Hi!
i need to know if i am doing a IQ to pass an audit for FDA, if i can attach a cd with all supplier´s documentation either i have to attach it on paper and all
sign it
thanks!
Without going off on too much of a rant, let me say that there’s a lot about this post that is troublesome.
First off, the mindset of doing an IQ to pass an FDA audit (inspection) is troublesome. FDA doesn’t require an IQ; it requires that equipment is qualified and processes are validated. And that’s for good reason: to ensure that you can consistently manufacture the product that you have demonstrated is safe and effective. Your IQ should support your claim that your equipment / processes can support that claim.
The second concern is the idea of just checking a box for supplier’s documentation (which, if you just have it on a CD that is dumped into some document repository, is what you’re doing). The supplier should be giving you information that you need (maintenance procedures, calibration procedures, user’s guides, etc.). These need to be available (as with anything in doc control) at the point where they are needed. Granted, if these are JUST to capture design, then they can be archived as long as they’re readily available if a design change is needed. So to answer the question, it would need to be clear what the documentation is and why you’re receiving it.
Finally, with respect to attaching it (the CD?) to paper and signing for it, there’s no regulation for what you’re describing. You may have internal procedures that require you to approve acceptance (?) of the documents (on CD) or enter them into document control.