In an effort to cut costs and manage key areas within your cold chain logistics operation, DeltaTrak is offering a unique data logging solution, along with a fully documented Master Validation Plan (MVP).
In conjunction with our professional services partner, Modality Solutions, major drug and biologics companies can now purchase DeltaTrak’s single-use, FlashLink® PDF In-Transit Data Logger, and also receive a fully documented DQ/OQ (Device Qualification/Operational Qualification) validation report as part of the Master Validation Plan.
DeltaTrak and Modality Solution’s combined expertise ensures that companies will be given optimal risk mitigation and regulatory compliant temperature monitoring services and solutions. This partnership can aid cold chain logistics operations by eliminating costly errors, reducing QA product assessment times, and provide 21CFR, Part 11 Compliant reports, which can be automatically downloaded from the logger.
As commonly shown, the cause of approximately 90% of all cold chain errors are due to human blunders. DeltaTrak’s FlashLink® PDF In-Transit Data Logger is equipped with our patented Shadow Log™ feature, which ensures shipments are monitored and a trip reading is still produced, even if the operator forgets to start the logger. No software is required to download data, and since there is a built-in USB connector, no special reading devices are required. Since the logger has on-board software, no PC is necessary and the receiver has the option to download data directly to any printer with a USB port. Trip history stats are available in human-readable format on the unit LCD screen. The logger is also equipped with high/low alarm indicators.
With Risk assessment investigations, Shadow Log™, and DeltaTrak’s DQ/OQ Master Validation Plan can help to eliminate costly QA product assessment times and provides to the customers with established quality procedures to verify that the FlashLink® PDF In-Transit Data Logger will operate as expected. The added benefit of this documentation coupled with the Shadow Log™ capability are a critical addition to any risk mitigation plans.
Imagine how your risk mitigation planning initiatives will measure up once you’ve integrated DeltaTrak’s PDF loggers and a fully documented MVP comprised of Modality’s expert solutions. Yes, you guessed it - your total cold chain strategy will be streamlined and efficient.