I guess by now the rumors are true and the FDA has recently (late 2015) announced that it will begin much more stringent inspections for compliance to 21 CFR Part 11 regulations related to and concerning electronic records, audit trails concerning metadata, and signatures that need to be actual and trustworthy, plus validation of products.
Refrigerator monitoring for cold chain drugs is one of the main essentials for insuring efficacy and safety of the drugs stored within these units, and a compliance requirement from the FDA, CDC, WHO, etc.
When we use the word Smart and couple this with Solutions, then add in the term Last Mile, or Patient Mile, it seems everything you read has either a different solution, or interpretation related to the need!
The ICH and other globally focused organizations are working diligently to introduce more consolidated forms of quality regulations, like the ICH Q10, for the management of the quality of drugs related to cold chain distribution and drug security.
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