topic Re: FDA Validation in Operating System - HP-UX

FDA Validation

Grayh — Fri, 17 Oct 2008 14:20:04 GMT

What is FDA Validation.. and how can I perform FDA Validation on my rx Servers...

Is there a different approach for rp servers

Re: FDA Validation

John Guster — Fri, 17 Oct 2008 14:26:12 GMT

Your organization will have a set of rules /policies per FDA guidlines, you need check each policy on your systems to see it the systems have been in compliance with the policies.

Re: FDA Validation

Grayh — Fri, 17 Oct 2008 15:02:57 GMT

Thanks for the clue.... Could you give me some sample documents as to how the process is or to get acquainted to it..

Some examples of how it will be like...

Cos I have heard that in the next week I will have to do a FDA validation on all my servers.. and i don't even know the full furm of FDA.

Re: FDA Validation

John Guster — Fri, 17 Oct 2008 15:20:54 GMT

Most pharmaceutical companies require SA, like you, be FDA certified to be put on the job. Here is a big hole here already in your case. You better off ask your boss about that...

Re: FDA Validation

Duncan Edmonstone — Fri, 17 Oct 2008 16:11:47 GMT

I would go further than John in this regard and say if you are building/managing FDA validated systems and you don't know what FDA validation is then you are definately in breach of FDA guidelines...

Now I wish I knew which pharma company you work for so I can make sure to avoid their products!

This is actually quite scary - if you are working on FDA validated systems you need to talk to your boss *immediately* about getting certified.

HTH

Duncan

Re: FDA Validation

Grayh — Thu, 06 Nov 2008 16:29:52 GMT

thanks everyone