CAP inspection for LAB – Testing requirements

Absolutely not.  That interpretation of the CAP regulations by your lab folks is way off the mark.  Imagine if every application took that approach?  We’d all be doing nothing but continues integrated testing of all our applications!  I’m attaching a word file of some of the CAP regulations, downloaded today from their website – so these are the most current.  I believe your lab folks are misinterpreting the intent of some of these regulations – when they make updates to THEIR system, they need to do that full-blown testing.  But, that logic does not apply to changes made to systems that touch the lab application.  I challenge them to find the regulation that MANDATES them to do what they’re conveying to you must be done.

Regards,