Software validation - network and computer system validation


i am in charge of the software validation in company under the 21 CFR part 820.
I need some explication for this work. What is the diffrence between Software validation, network validation and computer system validation.
Which part i have to do or are they similar.
I know that we have to validate software for our intended use (21 cfr part 820) and be compliant with the 21 cfr part 11 but i never hear somethionf about the computer system validation.
Thanks for your answer … and sorry for my bad english.

There is really no difference between all the systems and equipment you listed; when it comes to validation.
Validation (in the pharma/bio/medical industries) is the verification that any piece of equipment is installed and performs as the end user specified in their User Requirements Specification. (URS).
So your first task is to get good quality URS documents in place for each item / system; that is to be validated. Without this document, you have nothing to inspect or test to.

Alex Kennedy

A computer system is a combination of software, hardware and the related controls. If you want to validate a computer system, you qualify the hardwarem, asoftware is running on, the software itsself and the related controls systems.

You can validate a software regardless the controls and the hardware. Then you have got the documentetd evidence, that the software does what it is supposed to do. If you want to use the software in your gxp environment, you have to do at least the IQ and some functional tests as well as partially risk based jiustified a pq.

network qualification sounds like infrastructure qualification. The requirements for IS qualification are a little bit different to software validation.

Nevertheless, starting point is always the usr, thats right.



I just want to confirm the key role of URS’s - and not only for validation purposes, but also for reaching this too often missed goal of delivering a fit-for-purpose, reliable and convenient system at the end of your implementation project! Just remember URS’s govern both the left and the right branches of a classic “V model”…

This said, and since you present yourself as a beginner in computer system validation, my advice will be that you could save lot of time and headaches by basing your approach on a well renown industry standard, I mean GAMP 5. There are hundreds (thousands?) of websites, forums, trainings and seminars about it.

Hope this will help. Good luck!

Benoit Duchiron
Senior Consultant, Propharmact
+33 6 16 70 51 59

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