Does one have to conduct validation for Computer Servers to meet FDA regualtion? If yes, anyone have any ideas how we should go about it?

Does one have to conduct validation for Computer Servers to meet FDA regualtion? If yes, anyone have any ideas how we should go about it?
In short the answer is yes! I would review 21CFR11 to get a general understanding of the issues. I would highly recommend you find a consultant who is familar with the necessary protocols if you find after reading Part 11 that you do not have the expertise.

Noted with thanks./

You only have to validate software for its intended purpose.

You only have to validate software for its intended purpose.

There is lot of information on this subject. I have attached a weblink from the FDA website - http://google2.fda.gov/search?client=FDA&site=FDA&lr=&proxystylesheet=FDA&output=xml_no_dtd&getfields=*&q=software+validation

You validate software.

You qualify the hardware. I would suggest that you check out the GAMP organization at http://www.ispe.org.

They have all kinds of templates suitable for validation in a pharma or medical device environment.

If you just need hardware qualification templates, I might have some available.

You validate software.

You qualify the hardware. I would suggest that you check out the GAMP organization at http://www.ispe.org.

They have all kinds of templates suitable for validation in a pharma or medical device environment.

If you just need hardware qualification templates, I might have some available.

Thank you, you used the correct term. After reading your reply it occured to me that I should have said YES to qualify :)

Regulations require Computerized Systems to be validated when they support
GxP Processes or hold GxP data which essentially means that the data center, DR Center, Datacenter support systems like UPS, HVAC etc, Servers, Network and applications need to be qualified. Typically one needs to follow IQ/OQ/PQ Methodology to qualify the above systems.

Thanks.

There are 2 sections regarding computer validation- 21 CFR 11.10(a) and 820.70(i).

Remember, part 11 does not mean IQ/OQ/PQ/PPQ prospective validation of the automated system to perform according to your predetermined specs (this is what 820.70(i) is about), but to the validate the system against the other part 11 requirements.

If the computer server has any program/file which is under 21 CFR 800 series (803, 806, 820, 821, etc.), then it has to be validated. Additionally, if there are other programs/files (non FDA related- such as payroll, etc.) and they are revised (or will be added to the system), you have to make sure that these other programs/files do not cause problems with the FDA related programs/files.

:)