Guide for IT Infrastucture qualification

Dear All,

I have a need to retrospectively qualify our IT Environment and I was looking for a GAMP Guide.
We already have a GAMP 5 Guide called: A Risk-based Approach to Compliant GxP
Computerized Systems, but the IT Infrastructure Control and Compliance is more
detailed regarding the IT Infrastructure, and also referenced in the GAMP5 guide.

My problem is that the IT Infrastructure Control and Compliance Guide is GAMP4
based. Should I still use and reference this Guide?
If not, has somebody hint which Guide could I use?



If you are going to remediate the Qualification as on date, I will suggest mention the recent references only i.e. GAMP 5. Asses the existing system, identify the gaps & either rectify them or build a rational based justification for the same.

Happy Reading !


There is no problem in using the GAMP 4 Infrastructure Qualification Guide; GAMP 5 talks more about a risk based approach to validation as a whole so this should be taken on board. In addition, make sure your qualification strategy aligns with that of your local standards and those of any clients. E.g. if you have US clients, make sure you qualify against standards they will recognise and accept.

Hope this helps.

Check out:

This Good Practice Guide is still valid and may be used.