Parameterised IQ Protocols

Another question from the 21CFRPart11 forum - not strictly relating to ERES, but interesting all the same:

Q. I am wondering about a project and how the FDA could see it as a validated way to execute qualification protocols.
 
There is the idea: we validated our document management system, where we validated the electronic signature, and the documents could be developed as pdf forms, where some fields are able to be written... and in this case, we could develop our qualification protocols as a pdf forms, with the mandatory fields for protocols, able to be written, and filled with the qualification info.

Is this a situation which FDA could see as a correct way to develop and execute protocols?

A. There should be no problem at all with the approach, as long as the final protocols (i.e. with the parameters entered) are still subject to peer review prior to (and usually after) execution.

We do this with such documents and we have also used a similar approach using HP QualityCenter (developing the basic protocol as a test case in QualityCenter and entering the parameters for each instance of the protocol that is being run).

The peer review process is of course also much simpler, because the reviewer can focus on the correct parameters having been specified rather than the (unchanging) body of the document.