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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.

The current buzz word in technology today is The Internet of Things (IoT). The definition is typically understood as “everyday objects having network connectivity, allowing them to send and receive data.”

DeltaTrak’s Director of Strategic Sales, Robert Bright, presented the FlashTrak Telematics solution and its product emulation capability to the Supply Chain Logistics Council during the United Fresh Midwinter Leadership Forum. This pioneering technology, with mobile and facility applications, gives produce growers, shippers, and receivers the ability to monitor the actual product temperature from harvest through the pre-cooling process, and during transportation and storage.

Today there is an ever growing trend toward Cloud Computing, with many companies entrusting their data to an outsourced agency. As we approach the New Year, it seems like a good time to review all areas of your supply chain where risks might exist, and to mitigate these issues with risk aversion planning that will meet GDP compliance.

It seems like every time you pick up a trade journal, some company or the other is offering a last mile solution.

Whether this is a special package that has been validated for "x" amount of hours, or a device no different than a basic chemical indicator that will give you a good or bad forensic analysis after the event.

Ease of mind is what you want when you transport a large quantity of consumable product. Trust is what you need in the solutions that are monitoring your various perishable commodities, especially once they leave your domain. DeltaTrak’s reliable temperature monitoring solutions are made specifically for all points in the cold chain process.

When any QA department turns their attention to data and security most of the focus is on how this is controlled internally in relation to common regulations like - 21 CFR Part11, Part 820, GMP, etc., and of course patient data regulations like HIPAA.