A well-executed ColdTrak provides clients with enterprise-level cold chain visibility

According to Fred Wu, president of DeltaTRAK, Inc., an enterprise-wide cold chain solution is the optimal way for companies involved with in-transit monitoring of perishables to address and ensure product quality, shrinkage and waste. DeltaTRAK, founded in 1989 as a premier supplier of portable environmental test and measurement system, has several patents on technology that makes in-transit environmental monitoring efficient and reliable. In this premier newsletter, Mr. Wu explains why end-to-end cold chain management solutions offered by DeltaTRAK are the optimal way for companies, large and small, to improve GMP (Good Manufacturing Practices), and comply with regulatory requirements.

The days of "tag, read and forget" in-transit monitoring are long gone. Today's companies involved in the shipping, receiving and storage of perishable goods have to develop, implement, monitor and upgrade their cold chain programs to meet customer quality expectations, achieve cost efficiency and foster supplier relationships. This requires a strategic approach to cold chain management and it starts with a clear vision for the program, followed by developing the right program architecture and using the right tools procured from the right business partner.

DeltaTRAK’s ColdTrak program, a unique cold chain management solution, is founded on a simple premise: offering clients with process-oriented tools and benefits for end-to-end management of the entire cold chain. Although individual in-transit activities are important, having the ability to manage the entire cold chain and make use of in-transit data to develop models for continuous improvement is critical to a successful, long-term cold chain management program. With years of experience supporting the in-transit monitoring business, DeltaTRAK personnel are in the best position to, by examining data collected from the clients' cold chain path, advice clients on where they are meeting their cold chain objectives and where improvements are needed.

The DeltaTRAK In-Transit FlashLink Data Loggers with Shadow Log technology and FDA 21 CFR Part 11-compliant Data Manager are most unique and productive for cold chain management applications.

The In-Transit FlashLink Data Loggers are available in for logging periods from 5 to 75 days, depending on the model, and two temperature ranges. Models 20011 through 20014 operate from -40°F to 150°F (-40°C to 66°C) and Models 20041 through 20043 go as low as 112°F (-80°C) for dry ice and other low temperature applications. The accuracy of each data logger is +/- 1°F (+/- 0.5°C). Each compact data logger holds 3,800 data points in memory (time, date and temperature readings).

The fail-safe Shadow Log™ technology provides 24 x 7 automatic data recording even if the shipper forgot to manually start the unit. With this unique feature, the trip data is recorded in "shadow mode" and can be downloaded for analysis.

In-transit data can be directly downloaded and printed for on-the-spot "PASS/FAIL" load acceptance or rejection decision-making via the compact DeltaTRAK Model 20111 printer without using a PC. To satisfy formal data reporting requirements,

the trip data can be downloaded to a PC in 5 seconds using the standard In-Transit FlashLink Software which is available from DeltaTRAK's company website (www.deltatrak.com). For mining trip data to facilitate current and future business analyses, the FlashLink Data Manager is the "tool-of-trade" as this software automatically tabulates and graphs the downloaded data and all trip data are stored in a secured database. This software is fully password protected with individual access rights to each key function and it offers complete activity audit trail, making data and record management easy and secure.

Another key feature of the FlashLink Data Manager is that it allows end-users to manage reports in compliance with FDA 21 CFR Part 11 guidelines. Major areas of the FDA guidelines include authentication, access control, audit trail, data protection, signature manifestation, etc. Beyond mere compliance, the FlashLink Data Manager offers an innovative, built-in utility to corroborate organizational SOP (Standard Operating Procedure) in accordance to cGMP (Current Good Manufacturing Practices) most crucial to quality control processes in healthcare or bioscience companies.