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data protection ???

Discussions about chromatography data systems, LIMS, controllers, computer issues and related topics.

4 posts Page 1 of 1
Hi
We are having 4 HPLC system in our lab,i.e., Agilent (Chemstation) Waters (Empower) Dionex(chromeleon) and shimadzu
I would like to know of all the software which one have the best data protection system..one of the vendor recently told me Waters(Empower) have the best data protection system…
Plz pool in your views

Data security is largely a function of your lab's procedures and how faithfully you carry them out. All brands of CDS mentioned have built in archiving, security, CFR21 part 11 compliance and other management tools, so data security is not at the top of most people's list of desired features when they go CDS shopping.

I would suggest giving each system a test drive. If you anticipate significant growth of the lab, or integration with other labs, talk to the other labs and to the vendors about how they can help you acheive these ends. Got LIMS? You also need to consider the needs and computer skills of your end users as well as the cost, upkeep costs, hardware requirements and service options (and their costs) available with each vendor.

There are many factors that go into the CDS decision process and choosing one will be tough until you go through and prioritize a number of these factors. Making the right choice will be a lot easier once you have done this and talked to end users of each system and test drive them for yourself.
Thanks,
DR
Image

how do you define data protection?
the answer is mainly based upon how you are currently working and how do you intend to work in the future.

CFR 21 part 11 compliance is always what people talk about but they do not understand that compliance to it can be achieved at least on 2 levels and that for the most part many companies are no way near to need to be paper-less although they go and spend big money on the matter.

as DR said, i think that the most important for you is to first create a URS regarding what you feel are your current and future need for data protection, based upon the requirements of the regulators that you deal with or intend to deal with in the future.
the matter is very complex and sometimes in the end you will decide based upon a very few differences.
for example:
when we made our choice, we were no where near ready to implement a paper-less environment so we looked very hard into the capacity of users to change by mistake or on purpose key features of the reports prior to printing because that is also related to the protection of the data in our view.
one key feature was that any changes made would have to be saved before the user could print any information so that an audit log would have to be created and could be tracked.
the second and bigger problem with the reports is that in chromatography you always need to let your users the possibility to change the scales of your chrom.display window. but in most softwares when the users can do that then they are basically free to make any changes they desire in the report. that basically means that you can create fake printed data, you can mess up with reports that have critical calculations in them, you can fake the time of print, acquistion and so on.

The problem with ChemStation is that the actual product is not CFR compliant on its own. To do this you also need the ChemStore Security Pack bolt on. This really was a quick fix by Agilent to extend the lifetime of an already dated product.

Believe me, it shows!

Having no experience with Empower, I wouldn't like to comment.

However, having been a user of Chromeleon for nearly 6years I would thoroughly recommend this CDS for ease of use, flexibility and the desired security you are probably looking for.

Obviously though, the comments in the previous replies are highly valid and should indeed be taken into account.

Have fun!!
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