Empower software validation

[aceto_81]

Hi,

as Windows XP isn't supported anymore, we are facing an upgrade from Emp2 to Emp3.
As we are in pharma, we need to validate our systems.
Do we really need to write URS for our Empower software, or can we get away by using the sQT tool from Waters?
What is the least painfull way to get a validated CDS?

Ace

[xyber007]

Why are you upgrading to Emp 3? It is a lot more difficult to use. My lab tried it with one HPLC and gave up and we are still using Empower 2 on the other 13 HPLCs we have.

[Sergia]

I would say yes because you need to validate the system for your requirements and usage but not the software package.

[aceto_81]

We are facing more and more IT related problems and want to upgrade to newer PC's, with Win7 instead of XP.
So we need to make the jump.

And then we need User Requirements
That's a lot of work to do...

Thanks for your replies!

[Hollow]

What did you use last time?
maybe you can reuse the old URS.
Or you just go with Win7 x86 (32bit) and Empower2.
Empower3 is 64bit version, but the one that will go on in future. Make sure you'll get win7x64 for Emp3 and also check if all of your systems are supported by Emp3.

But for usage, I don't think it's more difficult, I didn't had any problems. Almost the same since Millenium32.
Ok, there are some known bugs, but also some new features.

[aceto_81]

Our previous installation if from before the requirements for user requirements.

Win7x86(32 bit) and Empower2 aren't compatible?
We can't install it.
Unless you know something else?

Not all our systems are supported, so that's what it's make so pricey.

For usage, I don't suspect any problems

[Hollow]

hm, maybe I'm wrong, sorry.

I thought we had it on Win7 in former Company but probalby it was still XP.
Are all the system language variables set to English/USA (if you live outside of US), as Empower will check that prior installing.

[tahir81]

Hi,
We are asked from regulatory agency for the validation of our Empower 2, we asked waters but they are charging extremely high. Can anyone know how to perform the empower 2 validation or to let us know how can we get it done.
Thanks in advance

[SHERIFV4]

YES, WHERE ARE YOU LOCATED?

[tahir81]

YES, WHERE ARE YOU LOCATED?

Our company is in Lebanon (Middle East).

[bundy5555]

No one here will tell you how to validate your Empower CDS because you need to validate the software based on the user/functional requirements and system configuration specific to your organization. You can't just rely on the validation protocols from Waters for validation. Regulator will not accept that. You need to perform additional validation (on top of the Waters validation protocols) base on your own user/functional requirements, software configuration, operating system, backup, restore, security setting, and IT infrastructure.

Hire a consultant or contractor to do it properly for you. It is cost of doing business. This also apply to your other systems.

[SHERIFV4]

YES, WHERE ARE YOU LOCATED?

Our company is in Lebanon (Middle East).

Hi

I can send a full Empower software validation IQ and OQ ,but I will need some help to access your computer to complete software protocol and do the Empower validation procedure

Please, send to me your email
Regards


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