Computer Hardware IQ/OQ/PQ

COMPUTER SYSTEM VALIDATION (CSV)
1

Hi,

I would appreciate any information on interpretation of IQ/OQ/PQ processes applied to hardware portion of computer system

Regards,

2

Hi,

In terms of computer harware are you refering to servers, hard drives, plc’s.

Could you be alittle more specific.

Regards

3

This is correct. I was refering to servers and PCs that validated software is running on.

Thanks

4

I will post my views on server qualification/validation on Monday.

I hope that you can wait until then.

Regards

5

that will be just fine and greatly appreciated.

6

In relation to qualifying a server I use the following documents

URS
FRS
DQ Design qualification
IQ
IQ Summary report
Server Configuration Checklist

Depending on the company in question all of the above documents do not have to be generated but whenever I validate/qualify a Server I generate a detailed documentation set to cover every angle.

My view is that if you have a critical application running on a server then you must have documented evidence that it is fully validated before performing the application validation itself.

For example my URS would contain sections like

  • CE Directives
  • Scope of supply
  • Server specifications
  • Backup requirements
  • Area classification
  • Equipment tagging
  • Failure recovery strategy
  • System lifetime
  • Surge and voltage protection
Recently I also had to validate a migration tool that was used to transfer the OS, application and DB from an old server to a new server. This may seem like overkill but once you have the validation tool validated then going forward any time this tool is used only a partial validation of the application needs to be performed in order to test the data integrity of the data that is being transferred.

I hope this gives you a taste of what I feel is involved when validating harware.

Regards

7

All of our Hardware qualification is done according to SOP. (except some crazy clustered Oracle servers with a SAN attached). I don’t think you could write a User Requirement for a Server. The application requires the server and specifies the requirements.

Based on these SOPs, we provide platforms to our users based on their application’s requirements. With every platform we provide the following, processor number and type, RAM, HD size, number and configuration. We also install the OS and provide the settings and patches that were applied. All this is done based on a SOP and associated form.

Last, our data center environment has been qualified removing the need for voltage testing and temp/humidity testing. (all in SOP)

8

Hi Meyert,

I take all of your point on board, but where I am working at the moment according to a recently approved SOP for server validation it is a requirement to generate a URS, now that maybe overkill but I have seen the document template and it is very comprehensive.

Most of the work I do is on a contract basis, and sometimes you just have to conform to what the company wants.

Until CSV is fully regulated (which it will never be) there is no right or wrong way to do things. If you have documents in place that prevent a 483 then you are doing your job correctly. Granted at times it might not be the most time efficient way to do things but it is all about compromise.

One of the resons i began this discussion board was to see can I bring some kind of uniformity as to what people are doing out there. As this forum grows I will be developing a set of results as to what is happening out there.

Hopefully common occurences will emerge

Best Regards

9

Graham,

Great, I hope I didn’t come across as judgmental. I think I have found a more efficient way to do it and like to let people know. I feel your pain when it comes to working at client site’s. Sometimes they (clients) can come across as experts but when you ask them why 6 times, it usually ends up that somebody told them that was the way it had to be and they just adopted it as fact. I will try to be cognizant of the fact that you are trying to standardize. Always remind them that GMP does not stand for Generate More Paper.

Regards

Tim

10

[quote=meyert]

I feel your pain when it comes to working at client site’s. Sometimes they (clients) can come across as experts but when you ask them why 6 times, it usually ends up that somebody told them that was the way it had to be and they just adopted it as fact.[/quote]

I’m glad i’m not that only person experiencing this, sometimes I feel that my good idea’s are just a waste of time, what you have said is exactly correct. They hear of a way to do it once and that’s it, it always has to be like that.

I don’t know what the solution is to this at the moment but I will keep going until some uniformity is applied to this crazy job!

11

thanks a lot