Tracking Temperature Deviations…

Case Studies

Yikes, someone left the package out in the heat!

Problem:

Your drug must remain within a set temperature range at all times. How are you going to ensure drug that experiences a temperature deviation is not distributed to subjects?

Your packaging and transport vendor(s) will record temperature deviations that occur between the manufacturer and the clinical site. Great! But what about the IRT’s inventory tracking? How does it know to hold that drug? And what to do with it next?

Solution:

When the site receives the shipment, they will have to answer the question, "Did the shipment experience a temperature excursion?" before being able to proceed. If yes, Veracity Logic’s IRT gives you the power to make important decisions:

  • You can specify which types of temperature excursions occurred – i.e., ambient, refrigerated, frozen, or all three.
  • You can specify whether some or all of the kits in the shipment were affected.
  • After reviewing the temperature excursion details, you can decide to reinstate a kit or a shipment and make it once again ‘available’ for assignment to subjects.
  • Conversely, you can quarantine the kit or shipment after reviewing the deviation details. Quarantined kits will remain unavailable for assignment and will automatically be replaced in inventory in the next shipment.
  • You can designate kits and shipments for destruction or for return to the warehouse.

In other words, Veracity Logic’s IRT gives you the flexibility to meet real-life scenarios with real-life solutions.

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