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Need for an IQ Report?

I have engaged an external software developer to execute full validation i.e. PDQ/IQ/OQ/PQ of their software. I note that they do not supply an IQ report but do supply a very detailed IQ Protocol.

Is an IQ report necessary ?

I would ask for an IQ report, it is a standard document giving you a snapshop of how the IQ execution went, usually an auditor would ask to see a report first to give them a quick summary of what went on in the execution.

One other point is it a good idea to get the software developer of the software to do the execution, I would have thought an independent analyst would be a better idea.

Thanks Graham,

I can understand the concerns in having a developer validate their own software. In this instance, they are more reseller than developer which probably holds similair concerns.

My intention is train up on software validation so that we can execute validations internally.

No problem if you need some external guidance we have a number of consultants that could help develop and review your work.

Just a thought if you need assistance.

Regards