Network Qualification

COMPUTER SYSTEM VALIDATION (CSV)
1

Hello,

Can anyone give me some advise on Nework Qualification.

What level of qualification/validation is required to mensure that a network is fit for intended use. I am currently embarking on a network qualification project and was wondering what the general experience has been out there.

Any input or reference to material on network qualification would be most useful.

Thanks in advance

2

Graham,

Never done one myself but have listened in on various group discussions. As you might expect, performing a risk analysis is recommended to scope the activities. Beyond that, I did a bit of poking around and found a few reference materials:

GAMP IT Infrastructure Control and Compliance
ISACA and IVT Network Qualification Guide
I saw a post that IVT published a “Proposed Standard for Network Qualification” in their Validation Journal but I can’t find a free copy anywhere. Maybe you can contact them?

http://www.labcompliance.com/solutions/free_literature.aspx?sm=b_d

  • some free literature from Dr. Huber / LabCompliance.

With the exception of general use of Dr. Huber’s materials on LabCompliance, I don’t have these / never used them so I can’t speak for their quality. LabCompliance stuff has always been pretty useful. You might contact Dr. Huber directly - he’s usually quite willing to help. Hope this helps. I (for one) would be interested in hearing what you come up with.

3

Thanks Yodon for the links and reference I will research in the coming weeks, hopefully I will get around to writing an article about it.

Regards