The US Food and Drug Administration (FDA) issued the final version of "Title 21 Code of Federal Regulations (21 CFR Part 11)" in 1997 to promote and reinforce its rule on electronic record keeping and the use of electronic signatures. The regulation, created in reaction to the growing trend among lifescience companies to use the Internet to speed up communications, provides the framework in which companies are able to produce, store and provide secure access to electronic records; the scope of the regulation includes any area where paper-based records were formerly required. Key areas of the regulation include authentication, access control, audit trail, data protection, signature manifestation, etc.

In response to 21 CFR Part 11 and cGMP, DeltaTRAK introduced the FDA 21 CFR Part 11-compliant In-Transit FlashLink^® Data Manager software in October 2005 and followed, in April 2006, with the IQ/OQ (Installation Qualification / Operational Qualification) Protocol for the Data Manager software. Both products are critical tools for lifescience cold chain management

The FlashLink Data Manager is a comprehensive data management tool for use with the In-Transit FlashLink Data Loggers that has Shadow Log™ fail-safe technology. The software automatically tabulates and graphs data downloaded from a FlashLink data logger. Each data logger record is then analyzed and given a "PASS" or "FAIL" status based on degree-minute and other test criteria, making shipment acceptance or rejection decision easy. All trip data are stored in a secure database, allowing future queries and analysis. Beyond mere compliance, it has an innovative, built-in utility to corroborate with organizational SOP (Standard Operating Procedures) in accordance with cGMP. The software provides data retrieval and analysis tools that are easy to use and visualize, saving critical-

decision-making time. The software offers complete activity audit trail and password protection, making record management easy and secure.

The DeltaTRAK IQ/OQ Protocol provides users with step-by-step guide to electronic record system software validation and data management offered by the Data Manager software. This eliminates the time consuming process of users having to develop their own software validation protocol from scratch. The IQ/OQ Protocol comes complete with software setup instructions, data validation verifications and references.

"The In-Transit FlashLink Data Manager Software, with the IQ/OQ Protocol, greatly enhances the overall manageability and reporting capability of data gathered by the DeltaTRAK In-Transit FlashLink Data Loggers. This enables users to better meet data integrity and security requirements defined by the FDA 21 CFR Part 11 and in support of their cGMP. Trip data and reports can now be compiled, analyzed, validated and presented in much simplified and guided ways not previously possible," says Fred Wu, president of DeltaTRAK.

FlashLink Wireless is a wide area real-time monitoring and recording system. It provides for user defined set up, continuous monitoring and complete management reporting for temperature and humidity. It meets or exceeds HACCP, QA and regulatory guidelines for the maintenance of environmental monitoring records. Sensors may be placed at any location to be monitored, such as cold rooms, cabinets, refrigerators, freezers, computer rooms and dry incubators.

Observations are collected continuously around the clock, with no human intervention. Alarm feature calls each person on a user defined phone alert list until contact is made. A prerecorded message is relayed, and the contact person verifies the call by pressing the "*" key.

Reasons for Using FlashLink Wireless
► These locations usually contain environmentally sensitive
     and expensive materials.
► Risk abatement
► Labor savings
► FDA, QA or other regulatory guidelines require a system to
     monitor environmental conditions.
► Report Generation
     - Secure database management system
     - Review, sign out, and print logs as needed
► Reliable and Fully Automated
     - Computer, sensors and software do all the work.
     - Accurate observations received every 60 sec.
     - Tracks and logs all data collected by the system.
     - Eliminate human error in data collection and recording

►  Basic setup: 418 MHz or 900 MHz Starter Package-sensors and additional repeaters are available for order as needed

►  FCC Part 15 compliant radio system unlicensed (no operating license required by the FCC)

►  AC-powered receiver and repeater; battery powered sensor

►  Each receiver/system communicates with up to 100 sensors and with different temperature and humidity sensor combination

►  Sensor transmits captured data to repeater/receiver every 17 seconds assuring at least one complete data transmission each
      60 seconds

►  Sensor transmits to repeater/receiver from up to 180 meters or 600 ft. line-of-sight; repeater transmits to repeater/receiver from up
      to 396 meters or 1,300 ft. away line-of-sight

►  Mesh radio network topology guaranteeing sustained connectivity

►  Frequency hopping technology to minimize local radio frequency interference (RFI)

►  Multiple alarm options: audio notification, email and cell phone calls

►  Receiver connects to PC/Laptop with FlashLink Wireless Software (standard or SP Manager) for data download, storage, display,
      analysis and reporting

►  Software tracks and logs all reported data and displays data graphically

►  High quality, secure data management and reporting system

►  Operational 24 x 7 without manual intervention

►  FlashLink Wireless System with SP Wireless Manager software allows remote data management anywhere in the world via
      the Internet