21CFR11 software for QC lab

[GT]

Dear all,
we are evaluating to upgrade our HPLC / GC software from Chemstation to another sw to become 21CFR11 compliance. The software are:
Dionex: Chromeleon new version 7.1
Waters: Empower
Agilent: EZChrom or Open lab
Could you post your experince with these sw, used according 21CFR11?
Thanks to all
GT

[EmpowerGuru]

all the large pharma companies and even smaller generic use Empower 2

[varossf]

Interesting, what about all these pharma companies using EZChrom, Chromeleon or OpenLAB??
You will have a swift migration to an OpenLAB based system, even with maintaining the current ChemStation workflows and methods. If you go to another product a lot of work goes into setting up the methods etc. OpenLAB ECM can be used as the backend for the ChemStation systems, providing 21 CFR Part 11 compliance, central storage, central user management (with Domain integration), central security and roles setting (any number of roles you can make) and it also adheres to GxP with built-in Record Retention Policies. With the new Intelligent Reporter you make fast nice and sometimes complex reports against the OpenLAB database (Oracle or SQLServer). There are template reports for e.g. dissolution and content uniformity. Charts can be added to do your cross-sequence statistics and instrument utilization reports are ready to run. If you want central running ChemStations you can toss in the ChemLaunch software.
But wait, there is more. OpenLAB ECM is a SDMS+, it can also capture any information from any system. It captures printed reports in PDF and allows you to go completely paper free. With Empower you need to toss in Nugenesis and there is no solution for Chromeleon, although they would probably advice you to buy OpenLAB ECM to archive the data from Chromeleon.
If you have more questions feel free to contact me!

[tom jupille]

Just a reminder to all about etiquette around here: if you have a "commercial" involvement with the product or technology you are discussing, please be sure to indicate your affiliation, either in your signature line or by mentioning it in your post.

And now, back to our regular programming!

[Csaba]

If you don't have ChemStation, I would recommenedd to keep the "ordinary" CDS information in the GLP compliant CDS and just go through the problem of importing data into OpenLab from other non GLP compliant systems. That will minimize the headache and cost significantly.

One should remeber, even if big pharma have a certain solution, that does not imply unconditionally that it is cost-effective and good solution. it might be a certain story behind it that explains why it got implemented as it is. If one starts from scratch later, another solution might be better.

[unmgvar]

GT

of how many instruments are you talking about?
are you also moving to Client server installation? if yes then are IT and lab working together on the project?
how were you doing the data back up until now?
have you thought of how you want to do it now?
do you know the terms of hot or cold back up?
how do you calculate results right now? is it with Excel?
do you intend to go for paperless, so be in the broader requirement of CFR 21 part 11 or do you keep hard copies archive and so will choose the lesser requirement for cfr 21 part 11 compliance

remember the softwares provide you tools that allow you to comply but you need to create a work flow that is compliant

also if memory serves me right, Chromeleon can easily transfer all your data from chemstation. the question is do you want it?


many questions and also a lot more that will be relevant only to you and will need attention to.
if you do not know the other softwares ask for a demo on a small scale to see the capabilities and ease of use. complying is one thing doing it intelligently is another thing.
remember that is why chemstation is not complaint, cerity dead and agilent bought cyberlab from ezchrom and calls it openlab.

[jonp]

Is Chromeleon 7.1 21CFR pt11 compliant?
My understanding was that 6.8 is the pt11 ‘compliant’ Chromeleon version, with 7 getting those features at some point in the future. 6.8 is the version we use and I would recommend it. We use the security features but not the full paperless features, review approve etc.

[GT]

Dear All,
thanks a lot for your comments.
Some answers to unmgvar
from 5 to 9 instruments
Yes, more or less togheter!
"hot or cold back up", I don't know the difference
No excel, directly with Chemstation
Hybrid system, papers with e-records
For jonp
7.1 will be available part 11 complies from the end of November, so Dionex person told me last week.
What about percent of control of Agilent HPLC 1100/1200 with others SW?

GT

[varossf]

Just for the record, Agilent bought SSI, EZChrom is a CDS in workstation and Client/Server. OpenLAB is a product family consisting of Data management (ECM), workflow management (BPM), Instrument Control Management (ICM) the built-in OpenLAB CDS, and OpenLAB ELN.
ChemStation gets it's compliance if you integrate it with OpenLAB ECM.

But not a single application is compliant unless you provide the required documentation and validation around it. Compliance is not just the technical solutions in the application you implement!

If you need detailed information on how to improve your lab and workflow please send me a private email, as I cannot advocate too much my solutions without violating the intention of this forum.

[Bluesman75]

A 21CFR11 solution starts before you have even chosen your software.
Before you even think about which software package to go for work out what you actually need. This is call an end user specification and without it you can not know if you are buying the correct software. For example will it fully control the instruments you have?

[jonp]

As much as I would recommend Chromeleon 6.8 I would be a little wary of any new-to-the-market or new-feature-to-the-market datasystem.

I say this after being the first customer in the UK for a major datasystem update (none of the above): you have to get your head around a new system and have the teething problems of a system without the problems yet fully ironed out on top of that.

Having said that: someone has to be the first, and if 6.8 is anything to go by I think it’ll be a good product in the end.

As for the Chromeleon – Agilent 1200 link, in 6.8 it works well, full control and even the calibration functions, it's better than some of same manufacture equipment/datasystem links in our lab.

[Consumer Products Guy]

We use Agilent ChemStore electronic data security, maybe from a decade ago, on half-dozen instruments (ChemStation A.09).

Yes, one has to enter ChemStore password every hour or 2 after computer non-use. After that use of the ChemStation is 99.5% the same, just the results have to be assigned to a Study from a dropdown box. And when the Database reaches about 650MB, then a new Database needs to be created (good time to back up on a CD).

We've never evaluted any other vendor's software for this.