Can anybody clarify for me,

If a system is already validated and you want to add a new interface,
Should the validation plan for the new interface include IQOQPQ ?


I think, Until the functionality doesnt change no need of revalidation. But IQ is required because of new interface. Please do double check.


So, this interface will lead to new functionality, so I’m presuming OQPQ for these or a combined spec,

What do you typically test for in IQ ? if it is an interface to CAT 5 system

Sorry Becker. I dont have answer for your question. I dont know much about computer validation. I told what i knew.