Hi I was wondering if anyone could answer this question:

I am writing an I/OQ for the GCMS however I was courious to know if you have to write seperate validations for say the autoinjector and the software that is used to operate the GCMS, or can it be the same protocol and just add in three different sections for the intallation and operation of the autoinjector, GCMS, and the Software.

I was also wondering if there were anymore sections that I need on the protocol or take off the protocol. here are the sections:

Purpose
Scope
Responsibilities
Equipment description
references
deviations
validation plan
tables

I know there is acceptance criteria, however I don't remember if I need it on the protocol or just the final report.

Any input would be great!

Thanks!

The choice is yours :)

But I would prefer to combine all the "associated" ones in a single protocol as the Equipment Qualification exrecise becomes simpler and easy to handle.

In your porotocol, you could have a different section titled, "ASSOCIATED EQUIPMENT" whereby under IQ, you could list down all the relevant details, under OQ, you could qualify them operationally.

Since PQ involves testing of the entire system, you could state in the protocol that the PQ of the software and autoinjector would be combined into a single system performance and robustness.