern new things every day as a scientists weather you are Sc.D.,PHD, MSc, BSc, ASc, etc....

So if you like Millenium, and you do not want to lern new things, it is ok too. I am not agaist millenium.
You will comply with 21CFR part 11, and be productive to your employer with millenium.
No one recieved 483 or worning letters from the FDA, because the FDA did not like Waters, Agilent, PekinElmer or Dionex. It is all about how you oprate these softwares.
The FDA does not want to get into this debate, and tell you which software to buy. This is all your decision.
I just wanted you to be more objective like a scientist.
Be happy, because you can choose.

[Karen01]

If you want to pay $10,000 for empower license to work offline on your PC and this is without the validation IQ/OQ, this is ok with me.

What do you mean offline? Just use the one on teh computer controlling the equipment... which can be validated. Purchasing, setting and managing Client server is not cheap. So if you want to compare open-Lab + Chemation to Empower price wise for small lab you need to add that cost.

I Just bought an Acquity HClass with Empower. Water's matched the quote I got from Agilent for a 1290 with Chemstation.

Agilent was pioneer in software validation. They even wrote 'the book'.

Maybe but that says nothing about the software itself.

Chemstation itself was/ is not Part 11 compliant... You had to add on the kludge of Chemstore,,, And Cerity was very problematic to say the least... which is why they changed yet again.

I have not used the new OpenLab but I have not been impressed with Agilent's approach to software design.

Do not try to give the impresion that empower has the monopoly on 21CFR part 11, because thay do not.

I did not say they do. I said that Empower has been compliant a lot longer that Agilent software (and I suspect teh others) and has most the bugs worked. I did use Millenium in the mid 90's and it was pretty buggy back then.

The reason why Empower is so big is becuase of the deception that the Empower has the monopoly on 21CFR part 11, and I hate the deceptions that was used by very pushy marketing people of Waters.

Water;s marketing can be pusshy... but that is not why I say what i do.

The reason I liked it even when it was buggier is because of how flexible it was for running things powerful it's data handling capabilities and reporting function are and have been for a long time. Chemstation never approached that.

I am not working for Agilent or Dionex, and I personaly like Turbo chrom which the software was written by chromatographers not computer scientists who are not familiar with the work we do.

I think Empower covers those bases well... But you need to understand relational databases to fully appreciate that.

You are very lucky to be able to choose the software you want to work with.
Most of us are not that lucky.

In my last job I did... Here I have less freedom, but still have some influence

So if you like Millenium, and you do not want to lern new things, it is ok too. I am not against millenium.

I have no problem with learning new things... I enjoy it... But I do care about productivity.

I just wanted you to be more objective like a scientist.

My comments are objective. I have only used Empower and Chemstation (latest verion of that) and basing my comments on that.

- karen

[bgranot]

If you want to pay $10,000 for empower license to work offline on your PC and this is without the validation IQ/OQ, this is ok with me.

What do you mean offline? Just use the one on teh computer controlling the equipment... which can be validated. Purchasing, setting and managing Client server is not cheap. So if you want to compare open-Lab + Chemation to Empower price wise for small lab you need to add that cost.

I Just bought an Acquity HClass with Empower. Water's matched the quote I got from Agilent for a 1290 with Chemstation.

Agilent was pioneer in software validation. They even wrote 'the book'.

Maybe but that says nothing about the software itself.

Chemstation itself was/ is not Part 11 compliant... You had to add on the kludge of Chemstore,,, And Cerity was very problematic to say the least... which is why they changed yet again.

I have not used the new OpenLab but I have not been impressed with Agilent's approach to software design.

Do not try to give the impresion that empower has the monopoly on 21CFR part 11, because thay do not.

I did not say they do. I said that Empower has been compliant a lot longer that Agilent software (and I suspect teh others) and has most the bugs worked. I did use Millenium in the mid 90's and it was pretty buggy back then.

The reason why Empower is so big is becuase of the deception that the Empower has the monopoly on 21CFR part 11, and I hate the deceptions that was used by very pushy marketing people of Waters.

Water;s marketing can be pusshy... but that is not why I say what i do.

The reason I liked it even when it was buggier is because of how flexible it was for running things powerful it's data handling capabilities and reporting function are and have been for a long time. Chemstation never approached that.

I am not working for Agilent or Dionex, and I personaly like Turbo chrom which the software was written by chromatographers not computer scientists who are not familiar with the work we do.

I think Empower covers those bases well... But you need to understand relational databases to fully appreciate that.

You are very lucky to be able to choose the software you want to work with.
Most of us are not that lucky.

In my last job I did... Here I have less freedom, but still have some influence

So if you like Millenium, and you do not want to lern new things, it is ok too. I am not against millenium.

I have no problem with learning new things... I enjoy it... But I do care about productivity.

I just wanted you to be more objective like a scientist.

My comments are objective. I have only used Empower and Chemstation (latest verion of that) and basing my comments on that.

- karen

Objective?

Buying HPLC hardware based on liking the software is not very objective.
The quality and productivity of the chromatography start with the HPLC hardware not the software.
You can always collect the data into A/D with any chromatography software you like from any HPLC hardware.
The Empower will not do for you the chromatography.
CDS for the lab should be a separate question from Chromatography hardware.

[varossf]

Hm, one Chromeleon user says "Chromeleon is the best" and one Empower user says "Empower is the best". I say "No software is the best". It is the user that make the software the best. Little training or little knowledge of other products often trigger these comments.

Also people know little on OpenLAB, that is clear. Introduced by SSI in 1999 (yes, 'new' software) it is now owned by Agilent. And we are proud of what we do in our software development! Agilent changed dramatically how they do their software development, thanks to the teams from SSI merging with Agilent teams.
ChemStation is now fully integrated with OpenLAB ECM, providing a central storage and security management and yes, 21 CFR Part 11 compliant functionalities to ChemStation. You can't no longer compare with ChemStore or Cerity. So the C version of ChemStation is now named OpenLAB CDS ChemStation Edition.

Now for multi vendor control and support, why don't you just use the OpenLAB EZChrom Edition? We have been controlling multi vendors since 1991, the day of SSI inception.

And don't worry about reporting, with the new Intelligent Reporter we can do more than most of our competitors.

Good luck with your selection, OpenLAB ChemStation Edition with OpenLAB ECM repository is a good choice, you will love it .

[bgranot]

Hm, one Chromeleon user says "Chromeleon is the best" and one Empower user says "Empower is the best". I say "No software is the best". It is the user that make the software the best. Little training or little knowledge of other products often trigger these comments.

Also people know little on OpenLAB, that is clear. Introduced by SSI in 1999 (yes, 'new' software) it is now owned by Agilent. And we are proud of what we do in our software development! Agilent changed dramatically how they do their software development, thanks to the teams from SSI merging with Agilent teams.
ChemStation is now fully integrated with OpenLAB ECM, providing a central storage and security management and yes, 21 CFR Part 11 compliant functionalities to ChemStation. You can't no longer compare with ChemStore or Cerity. So the C version of ChemStation is now named OpenLAB CDS ChemStation Edition.

Now for multi vendor control and support, why don't you just use the OpenLAB EZChrom Edition? We have been controlling multi vendors since 1991, the day of SSI inception.

And don't worry about reporting, with the new Intelligent Reporter we can do more than most of our competitors.

Good luck with your selection, OpenLAB ChemStation Edition with OpenLAB ECM repository is a good choice, you will love it .

This disscusion is not very objective, when it is coming from the suppliers of CDS.
We the 'lab rats' do not have choices in 99% of the time.
I am not sure if this disscusion is becoming 'marketing war' between Waters and Agilent.
Just like anything else, science looses when it is becoming like this.
It is becoming a political science more than physical science.

[Karen01]

Buying HPLC hardware based on liking the software is not very objective.
The quality and productivity of the chromatography start with the HPLC hardware not the software.

These days IMO opinion Agilent and Waters both have very good hardware. After that software has a HUGE impact on analyst/laboratory productivity. Empower can control some Agilent systems... as I said I used it for years with Agilent GC...

We are discussing CDS here not hardware... but when you start talking about the cost for stand along systems the cost of the bundle with the CDS is what matters. If Water's had not matched Agilent's price, I would have gone with the 1290 over the Acquity because I have already written my own software to make reporting and distributing Chemstation results fairly painless.

You can always collect the data into A/D with any chromatography software you like from any HPLC hardware.

Unfortunately not for things like PDA (DADs) and MS detectors.

The Empower will not do for you the chromatography.

I will say it makes doing development work a lot quicker and easier because of it's flexibility.

- KAren

[unmgvar]

Csaba it took a month to take off

besides all the very interesting points made earlier
it is important in choosing a new CDS not only to see if the software can do something, but also how it does it.

GT should also very much look into several points:
1. are you going to be Client server? is your IT ready for this?
2. if yes then how? are you restricted by SOPs in place for that?
3. will it include citrix, terminal server?
4. on what data base? oracle, SQL?
5. how are you going to back up your systems? see about cold and hot back ups, check about archiving as well it is not the same as back up and you will need it too.
6. in any case you will need retraining, check the support for that
7. one of the important part of being compliant is in the design of the reports. see how your reviewers can see what goes in the reports and chromatograms. history, last updates, versionning ect...
8. will you go and connect to a LIMS? maybe in the future, check today for that option in my view. especially if you have already a LIMS in place. do you want to have to change your LIMS as well? maybe you actually do.
9. back to reports, how many pages do you need to review today, how many will you need to have to review in the future? all CDSs provide alot of ready reporting solutions. but you always need to make your own changes. how easy is that to do, how big are those files and how many pages?
10. most of the mistakes or faslifying is made in or going to the reports. see if the user rights and privilieges are easy to set up to make it harder to do those mistakes. for example, the user needs to save all related files before reports are generated. user can change only the chromatogram diaplay and not the other sets of parameters, etc....
11.running the HPLC with the software these days is merely 25% of the work. the post processing is the time consumming part. see all about the integration possibilities of chrmatograms, how to set up calcualtions
12. think of paperless, most important is how easy it is to do within the sofware itself (LIMS comes back to mind again here).
13. sending to PDF files your reports. how easy it is to set up
14. administration and "QA" of the user and system data base. see how the reports look like. is there stuff you can "copy paste" for faster and easier changes when they need to be done?
15. see about firmware updates for your modules. will agilent make you pay for it? it is actually not to hard to do on your own anyway, but you might have to do it.
16. very important, are the user licenses goign to be floating?
17. how much will it all cost?

I am probably missing some other points but these are a good few to go over.
remember that all 3 of your CDS give a solution, simply is it the one that suits you?

[Karen01]

11.running the HPLC with the software these days is merely 25% of the work. the post processing is the time consumming part. see all about the integration possibilities of chrmatograms, how to set up calcualtions

Amen!

That and reporting.

LIMS is another issue big issue.

And client Sever is great for a comapny that has an It department... IMO not so great for smaller ones that don't.

- Karen

[sticktown]

We (mid-size biopharma company) are running an Agilent CDS and are far from happy with the performance of the system sofar. The software is slow and there are bugs that will require substantial upgrade work to be fixed with a lot of down time and extra work for us to prepare for. If I had the possibility to go back and redo our CDS purchase, I would definitely evaluate other alternatives.

Based on this and some other experience with Agilent software leads to that I can not recommend Agilent software to anyone working within GMP compliance. However, I consider Agilent hardware really robust and well performing.

[unmgvar]

sticktown
which type is it?
cerity, ezchrom, openlab with chemstation, open lab with ezchrom
is it a client server setup? if so then which data base type?

[sticktown]

#unmgwar
Chemstation/Chemlauch/ECM, client server setup yes.