As the regulations for food and pharma' get closer together in nature an overarching guidance is emerging which is related to risk aversion and risk mitigation planning.
A new release from DeltaTrak® offers possible tracking solutions for import/export operations. Single-use and compact in size, DeltaTrak® says that its FlashLink Mini PDF In-Transit Logger was developed for streamlined ease of use.
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.
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